Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2026-01-02 @ 9:40 AM
Study NCT ID:
NCT05225558
Status:
TERMINATED
Last Update Posted:
2025-05-06
First Post:
2022-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627008', 'term': 'delpazolid'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'scheon@ligachembio.com', 'phone': '+82)2-6952-0689', 'title': 'Seonghye Cheon', 'organization': 'LigaChem Biosciences, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From IP administration to TOC (Test of Cure, 4 weeks after EOT*), approximately 10 weeks *EOT (End of treatment): up to 6 weeks', 'description': 'All clinically significant medical conditions or abnormalities observed from the administration of the IP until TOC were collected as AEs.\n\nIf an AE identified before the administration of the IP worsened in severity after the IP administration, it was collected as a new AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO", 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 13, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Melaena 0 [0] 2 (10.00) [2]', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Vulvovaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Escherichia test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Myocardial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}], 'seriousEvents': [{'term': 'end stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Day 14', 'description': "* 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'.\n* Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full analysis set) : The analysis was conducted on patients who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.'}, {'type': 'PRIMARY', 'title': 'Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_PPS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Day 14', 'description': "* 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'.\n* Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS(Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance\\* was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS.\n\n\\*(Sum of the number (tab) of actually taken up to the 14th day /14 days (minimum administration period)X4(tab))X100'}, {'type': 'SECONDARY', 'title': 'Overall Cure Rate by End of Treatment (EOT)_FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7 visit and EOT (up to 6 weeks) visit', 'description': "* 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'.\n* Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full analysis set) : The analysis was conducted on patients who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Cure Rate by End of Treatment (EOT)_PPS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7 visit and EOT (up to 6 weeks) visit', 'description': "* 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'.\n* Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS(Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance\\* was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS.\n\n\\*(Sum of the number (tab) of actually taken up to the 14th day /14 days (minimum administration period)X4(tab))X100'}, {'type': 'SECONDARY', 'title': 'Mortality From MRSA Bacteremia by EOT_FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Overall death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Death from MRSA bacteremia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the treatment period (from the first administration to EOT (up to 6 weeks))', 'description': '* Proportion of participants who died due to MRSA bacteremia\n* Overall mortality = (number of participants who died/number of participants in each treatment group) x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full analysis set) : The analysis was conducted on patients who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.'}, {'type': 'SECONDARY', 'title': 'Mortality From MRSA Bacteremia by EOT_PPS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to daptomycin after at least one week of administration of vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of vancomycin (including daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Overall death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Death from MRSA bacteremia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the treatment period (from the first administration to EOT (up to 6 weeks))', 'description': '* Proportion of participants who died due to MRSA bacteremia\n* Overall mortality = (number of participants who died/number of participants in each treatment group) x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS(Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance\\* was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS.\n\n\\*(Sum of the number (tab) of actually taken up to the 14th day /14 days (minimum administration period)X4(tab))X100'}, {'type': 'SECONDARY', 'title': 'Relapse Rate of MRSA bacteremia_FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from the first administration to TOC (4 weeks after EOT)', 'description': '* Defined as a positive blood culture to MRSA when previous ones were negative\n* Relapse rate of MRSA bacteremia = (number of participants with Relapse of MRSA bacteremia after clearance of MRSA bacteremia until TOC visit/number of participants with clearance of MRSA bacteremia in each treatment group) x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '* Participants in FAS who had MRSA negative two consecutive set in the blood culture test\n* FAS (Full analysis set) : The analysis was conducted on participants who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.'}, {'type': 'SECONDARY', 'title': 'Relapse Rate of MRSA bacteremia_PPS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from the first administration to TOC (4 weeks after EOT)', 'description': '* Defined as a positive blood culture to MRSA when previous ones were negative\n* Relapse rate of MRSA bacteremia = (number of participants with Relapse of MRSA bacteremia after clearance of MRSA bacteremia until TOC visit/number of participants with clearance of MRSA bacteremia in each treatment group) x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '* Participants in PPS who had MRSA negative two consecutive set in the blood culture test\n* PPS (Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS.'}, {'type': 'SECONDARY', 'title': 'Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to daptomycin after at least one week of administration of vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of vancomycin (including daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Day3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Day7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)', 'description': '* Proportion of participants who confirmed MRSA negative two consecutive set in the blood culture test\n* Clearance Rate = (number of subjects who achieved clearance at each visit/number of subjects in each treatment group) x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full analysis set) : The analysis was conducted on participants who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.'}, {'type': 'SECONDARY', 'title': 'Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Day3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Day7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Day14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)', 'description': '* Proportion of participants who confirmed MRSA negative two consecutive set in the blood culture test\n* Clearance Rate = (number of subjects who achieved clearance at each visit/number of subjects in each treatment group) x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS(Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance\\* was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS.\n\n\\*(Sum of the number (tab) of actually taken up to the 14th day /14 days (minimum administration period)X4(tab))X100'}, {'type': 'SECONDARY', 'title': 'Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Day3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Day5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3, Day 5, Day 7, Day 14', 'description': '* Proportion of participants who have positive results on blood culture tests\n* Persistent rate of bacteremia = (number of subjects who showing persistent bacteremia up to each visit /number of subjects in each treatment group up to each visit) x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full analysis set) : The analysis was conducted on participants who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.'}, {'type': 'SECONDARY', 'title': 'Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_PPS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Day3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Day5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Day7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 3, Day 5, Day 7, Day 14', 'description': '* Proportion of participants who have positive results on blood culture tests\n* Persistent rate of bacteremia = (number of subjects who showing persistent bacteremia up to each visit /number of subjects in each treatment group up to each visit) x 100', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS(Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance\\* was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS.\n\n\\*(Sum of the number (tab) of actually taken up to the 14th day /14 days (minimum administration period)X4(tab))X100'}, {'type': 'SECONDARY', 'title': 'Time to Clearance of MRSA bacteremia_FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '14.00'}, {'value': '8.00', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '18.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'by EOT (up to 6 weeks)', 'description': 'If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as clearance of bacteremia. The period until the clearance of bacteremia is defined as the period (day) from the date of the first blood culture test within 72 hours prior to randomization with MRSA positive (index blood culture) to the date of the blood culture test with the first negative result confirmed.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full analysis set) : The analysis was conducted on participants who received the IP at least once after randomization and had at least one valid efficacy evaluation result. Additionally, participants who violated the inclusion/exclusion criteria were excluded from the FAS analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Clearance of MRSA bacteremia_PPS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '14.00'}, {'value': '7.00', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '18.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'by EOT (up to 6 weeks)', 'description': 'If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as clearance of bacteremia. The period until the clearance of bacteremia is defined as the period (day) from the date of the first blood culture test within 72 hours prior to randomization with MRSA positive (index blood culture) to the date of the blood culture test with the first negative result confirmed.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPS(Per protocol set): The analysis was conducted on patients from the FAS who completed the study without experiencing major Protocol deviation and whose IP treatment compliance\\* was less than 80% up to 14 days after the first dose of the IP. Participants whose reason for withdrawal is "Treatment failure criteria are met during the treatment period" are not excluded from the PPS.\n\n\\*(Sum of the number (tab) of actually taken up to the 14th day /14 days (minimum administration period)X4(tab))X100'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Vancomycin MIC Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '0.256', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.258', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at Screening visit (baseline)', 'description': 'Vancomycin minimum inhibitory concentration (MIC) levels', 'unitOfMeasure': 'mcg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received the IP at least once and had samples collected for MIC evaluation among the 40 randomized participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Delpazolid MIC Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Combination Therapy - Vancomycin IV Plus Delpazolid 800 mg, PO, BID', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: BID, PO"}, {'id': 'OG001', 'title': 'Monotherapy - Vancomycin IV Plus Placebo of Delpazolid', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO"}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Day14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard Deviation not calculable because data were only collected for 1 participant', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}, {'title': 'End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': 'NA', 'comment': 'Standard Deviation not calculable because data were only collected for 1 participant', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening (Baseline), Day 14, EOT', 'description': 'Delpazolid minimum inhibitory concentration (MIC) level by broth microdilution (BMD)', 'unitOfMeasure': 'mcg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Set who were evaluated for Delpazolid MIC at baseline, Day 14, and EOT.\n\nOf the subjects in the SS (combination: 18 subjects, monotheray: 20 subjects), Delpazolid MIC was evaluated in 18 and 17 subjects from the combination and monotherapy groups at screening, 1 and 2 at Day 14, and 1 and 0 at EOT, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics (PK) parameters_AUC,ss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Total', 'description': 'Out of the total 40 enrolled patients, the blood concentrations of LCB01-0371 from the 15 patients in the treatment group who received LCB01-0371 (excluding the 19 control subjects who received placebo) were included in the population PK model analysis.'}, {'id': 'OG001', 'title': 'No ESRD', 'description': 'Subjects without End-Stage Renal Disease (ESRD) based on their medical history'}, {'id': 'OG002', 'title': 'ESRD', 'description': 'Subjects with End-Stage Renal Disease (ESRD) based on their medical history'}, {'id': 'OG003', 'title': 'Not Undergoing HD', 'description': 'Subjects without ESRD or Subject with ESRD not undergoing Hemodialysis (HD) based on their medical history'}, {'id': 'OG004', 'title': 'Undergoing HD', 'description': 'Subjects with ESRD undergoing Hemodialysis (HD) receiving based on their medical history'}, {'id': 'OG005', 'title': 'No HI/LC', 'description': 'Subjects not included in either LC\\* or HI\\*\\* \\*LC: Liver cirrhosis\n\n\\*\\*HI: Hepatic impairment status according to the NCI-ODWG criteria'}, {'id': 'OG006', 'title': 'HI/LC', 'description': 'Subjects included in either LC\\* or HI\\*\\*, i.e., the combination of LC and HI \\*HI: Hepatic impairment status according to the NCI-ODWG criteria\n\n\\*\\*LC: Liver cirrhosis'}], 'classes': [{'categories': [{'measurements': [{'value': '90,855.222', 'spread': '88,895.538', 'groupId': 'OG000'}, {'value': '83,671.053', 'spread': '75,411.511', 'groupId': 'OG001'}, {'value': '99,065.701', 'spread': '107,966.645', 'groupId': 'OG002'}, {'value': '112,462.317', 'spread': '111,518.903', 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'BG001'}, {'value': '66.8', 'spread': '13.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Childbearing potential', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only female'}, {'title': 'Height (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '164.15', 'spread': '6.302', 'groupId': 'BG000'}, {'value': '161.85', 'spread': '7.582', 'groupId': 'BG001'}, {'value': '162.94', 'spread': '7.009', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64.77', 'spread': '9.536', 'groupId': 'BG000'}, {'value': '63.59', 'spread': '13.256', 'groupId': 'BG001'}, {'value': '64.14', 'spread': '11.506', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI (kg/m2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.020', 'spread': '3.1754', 'groupId': 'BG000'}, {'value': '24.229', 'spread': '4.6732', 'groupId': 'BG001'}, {'value': '24.130', 'spread': '3.9823', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Primary Lesion', 'classes': [{'title': 'Skin and soft tissue infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Primary blood stream infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Native osteoarticular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Intravenous line related', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Pleuropulmonary infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Device related', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Infective endocarditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Multiple counts are possible.', 'unitOfMeasure': 'Participants'}, {'title': 'Primary lesion removable', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary lesion removed', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "If the primary lesion removable is 'Yes'"}, {'title': 'Vancomycin MIC', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}], 'categories': [{'title': '<1.5 mcg/mL', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '≥1.5 mcg/mL', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Evaluation of the MIC (Minimum Inhibitory Concentration) of vancomycin was performed the time of screening when deemed necessary by the investigator, based on the MIC assessment method established at the site to confirm susceptibility, determine resistance to MRSA, and adjust the vancomycin dose.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Set (SS)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-07', 'size': 1345750, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-11T00:11', 'hasProtocol': True}, {'date': '2024-07-04', 'size': 599278, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-11T00:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind with placebo'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Placebo-controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'whyStopped': 'Early termination; Difficulties in enrolling subjects due to the decrease in patients with MRSA bacteremia', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2022-01-26', 'resultsFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2022-01-26', 'lastUpdatePostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-17', 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Vancomycin MIC Level', 'timeFrame': 'at Screening visit (baseline)', 'description': 'Vancomycin minimum inhibitory concentration (MIC) levels'}, {'measure': 'Delpazolid MIC Levels', 'timeFrame': 'Screening (Baseline), Day 14, EOT', 'description': 'Delpazolid minimum inhibitory concentration (MIC) level by broth microdilution (BMD)'}, {'measure': 'Pharmacokinetics (PK) parameters_AUC,ss', 'timeFrame': 'Plasma samples for pharmacokinetic evaluation were collected once at each timepoint on Day 1 and between Day 3 and end of treatment (EOT), specifically at 30 minutes to 1 hour and 2 to 8 hours after administration of the investigational product.', 'description': 'Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model.\n\n(AUC,ss: Area under the concentration-time curve at steady state)'}, {'measure': 'Pharmacokinetics (PK) parameters_Cmax,ss', 'timeFrame': 'Plasma samples for pharmacokinetic evaluation were collected once at each timepoint on Day 1 and between Day 3 and end of treatment (EOT), specifically at 30 minutes to 1 hour and 2 to 8 hours after administration of the investigational product.', 'description': 'Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model.\n\n(Cmax,ss: Maximum concentration of drug at steady state)'}, {'measure': 'Pharmacokinetics (PK) parameters_Cmin,ss', 'timeFrame': 'Plasma samples for pharmacokinetic evaluation were collected once at each timepoint on Day 1 and between Day 3 and end of treatment (EOT), specifically at 30 minutes to 1 hour and 2 to 8 hours after administration of the investigational product.', 'description': 'Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model.\n\n(Cmin,ss: Minimum concentration of drug at steady state)'}, {'measure': 'Pharmacokinetics (PK) parameters_Tmax,ss', 'timeFrame': 'Plasma samples for pharmacokinetic evaluation were collected once at each timepoint on Day 1 and between Day 3 and end of treatment (EOT), specifically at 30 minutes to 1 hour and 2 to 8 hours after administration of the investigational product.', 'description': 'Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model.\n\n(Tmax,ss: Time to reach Cmax at steady state)'}, {'measure': 'Pharmacokinetics (PK) parameters_t1/2β', 'timeFrame': 'Plasma samples for pharmacokinetic evaluation were collected once at each timepoint on Day 1 and between Day 3 and end of treatment (EOT), specifically at 30 minutes to 1 hour and 2 to 8 hours after administration of the investigational product.', 'description': 'Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model.\n\n(t1/2β : Terminal elimination half-life)'}, {'measure': 'Pharmacokinetics (PK) parameters_MRT,ss', 'timeFrame': 'Plasma samples for pharmacokinetic evaluation were collected once at each timepoint on Day 1 and between Day 3 and end of treatment (EOT), specifically at 30 minutes to 1 hour and 2 to 8 hours after administration of the investigational product.', 'description': 'Plasma LCB01-0371 concentration data in MRSA bacteremia patients were used to establish a pharmacokinetic model using NONMEM®. A two-compartment model, in which the Hemodialysis (HD) status and albumin as a covariate, was selected as the final model.\n\n(MRT,ss: Mean residence time at steady state)'}], 'primaryOutcomes': [{'measure': 'Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_FAS', 'timeFrame': 'at Day 14', 'description': "* 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'.\n* Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100"}, {'measure': 'Overall Cure Rate at Day 14 After the Start of Treatment (Composite Response Rate: Clinical Improvement Plus Clearance of Bacteremia)_PPS', 'timeFrame': 'at Day 14', 'description': "* 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'.\n* Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100"}], 'secondaryOutcomes': [{'measure': 'Overall Cure Rate by End of Treatment (EOT)_FAS', 'timeFrame': 'Day 7 visit and EOT (up to 6 weeks) visit', 'description': "* 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'.\n* Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100"}, {'measure': 'Overall Cure Rate by End of Treatment (EOT)_PPS', 'timeFrame': 'Day 7 visit and EOT (up to 6 weeks) visit', 'description': "* 'Overall cure' means that there are no symptoms of infection that existed when enrolled in the clinical trial, there are no new metastatic infection due to MRSA and no new infection (clinical improvement), and MRSA negative is confirmed twice in a row as a result of blood culture tests (clearance of bacteremia). If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as 'clearance of bacteremia'.\n* Composite Response rate = (number of participants showing overall cure at Day 14/number of participants in each treatment group) x 100"}, {'measure': 'Mortality From MRSA Bacteremia by EOT_FAS', 'timeFrame': 'During the treatment period (from the first administration to EOT (up to 6 weeks))', 'description': '* Proportion of participants who died due to MRSA bacteremia\n* Overall mortality = (number of participants who died/number of participants in each treatment group) x 100'}, {'measure': 'Mortality From MRSA Bacteremia by EOT_PPS', 'timeFrame': 'During the treatment period (from the first administration to EOT (up to 6 weeks))', 'description': '* Proportion of participants who died due to MRSA bacteremia\n* Overall mortality = (number of participants who died/number of participants in each treatment group) x 100'}, {'measure': 'Relapse Rate of MRSA bacteremia_FAS', 'timeFrame': 'from the first administration to TOC (4 weeks after EOT)', 'description': '* Defined as a positive blood culture to MRSA when previous ones were negative\n* Relapse rate of MRSA bacteremia = (number of participants with Relapse of MRSA bacteremia after clearance of MRSA bacteremia until TOC visit/number of participants with clearance of MRSA bacteremia in each treatment group) x 100'}, {'measure': 'Relapse Rate of MRSA bacteremia_PPS', 'timeFrame': 'from the first administration to TOC (4 weeks after EOT)', 'description': '* Defined as a positive blood culture to MRSA when previous ones were negative\n* Relapse rate of MRSA bacteremia = (number of participants with Relapse of MRSA bacteremia after clearance of MRSA bacteremia until TOC visit/number of participants with clearance of MRSA bacteremia in each treatment group) x 100'}, {'measure': 'Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_FAS', 'timeFrame': 'Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)', 'description': '* Proportion of participants who confirmed MRSA negative two consecutive set in the blood culture test\n* Clearance Rate = (number of subjects who achieved clearance at each visit/number of subjects in each treatment group) x 100'}, {'measure': 'Clearance Rate of MRSA Bacteremia at Day 3, Day 5, Day 7, Day 14, EOT_PPS', 'timeFrame': 'Day 3, Day 5, Day 7, Day 14, EOT (up to 6 weeks)', 'description': '* Proportion of participants who confirmed MRSA negative two consecutive set in the blood culture test\n* Clearance Rate = (number of subjects who achieved clearance at each visit/number of subjects in each treatment group) x 100'}, {'measure': 'Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_FAS', 'timeFrame': 'Day 3, Day 5, Day 7, Day 14', 'description': '* Proportion of participants who have positive results on blood culture tests\n* Persistent rate of bacteremia = (number of subjects who showing persistent bacteremia up to each visit /number of subjects in each treatment group up to each visit) x 100'}, {'measure': 'Persistent Rate of Bacteremia at Day 3, Day 5, Day 7, Day 14_PPS', 'timeFrame': 'Day 3, Day 5, Day 7, Day 14', 'description': '* Proportion of participants who have positive results on blood culture tests\n* Persistent rate of bacteremia = (number of subjects who showing persistent bacteremia up to each visit /number of subjects in each treatment group up to each visit) x 100'}, {'measure': 'Time to Clearance of MRSA bacteremia_FAS', 'timeFrame': 'by EOT (up to 6 weeks)', 'description': 'If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as clearance of bacteremia. The period until the clearance of bacteremia is defined as the period (day) from the date of the first blood culture test within 72 hours prior to randomization with MRSA positive (index blood culture) to the date of the blood culture test with the first negative result confirmed.'}, {'measure': 'Time to Clearance of MRSA bacteremia_PPS', 'timeFrame': 'by EOT (up to 6 weeks)', 'description': 'If negative in the blood culture test is confirmed for the first time, additional test will be performed the next day, and if it results negative for a total of two times in a row, it is judged as clearance of bacteremia. The period until the clearance of bacteremia is defined as the period (day) from the date of the first blood culture test within 72 hours prior to randomization with MRSA positive (index blood culture) to the date of the blood culture test with the first negative result confirmed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRSA', 'Staphylococcus aureus bacteremia', 'SAB', 'bloodstream infection', 'BSI', 'Bacteremia'], 'conditions': ['MRSA Bacteremia']}, 'descriptionModule': {'briefSummary': 'The objectives of this study is to exploratory whether Vancomycin + Delpazolid is more effective to the standard of treatment (Vancomycin)/ for hospitalized adults with MRSA bacteraemia.', 'detailedDescription': 'The mortality from S aureus bacteremia is higher for MRSA than for methicillin-susceptible S aureus (MSSA), typically at 20% to 25%.\n\nThe current standard therapy for MRSA bacteremia is Vancomycin. Vancomycin has many shortcomings, including poor tissue penetration and slow killing time. Vancomycin has reduced efficacy against MRSA and tended to increase the MIC level (called MIC creep). Addition of Delpazolid to Vancomycin could improve the known drawbacks of Vancomycin alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female ≥19 years of age on the date of written consent\n* Subject who has confirmed positive MRSA at least one set of blood cultures within 72 hours prior to randomization OR, Subject who has confirmed positive MRSA at least one set of blood culture whthin 96 hours prior to randomization and treated with vancomycin at least 72 hours prior to randomization\n* Subject who has clinical symptoms or signs of MRSA bacteremia according to the judgment of the investigator\n* Subject who voluntarily decides to participate in this clinical trial after being explained fully, and agrees in writing to implement the clinical trial compliance matters\n\nExclusion Criteria:\n\n* Subject with polymicrobial bacteremia or infections including Gram-negative strain\n* Subject undergoing or in need of treatment with antiviral or antifungal drugs\n* Subject who has received treatment for MRSA bacteremia within 3 months of screening (Subjects who have "re-infection" by investigator\'s judgement may participant in the study.)\n* Subject who has been administered effective antibiotics against MRSA (Vancomycin, etc.) for more than 96 hours prior to the first investigational product administration. (However, antibiotics effective for MRSA such as vancomycin are allowed to be administered for less than 72 hours.)\n* Septic shock patients\n* Subject who has hypersensitivity to vancomycin or linezolid\n* Subject who has a history of hypersensitivity to peptide-based antibiotics and aminoglycoside-based antibiotics\n* Subject who is receiving a MAO inhibitor(MAOI) or has received MAOI within 14 days of the first investigational drug administration\n* Subject taking serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptan), meperidine, or buspirone\n* Subject with severely decreased immunity (Severe neutropenia (ANC \\<0.5×10\\^9/L) etc.)\n* Subject who is expected to die within 2 days due to serious complications of MRSA bacteremia based on the judgment of the investigator\n* Body Mass Index (BMI) ≥35 kg/m2\n* Subject who is unable to administer drugs orally\n* Pregnant or lactating female, female or male with childbearing potential who disagrees with the use of appropriate contraceptive methods during the study and up to 14 days after the last dose of the investigator product\n* Subject who has received other clinical trial drugs within 30 days of screening\n* Subject who is not suitable for participation in this clinical trial according to the medical findings of investigators'}, 'identificationModule': {'nctId': 'NCT05225558', 'briefTitle': 'A Phase 2a Study, Effect of Vancomycin With vs Without Delpazolid (LCB01-0371) in Patients With MRSA Bacteremia', 'organization': {'class': 'INDUSTRY', 'fullName': 'LigaChem Biosciences, Inc.'}, 'officialTitle': 'A Multicenter, Double-blinded, Randomized, Parallel Design, Phase IIa Clinical Trial to Evaluate the Efficacy, Safety and PK of LCB01-0371 With Vancomycin Versus Vancomycin Monotherapy in Patients With MRSA Bacteremia', 'orgStudyIdInfo': {'id': 'LCB35-0371-21-2-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination therapy - Vancomycin (IV) plus Delpazolid (PO)', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nDelpazolid: 800 mg, BID, PO", 'interventionNames': ['Drug: Delpazolid', 'Drug: Vancomycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Monotherapy - Vancomycin (IV) plus Placebo of Delpazolid (PO)', 'description': "Vancomycin: IV infusion per 2020 IDSA guideline\n\n* Intravenous Vancomycin dosed as per 2020 IDSA guideline\n* Doses of 15 to 20 mg/kg (based on actual body weight) administered every 8 to 12 hours as an intermittent infusion were recommended for most patients with normal renal function when assuming a MICBMD of 1 mg/L.\n* Depending on the investigator's judgment, it was allowed to change to Daptomycin after at least one week of administration of Vancomycin, and also it was allowed to change to oral antibiotics other than oxazolidinones after two weeks of administration of Vancomycin (including Daptomycin).\n\nPlacebo of Delpazolid: BID, PO", 'interventionNames': ['Drug: Vancomycin', 'Drug: Placebo of Delpazolid']}], 'interventions': [{'name': 'Delpazolid', 'type': 'DRUG', 'otherNames': ['LCB01-0371'], 'description': 'BID, PO', 'armGroupLabels': ['Combination therapy - Vancomycin (IV) plus Delpazolid (PO)']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': 'IV infusion per 2020 IDSA guideline', 'armGroupLabels': ['Combination therapy - Vancomycin (IV) plus Delpazolid (PO)', 'Monotherapy - Vancomycin (IV) plus Placebo of Delpazolid (PO)']}, {'name': 'Placebo of Delpazolid', 'type': 'DRUG', 'otherNames': ['Placebo of LCB01-0371'], 'description': 'BID, PO', 'armGroupLabels': ['Monotherapy - Vancomycin (IV) plus Placebo of Delpazolid (PO)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61453', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '61469', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '13620', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '15355', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hongbin Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'IPD will be provided 1-2 years after and up to 5 years after the publication of the article on the results of the trial.', 'ipdSharing': 'YES', 'description': 'Deidentified individual patient data, that underlie the results in published article(s) based on data from the trial which including text, tables, figures will be presented to various stakeholders. This reported will be presented to various stakeholder during various forums or meetings. First results will be disclosed to participants, staff and our site Community Advisory Board. Thereafter we would invite several stakeholders from the community or visit their establishments to review study results. Simultaneously, the studying findings report will be sent to the various regulatory authorities, including the National Department of Health (NDoH). With NDoH and its divisions we will establish needs for further engagement and suggestions for policy or programmatic changes.', 'accessCriteria': 'IPD access will be provided for analyses of the related to the aims of research described in the protocol and for individual patient data meta analyses to researches who provide a methodologically sound proposal to lcb\\_pv@legochembio.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LigaChem Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}