Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT03583333
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2018-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 98 days', 'description': 'All-cause mortality: all randomized participants; Safety: all randomized participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'IMI/REL', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 138, 'otherNumAffected': 81, 'seriousNumAtRisk': 134, 'deathsNumAffected': 18, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'PIP/TAZ', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 66, 'seriousNumAtRisk': 136, 'deathsNumAffected': 11, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 27, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ventricular tachyarrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastropleural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anastomotic fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Traumatic intracranial haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lung squamous cell carcinoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Basal ganglia haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Brain oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Brain stem haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ruptured cerebral aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis exfoliative generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '5.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '12.4', 'estimateComment': 'Adjusted differences and the 95% confidence intervals (CIs) are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority margin for the difference in mortality (IMI/REL minus PIP/TAZ) was 12.5%.'}, {'pValue': '0.938', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '12.4', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted differences and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 28 days', 'description': 'For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.7', 'groupId': 'OG000'}, {'value': '47.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.1', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '14.9', 'estimateComment': 'Adjusted differences and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 27 days', 'description': 'Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'groupId': 'OG000'}, {'value': '62.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-12.4', 'ciUpperLimit': '16.8', 'estimateComment': 'Adjusted difference and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 27 days', 'description': 'Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain. The CE population was a subset of the MITT population who also met important diagnostic criteria for entry into the study, had no significant deviation from the protocol and received the minimum duration of IV study therapy. Only participants with non-missing/non-indeterminate response were assessed at EFU visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000'}, {'value': '68.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-7.6', 'ciUpperLimit': '14.3', 'estimateComment': 'Adjusted difference and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 14 days', 'description': 'Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy was required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000'}, {'value': '82.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.7', 'ciLowerLimit': '-15.8', 'ciUpperLimit': '6.6', 'estimateComment': 'Adjusted difference and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 14 days', 'description': 'Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy is required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population consisting of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci only on baseline Gram stain. The CE population was a subset of the MITT population who also met important diagnostic criteria for entry into the study, had no significant deviation from the protocol and received the minimum duration of IV study therapy. Only participants with non-missing/non-indeterminate response were assessed at EOT visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000'}, {'value': '60.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-17.8', 'ciUpperLimit': '13.1', 'estimateComment': 'Adjusted differences and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 14 days', 'description': 'Favorable overall microbiological response rates were defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MITT population consisted of all randomized participants who received at least 1 dose of IV study therapy and did not have the presence of positive cocci. The microbiological modified intention-to-treat (mMITT) population was a subset of the MITT population that possessed a baseline bacterial pathogen isolated from a lower respiratory tract (LRT) specimen that was identified as the cause of HABP/VABP and against which IMI/REL has been shown to have antibacterial activity.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000'}, {'value': '78.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '19.8', 'estimateComment': 'Adjusted difference and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 27 days', 'description': 'A favorable by-pathogen microbiological response at EFU visit required "eradication" (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants receiving ≥1 dose of IV study therapy without presence of positive cocci (MITT); who met important diagnostic criteria for study with no significant protocol deviation and received minimum duration of IV study therapy (CE); had a baseline bacterial pathogen cause of HABP/VABP against which IMI/REL has antibacterial activity and results from a lower respiratory tract culture obtained at indicated time point (ME); and had non-missing/non-indeterminate response at EFU.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000'}, {'value': '74.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-19.8', 'ciUpperLimit': '14.4', 'estimateComment': 'Adjusted difference and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 14 days', 'description': 'Favorable overall microbiological response rates was defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants receiving ≥1 dose of IV study therapy without presence of positive cocci (MITT); who met important diagnostic criteria for study with no significant protocol deviation and received minimum duration of IV study therapy (CE); had a baseline bacterial pathogen cause of HABP/VABP against which IMI/REL has antibacterial activity and results from a lower respiratory tract culture obtained at indicated time point (ME); and had non-missing/non-indeterminate response at EOT.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '86.6', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '10.6', 'estimateComment': 'Difference and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 98 days', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of IV study therapy were assessed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Discontinuing Study Drug Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'OG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000'}, {'value': '8.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted difference in percentage', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.4', 'ciLowerLimit': '-10.7', 'ciUpperLimit': '1.4', 'estimateComment': 'Difference and the 95% CIs are based on Miettinen \\& Nurminen method stratified by randomization stratum.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 14 days', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of IV study therapy were assessed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'FG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '136'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '106'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Participant Conducted Day 28 Visit Prior to the Required Time Window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Parent/Guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'This study was conducted at 54 centers in 8 countries.', 'preAssignmentDetails': 'Participants were randomized 1:1 to receive either FDC of imipenem/cilastatin (IMI) and relebactam (REL) \\[IMI/REL, MK-7655A\\], or piperacillin/tazobactam (PIP/TAZ).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) was administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) was ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'BG001', 'title': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ) was administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants were treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection continued to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.9', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '59.2', 'spread': '14.7', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Randomization strata: Pneumonia type at baseline', 'classes': [{'title': 'Non-ventilated HABP', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}, {'title': 'Ventilated HABP/VABP', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by the following two pneumonia types at baseline: Non-ventilated hospital acquired bacterial pneumonia (HABP) and ventilated HABP/ventilator associated bacterial pneumonia (VABP).', 'unitOfMeasure': 'Participants'}, {'title': 'Randomization strata: Acute Physiology and Chronic Health Evaluation (APACHE) II score at baseline', 'classes': [{'title': 'APACHE II Score <15', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}, {'title': 'APACHE II Score ≥15', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'APACHE score is a severity-of-disease classification system that is calculated from a participants age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death. Participants were stratified by APACHE II score at baseline \\<15 vs. \\>15', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-11', 'size': 3133039, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-06-27T09:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2018-06-28', 'resultsFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-27', 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population', 'timeFrame': 'Up to approximately 28 days', 'description': 'For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population', 'timeFrame': 'Up to approximately 27 days', 'description': 'Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented.'}, {'measure': 'Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population', 'timeFrame': 'Up to approximately 27 days', 'description': 'Clinical response was defined as "Sustained cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented.'}, {'measure': 'Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population', 'timeFrame': 'Up to approximately 14 days', 'description': 'Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy was required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented.'}, {'measure': 'Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population', 'timeFrame': 'Up to approximately 14 days', 'description': 'Clinical response was defined as "Improved" (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to "pre-infection status" AND no additional antibiotic therapy is required) or "Cure" (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented.'}, {'measure': 'Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population', 'timeFrame': 'Up to approximately 14 days', 'description': 'Favorable overall microbiological response rates were defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented.'}, {'measure': 'Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population.', 'timeFrame': 'Up to approximately 27 days', 'description': 'A favorable by-pathogen microbiological response at EFU visit required "eradication" (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented.'}, {'measure': 'Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population', 'timeFrame': 'Up to approximately 14 days', 'description': 'Favorable overall microbiological response rates was defined as "eradication" (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR "presumed eradication" (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented.'}, {'measure': 'Percentage of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'Up to approximately 98 days', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm.'}, {'measure': 'Percentage of Participants Discontinuing Study Drug Due to AEs', 'timeFrame': 'Up to approximately 14 days', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hospital-Acquired Bacterial Pneumonia', 'Ventilator-Associated Bacterial Pneumonia']}, 'referencesModule': {'references': [{'pmid': '39674398', 'type': 'RESULT', 'citation': 'Li J, Wei F, Xiang P, Tang Z, Ding L, Chen LF, Losada M, Iamboliyska Z, Sun F, Zhu M, Guo X, Du X, Chen C, Bruno C, Koseoglu S, Young K, Zhou M, Qu J. A phase III, randomized, controlled noninferiority trial to study the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) vs piperacillin/tazobactam (PIP/TAZ) in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Int J Infect Dis. 2025 Apr;153:107357. doi: 10.1016/j.ijid.2024.107357. Epub 2024 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) \\[IMI/REL, MK-7655A\\] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Requires treatment with IV antibiotic therapy for HABP or VABP\n* Fulfills clinical and radiographic criteria within 48 hours prior to randomization, with onset of criteria occurring after more than 2 days of hospitalization or within 7 days after discharge from a hospital for HABP; or at least 2 days after mechanical ventilation (for VABP)\n* Has an adequate baseline (at or within 2 days of screening) lower respiratory tract specimen obtained for Gram stain and culture\n* Has an infection known or thought to be, in the opinion of the investigator, caused by microorganisms susceptible to the IV study therapy\n* Agrees to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided to the Central Microbiology Reference Laboratory for study-related microbiological testing and long-term storage\n* Males agree to use contraception as detailed in protocol from the time of providing informed consent through completion of the study and refrain from donating sperm during this period\n* Females are not pregnant, not breastfeeding, and are either: a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow the contraceptive guidance from the time of providing informed consent through completion of the study\n* If a penicillin skin test is required by local clinical practice, the participant must have a negative skin test result for allergy to penicillin\n\nExclusion Criteria:\n\n* Has a baseline lower respiratory tract specimen Gram stain that shows the presence of Gram-positive cocci only\n* Has confirmed or suspected community-acquired bacterial pneumonia (CABP)\n* Has confirmed or suspected pneumonia caused by Mycoplasma, Chlamydia, or Legionella, or of viral, fungal, or parasitic etiology\n* Has HABP/VABP caused by an obstructive process, including lung cancer (or other malignancy metastatic to the lungs resulting in pulmonary obstruction) or other known obstruction\n* Has a carcinoid tumor or carcinoid syndrome\n* Has active immunosuppression\n* Is expected to die during the 7- to 14-day treatment period, despite adequate antibiotic therapy\n* Has a concurrent condition or infection that, in the investigator's judgment, would preclude evaluation of therapeutic response\n* Has a history of serious allergy, hypersensitivity, or any serious reaction to any β-lactams or β-lactamase inhibitors\n* Has a history of a seizure disorder which has required ongoing treatment with anticonvulsive therapy or prior treatment with anti-convulsive therapy within the last 3 years\n* Is currently undergoing hemodialysis or peritoneal dialysis\n* A WOCBP who has a positive urine pregnancy test at screening\n* Has received effective antibacterial drug therapy with known coverage of pathogens that cause HABP/VABP for a continuous duration of more than 48 hours during the previous 72 hours\n* Is anticipated to be treated with any of the prohibited medications during the course of study therapy\n* Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 90 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial\n* Has previously participated in this study at any time"}, 'identificationModule': {'nctId': 'NCT03583333', 'briefTitle': 'Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multi-national Phase 3, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety, Tolerability, and Efficacy of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Subjects With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia', 'orgStudyIdInfo': {'id': '7655A-016'}, 'secondaryIdInfos': [{'id': 'MK-7655A-016', 'type': 'OTHER', 'domain': 'MSD Protocol Number'}, {'id': 'PHRR190814-002177', 'type': 'REGISTRY', 'domain': 'PHRR'}, {'id': '2018-003202-82', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMI/REL FDC', 'description': 'Imipenem/cilastatin/relebactam (IMI/REL) administered intravenously (IV) as a fixed-dose combination (FDC) at a dosage of 500 mg IMI/250 mg REL, once every 6 hours for a minimum 7 days, up to 14 days. At the start of IMI/REL treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.', 'interventionNames': ['Drug: IMI/REL FDC', 'Drug: Linezolid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PIP/TAZ FDC', 'description': 'Piperacillin/tazobactam (PIP/TAZ ) administered IV as a FDC at a dosage of 4000 mg PIP/500 mg TAZ once every 6 hours for a minimum 7 days, up to 14 days. At the start of PIP/TAZ treatment, participants will be treated empirically with 600 mg open-label linezolid administered IV every 12 hours until methicillin-resistant Staphylococcus aureus (MRSA) is ruled out. Participants with confirmed MRSA infection will continue to receive 600 mg linezolid every 12 hours for a minimum of 7 days, up to 14 days total.', 'interventionNames': ['Drug: PIP/TAZ FDC', 'Drug: Linezolid']}], 'interventions': [{'name': 'IMI/REL FDC', 'type': 'DRUG', 'otherNames': ['MK-7655A'], 'description': '500 mg Imipenem, 500 mg Cilastatin and 250 mg Relebactam powder FDC provided in a single vial', 'armGroupLabels': ['IMI/REL FDC']}, {'name': 'PIP/TAZ FDC', 'type': 'DRUG', 'description': '4000 mg Piperacillin and 500 mg Tazobactam powder FDC provided in a single vial', 'armGroupLabels': ['PIP/TAZ FDC']}, {'name': 'Linezolid', 'type': 'DRUG', 'description': 'Open-label 600 mg Linezolid', 'armGroupLabels': ['IMI/REL FDC', 'PIP/TAZ FDC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30150-221', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Santa Casa de Misericordia de Belo Horizonte ( Site 0300)', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '15090-000', 'city': 'Sao Jose Do Rio Preto - SP', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital de Base de Sao Jose de Rio Preto ( Site 0301)'}, {'zip': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Chaoyang Hospital ( Site 0126)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital ( Site 0131)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100049', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Aero Space center hospital ( Site 0118)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100073', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The Seventh Medical Center of PLA General Hospital-Intensive medicine ( Site 0157)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospital ( Site 0115)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital ( Site 0127)', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'The First Affiliated Hospital Of Fujian Medical University-Respiratory ( Site 0136)', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '361004', 'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhongshan Hospital Affiliated to Xiamen University ( Site 0133)', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '363000', 'city': 'Zhangzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Zhangzhou Municipal Hospital of Fujian Province-Neurosurgery Department ( 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