At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 493 enrolled
Drug / intervention
CAZ-AVI +2 moredrug
Likely dose
CAZ-AVI 2000 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 Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults
In Brief
A Phase 3 clinical trial evaluating CAZ-AVI, Metronidazole, and 1 other intervention for Complicated Intra-Abdominal Infection. Completed, enrolled 493 participants across 56 sites in 20 countries.
Detailed Summary
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplicated Intra-Abdominal Infection
CountriesArgentina, Bulgaria, Croatia, Czechia, Hungary, India, Israel, Latvia, Malaysia, Mexico, Netherlands, Peru, Romania, Russia, South Africa, Spain, Taiwan, Thailand, Ukraine, United States
CollaboratorsForest Laboratories
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartMar 2012
Primary CompletionApr 2014
TodayJul 2026
First PostedDec 26, 2011
Enrollment StartMar 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.5 years ago
Interventions
CAZ-AVIdrug
Ceftazidime 2000 mg and 500 mg of avibactam
Metronidazoledrug
500 mg of Metronidazole
Meropenemdrug
1 gram of Meropenem