At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 494 enrolled
Drug / intervention
CXA-201 and metronidazole +1 moredrug
Likely dose
CXA-201 and metronidazole 1500mgfrom 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 Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Efficacy and Safety of Intravenous CXA-201 With That of Meropenem in Complicated Intraabdominal Infections
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Oct 4, 2011·Updated Nov 16, 2018
In Brief
A Phase 3 clinical trial evaluating CXA-201 and metronidazole and Meropenem for Complicated Intra-abdominal Infection. Completed, enrolled 494 participants across 61 sites in 15 countries.
Detailed Summary
This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA-201 Intravenous (IV) infusions (1500mg q8h) and metronidazole (500mg q8h) versus meropenem (1000mg q8h)for the treatment of adults with Complicated Intraabdominal Infections (cIAI).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Intra-abdominal Infection
CountriesArgentina, Bulgaria, Chile, Croatia, Estonia, Germany, Hungary, Israel, Latvia, Lithuania, Moldova, Poland, Serbia, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 2011
Enrollment StartDec 2011
Primary CompletionOct 2013
Study CompletionOct 2013
TodayJul 2026
First PostedOct 4, 2011
Enrollment StartDec 23, 2011
Primary CompletionOct 3, 2013
Study CompletionOct 15, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.7 years ago
Interventions
CXA-201 and metronidazoledrug
CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
Meropenemdrug
Meropenem IV infusion (1000mg q8h) for 4-14 days