Clinical Trials Directory

Trials / Completed

CompletedNCT01808092

A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
969 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

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

Detailed description

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

Conditions

Interventions

TypeNameDescription
DRUGceftazidim-avibactam (CAZ-AVI, experimental product)2000mg ceftazidime plus 500mg avibactam
DRUGmeropenem (active comparator)1000mg of Meropenem

Timeline

Start date
2013-04-01
Primary completion
2016-01-01
Completion
2016-01-01
First posted
2013-03-11
Last updated
2017-09-06
Results posted
2017-02-03

Locations

123 sites across 26 countries: Argentina, 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

Source: ClinicalTrials.gov record NCT01808092. Inclusion in this directory is not an endorsement.