At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 969 enrolled
Drug / intervention
ceftazidim-avibactam (CAZ-AVI, experimental product) +1 moredrug
Likely dose
ceftazidim-avibactam (CAZ-AVI, experimental product) 2000mgfrom 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, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults
In Brief
A Phase 3 clinical trial evaluating ceftazidim-avibactam (CAZ-AVI, experimental product) and meropenem (active comparator) for Nosocomial Pneumonia (NP) and Ventilator-associated Pneumonia (VAP). Completed, enrolled 969 participants across 123 sites in 26 countries.
Detailed Summary
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Brazil, Bulgaria, China, Czechia, France, Hungary, India, Italy, Japan, Latvia, Mexico, Peru, Philippines, Poland, Romania, Russia, Slovenia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartApr 2013
Primary CompletionJan 2016
TodayJul 2026
First PostedMar 11, 2013
Enrollment StartApr 1, 2013
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 13.3 years ago
Interventions
ceftazidim-avibactam (CAZ-AVI, experimental product)drug
2000mg ceftazidime plus 500mg avibactam
meropenem (active comparator)drug
1000mg of Meropenem