At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 390 enrolled
Drug / intervention
Ceftobiprole medocaril +1 moredrug
Likely dose
Ceftobiprole medocaril 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Ceftobiprole medocaril and Daptomycin for Staphylococcus Aureus Bacteremia. Completed, enrolled 390 participants across 60 sites in 17 countries.
Detailed Summary
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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStaphylococcus Aureus Bacteremia
CountriesArgentina, Bulgaria, Colombia, Georgia, Germany, Greece, Israel, Italy, Mexico, Panama, Russia, Serbia, South Africa, Spain, Turkey (Türkiye), Ukraine, United States
CollaboratorsDepartment of Health and Human Services
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedMay 2017
Enrollment StartAug 2018
Primary CompletionMar 2022
TodayJul 2026
First PostedMay 3, 2017
Enrollment StartAug 26, 2018
Primary CompletionMar 11, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 9.2 years ago
Interventions
Ceftobiprole medocarildrug
Ceftobiprole 500 mg (as 667 mg ceftobiprole medocaril) as a 2 h infusion
Daptomycindrug
Daptomycin 6 mg/kg (up to 10 mg/kg based on institutional standards) as a 0.5 h infusion, with or without aztreonam