Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-01 @ 1:46 PM
Study NCT ID:
NCT03138733
Status:
COMPLETED
Last Update Posted:
2023-11-08
First Post:
2017-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Hungary', 'Peru', 'Portugal'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505439', 'term': 'ceftobiprole medocaril'}, {'id': 'D017576', 'term': 'Daptomycin'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marc.engelhardt@basilea.com', 'phone': '+41 79 701 0551', 'title': 'Dr Marc Engelhardt, MD', 'organization': 'Basilea Pharmaceutica'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs occurring from the start of first dosing up to and including the scheduled PTE visit on Day 70 (± 5 days) were collected.', 'description': 'All AEs were defined as treatment-emergent AEs (TEAEs), i.e., occurring from the start of first dosing up to and including the scheduled PTE visit, and were considered for the analysis purpose.', 'eventGroups': [{'id': 'EG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion', 'otherNumAtRisk': 191, 'deathsNumAtRisk': 191, 'otherNumAffected': 61, 'seriousNumAtRisk': 191, 'deathsNumAffected': 17, 'seriousNumAffected': 36}, {'id': 'EG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 45, 'seriousNumAtRisk': 198, 'deathsNumAffected': 18, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'Wound healing normal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intracardiac mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypocoagulable state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eosinophilic pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eosinophilic pneumonia acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intra-abdominal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Oesophageal varices haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pancreatic haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pancreatitis necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Retroperitoneal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cutaneous vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pemphigoid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Candida sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Endocarditis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haematoma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infectious pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Mediastinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscle abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Purulent pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Septic necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Superinfection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Haemodialysis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Kidney rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Chloroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'OG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}], 'classes': [{'title': 'Number of responders', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}]}, {'title': 'Number of non-responders', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted proportion difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '11.1', 'groupDescription': 'The observed difference in percentage of responders at PTE (ceftobiprole group minus the daptomycin group) were determined and a two-sided 95% confidence interval (CI) for the observed difference was computed, with adjustment for actual stratum (dialysis status and prior antibacterial treatment use). Cochran-Mantel-Haenszel (CMH) weights were used for the stratum weight in the calculation of the CI', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority hypothesis test was a one-sided hypothesis test performed at the 2.5% level of significance. If the lower limit of the two sided 95% CI for the difference in response rates in the mITT population was greater than -15%, the non-inferiority of ceftobiprole to daptomycin therapy was to be concluded.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'PTE visit on Day 70 (± 5 days) post-randomization', 'description': 'Comparison of overall success rates in the mITT population\n\nOverall success at PTE for the mITT population was defined as all of the following criteria being met (Responder):\n\n1. Patient alive at Day 70 (± 5 days) post-randomization.\n2. No new metastatic foci or complications of the SAB infection.\n3. Resolution or improvement of SAB-related clinical signs and symptoms.\n4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline'}, {'type': 'SECONDARY', 'title': 'Number of Patients With or Without Overall Success at the PTE Visit in the CE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'OG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}], 'classes': [{'title': 'Number of responders', 'categories': [{'measurements': [{'value': '127', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Number of non-responders', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted proportion difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '9.5', 'estimateComment': 'The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At PTE visit on Day 70 (± 5 days) post-randomization', 'description': 'Comparison of overall success rates in the Clinical Evaluable (CE) population\n\nOverall success at PTE for the CE population was defined as all of the following criteria being met (Responder):\n\n1. Patient alive at Day 70 (± 5 days) post-randomization.\n2. No new metastatic foci or complications of the SAB infection.\n3. Resolution or improvement of SAB-related clinical signs and symptoms.\n4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The CE population comprised the subset of patients in the mITT population who complied with important pre-specified aspects of the study'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Microbiological Eradication at the PTE Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'OG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}], 'classes': [{'categories': [{'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted proportion difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '13', 'estimateComment': 'The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At PTE visit on Day 70 (± 5 days) post-randomization', 'description': 'Comparison of microbiological eradication rates in the mITT population. Microbiological eradication rate was defined as a negative blood culture for S. aureus during study treatment and another negative blood culture during the follow up period up to PTE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality at the PTE Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'OG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}], 'classes': [{'title': 'Patients died', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Patients alive', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted proportion difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '5.2', 'estimateComment': 'The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At PTE visit on Day 70 (± 5 days) post-randomization', 'description': 'Comparison of all-cause mortality rates in the mITT population', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline'}, {'type': 'SECONDARY', 'title': 'Number of Patients With or Without New Metastatic Foci or Other Complications of SAB Developed After Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'OG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}], 'classes': [{'categories': [{'title': 'Patients with development of new metastatic foci or other complications of SAB after Day 7', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Patients without development of new metastatic foci or other complications of SAB after Day 7', 'measurements': [{'value': '178', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted proportion difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '4.8', 'estimateComment': 'The two-sided 95% CI was computed using Cochran-Mantel-Haenszel (CMH) weights method adjusted for actual stratum (dialysis status and prior antibacterial treatment use)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessment after Day 7 post-randomization through to post-treatment evaluation (PTE) visit on Day 70 (± 5 days)', 'description': 'Comparison of complication rates in the mITT population defined by number of patients with development of new metastatic foci or other complications of SAB after Day 7', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline'}, {'type': 'SECONDARY', 'title': 'Time to Staphylococcus Aureus Bloodstream Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'OG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 6 weeks post-randomization', 'description': 'Time-to-event in the mITT Bloodstream clearance was defined as two consecutive study days with blood-culture-negative assessments for S. aureus, without any subsequent S. aureus relapse or reinfection', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population comprised the subset of patients in the ITT population who received any dose of study medication, and had a blood culture positive for S. aureus at baseline'}, {'type': 'SECONDARY', 'title': 'Number of Patients With or Without Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'OG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}], 'classes': [{'title': 'Any adverse events (AEs)', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}, {'title': 'Any drug-related AE', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Any severe AEs', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Any study drug-related severe AEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Any serious adverse events (SAE)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Any drug-related SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Any AE leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Study drug-related AEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Any AE leading to death', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Study drug-related AEs leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Any AE of special interest (AESI)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Any drug-related AESI', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'AEs were assessed from the first dose of study drug through the post-treatment evaluation (PTE) visit on Day 70 (± 5 days)', 'description': 'Treatment-emergent adverse events in the safety population', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population comprised all randomized patients who received any dose of study drug. Patients in the Safety population were analyzed according to the first study drug received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'FG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Intent-to-Treat (ITT) population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '192'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'Modified ITT (mITT)', 'comment': 'Three patients were excluded from the mITT population in the ceftobiprole group: one patient discontinued prior to receiving study treatment, and two patients were determined by central laboratory results not to have a confirmed positive blood culture for Staphylococcus aureus at baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '157'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '29'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Administrative or logistical reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'The patient was transferred to another hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Hospitalized male or female patients aged ≥ 18 years who had complicated Staphylococcus aureus bacteremia (SAB).\n\nSAB, based on ≥ 1 positive blood culture obtained within 72 h prior to randomization, with signs or symptoms of bloodstream infection', 'preAssignmentDetails': 'A total of 390 patients were randomized and comprised the Intent-to-Treat (ITT) population (ceftobiprole n = 192; comparator n = 198). Three of these patients were excluded from the modified ITT (mITT) population: one patient in the ceftobiprole group who discontinued prior to receiving study treatment, and two patients in the ceftobiprole group who were determined by central laboratory results not to have a confirmed positive blood culture for Staphylococcus aureus at baseline'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ceftobiprole', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)\n\nCeftobiprole: Ceftobiprole 500 mg as a 2 h infusion'}, {'id': 'BG001', 'title': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg, with or without aztreonam\n\nDaptomycin: Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'spread': '15.18', 'groupId': 'BG000'}, {'value': '56.5', 'spread': '15.33', 'groupId': 'BG001'}, {'value': '56.0', 'spread': '15.25', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '182', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '179', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '371', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Europe', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}]}, {'title': 'North America', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Central America', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'South America', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Aztreonam treatment at baseline', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Most frequent baseline categories of complicated SAB (Investigator-assessed)', 'classes': [{'title': 'Skin and skin structure infection', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}, {'title': 'Intra-abdominal abscess', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Chronic dialysis', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Septic arthritis', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Persistent SAB', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Osteomyelitis', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Definite right-sided endocarditis', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The mITT (Intent-to-Treat population who received any dose of study medication) and who had a blood culture positive for staphylococcus aureus represented the Baseline Analysis Population. It comprised 387 out of the 390 patients in the ITT population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-27', 'size': 893179, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-17T11:49', 'hasProtocol': True}, {'date': '2022-06-17', 'size': 2762653, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-21T06:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2017-04-27', 'resultsFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2017-04-29', 'lastUpdatePostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-12', 'studyFirstPostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With or Without Overall Success at the Post-treatment Evaluation (PTE) Visit', 'timeFrame': 'PTE visit on Day 70 (± 5 days) post-randomization', 'description': 'Comparison of overall success rates in the mITT population\n\nOverall success at PTE for the mITT population was defined as all of the following criteria being met (Responder):\n\n1. Patient alive at Day 70 (± 5 days) post-randomization.\n2. No new metastatic foci or complications of the SAB infection.\n3. Resolution or improvement of SAB-related clinical signs and symptoms.\n4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With or Without Overall Success at the PTE Visit in the CE Population', 'timeFrame': 'At PTE visit on Day 70 (± 5 days) post-randomization', 'description': 'Comparison of overall success rates in the Clinical Evaluable (CE) population\n\nOverall success at PTE for the CE population was defined as all of the following criteria being met (Responder):\n\n1. Patient alive at Day 70 (± 5 days) post-randomization.\n2. No new metastatic foci or complications of the SAB infection.\n3. Resolution or improvement of SAB-related clinical signs and symptoms.\n4. Two negative blood cultures for S. aureus (without any subsequent positive blood culture for S. aureus)'}, {'measure': 'Number of Patients With Microbiological Eradication at the PTE Visit', 'timeFrame': 'At PTE visit on Day 70 (± 5 days) post-randomization', 'description': 'Comparison of microbiological eradication rates in the mITT population. Microbiological eradication rate was defined as a negative blood culture for S. aureus during study treatment and another negative blood culture during the follow up period up to PTE.'}, {'measure': 'All-cause Mortality at the PTE Visit', 'timeFrame': 'At PTE visit on Day 70 (± 5 days) post-randomization', 'description': 'Comparison of all-cause mortality rates in the mITT population'}, {'measure': 'Number of Patients With or Without New Metastatic Foci or Other Complications of SAB Developed After Day 7', 'timeFrame': 'Assessment after Day 7 post-randomization through to post-treatment evaluation (PTE) visit on Day 70 (± 5 days)', 'description': 'Comparison of complication rates in the mITT population defined by number of patients with development of new metastatic foci or other complications of SAB after Day 7'}, {'measure': 'Time to Staphylococcus Aureus Bloodstream Clearance', 'timeFrame': 'Up to 6 weeks post-randomization', 'description': 'Time-to-event in the mITT Bloodstream clearance was defined as two consecutive study days with blood-culture-negative assessments for S. aureus, without any subsequent S. aureus relapse or reinfection'}, {'measure': 'Number of Patients With or Without Adverse Events (AEs)', 'timeFrame': 'AEs were assessed from the first dose of study drug through the post-treatment evaluation (PTE) visit on Day 70 (± 5 days)', 'description': 'Treatment-emergent adverse events in the safety population'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ceftobiprole, daptomycin, Staphylococcus aureus', 'Bacteremia, bloodstream infection'], 'conditions': ['Staphylococcus Aureus Bacteremia']}, 'referencesModule': {'references': [{'pmid': '31918579', 'type': 'BACKGROUND', 'citation': 'Hamed K, Engelhardt M, Jones ME, Saulay M, Holland TL, Seifert H, Fowler VG Jr. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiol. 2020 Jan;15(1):35-48. doi: 10.2217/fmb-2019-0332. Epub 2020 Jan 10.'}, {'pmid': '37754204', 'type': 'RESULT', 'citation': 'Holland TL, Cosgrove SE, Doernberg SB, Jenkins TC, Turner NA, Boucher HW, Pavlov O, Titov I, Kosulnykov S, Atanasov B, Poromanski I, Makhviladze M, Anderzhanova A, Stryjewski ME, Assadi Gehr M, Engelhardt M, Hamed K, Ionescu D, Jones M, Saulay M, Smart J, Seifert H, Fowler VG Jr; ERADICATE Study Group. Ceftobiprole for Treatment of Complicated Staphylococcus aureus Bacteremia. N Engl J Med. 2023 Oct 12;389(15):1390-1401. doi: 10.1056/NEJMoa2300220. Epub 2023 Sep 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB).', 'detailedDescription': 'Patients were randomized 1:1 to ceftobiprole or the comparator regimen. Randomization was stratified by study site, dialysis status, and prior antibacterial treatment use within 7 days before randomization.\n\nThe three phases of the study were:\n\n1. Screening assessments of up to 72 hours prior to randomization\n2. Randomization and subsequent active treatment with intravenous (i.v.) study drug (ceftobiprole or daptomycin ± aztreonam).\n3. Post-treatment, comprising an end of trial (EOT) visit (within 72 hours of last study-drug administration), Day 35 (± 3 days), Day 42 (± 3 days), and a post-treatment evaluation (PTE) visit on Day 70 (± 5 days) post-randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female ≥ 18 years of age\n* Staphylococcus aureus bacteremia (SAB), based on at least one positive blood culture obtained within the 72 h prior to randomization\n* At least one of the following signs or symptoms of bacteremia:\n\n 1. fever (e.g.≥ 38 °C/100.4 °F measured orally)\n 2. white blood cell count \\> 10,000 or \\< 4,000 cells/µL, or \\> 10% immature neutrophils (bands)\n 3. tachycardia (heart rate \\> 90 bpm)\n 4. hypotension (systolic blood pressure \\< 90 mmHg)\n* At least one of the following:\n\n 1. SAB in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis\n 2. Persistent SAB\n 3. Definite native-valve right-sided infective endocarditis by Modified Duke's Criteria\n 4. Other forms of complicated SAB\n 5. Osteomyelitis (including vertebral, sternal, or long-bone osteomyelitis)\n 6. Epidural or cerebral abscess\n* Other inclusion criteria have been applied\n\nExclusion Criteria:\n\n* Treatment with potentially effective (anti-staphylococcal) systemic antibacterial treatment for more than 48 h within the 7 days prior to randomization; Exception: Documented failure of bloodstream clearance\n* Bloodstream or non-bloodstream concomitant infections with Gram-negative bacteria that are known to be non-susceptible to either ceftobiprole or aztreonam\n* Left-sided infective endocarditis\n* Prosthetic cardiac valves or valve support rings, cardiac pacemakers, automatic implantable cardioverter-defibrillator, or left-ventricular assist devices\n* Community- or hospital-acquired pneumonia\n* Opportunistic infections within 30 days prior to randomization, where the underlying cause of these infections is still active\n* Requirement for continuous renal-replacement therapy\n* Women who are pregnant or nursing\n* Other exclusion criteria have been applied"}, 'identificationModule': {'nctId': 'NCT03138733', 'briefTitle': 'Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basilea Pharmaceutica'}, 'officialTitle': 'A Randomized, Double-blind, Multi-center Study to Establish the Efficacy and Safety of Ceftobiprole Medocaril Compared to Daptomycin in the Treatment of Staphylococcus Aureus Bacteremia, Including Infective Endocarditis', 'orgStudyIdInfo': {'id': 'BPR-CS-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ceftobiprole medocaril', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril)', 'interventionNames': ['Drug: Ceftobiprole medocaril']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Daptomycin', 'description': 'Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards), with or without aztreonam', 'interventionNames': ['Drug: Daptomycin']}], 'interventions': [{'name': 'Ceftobiprole medocaril', 'type': 'DRUG', 'description': 'Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion', 'armGroupLabels': ['Ceftobiprole medocaril']}, {'name': 'Daptomycin', 'type': 'DRUG', 'description': 'Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam', 'armGroupLabels': ['Daptomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'eStudy Site - Chula Vista - PPDS', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Medical Services Inc', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical Group', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'eStudy Site - Las Vegas - PPDS', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Remington Davis Inc.', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '81641', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Central Hospital de San Isidro Melchor Posse', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1900AVG', 'city': 'La Plata', 'country': 'Argentina', 'facility': 'Medical Institute Platense SA', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'S2000CVB', 'city': 'Rosario', 'country': 'Argentina', 'facility': 'British Sanatorium SA', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': '4004', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Intensive Care Clinic', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': "University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of General, Purulent-Septic, Pediatric and One Day Surgery", 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '8800', 'city': 'Sliven', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Treatment "Dr. Ivan Seliminski", Sliven, Anesthesiology and Intensive Care Department', 'geoPoint': {'lat': 42.68607, 'lon': 26.32558}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. 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