Clinical Trials Directory

Trials / Completed

CompletedNCT01726023

Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections

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

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

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.

Detailed description

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

Conditions

Interventions

TypeNameDescription
DRUGCeftazidime-avibactamCeftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
DRUGmetronidazoleMetronidazole 500mg/100ml solution for infusion
DRUGMeropenemMeropenem powder for solution for infusion 1000mg

Timeline

Start date
2013-01-01
Primary completion
2015-03-01
Completion
2015-03-01
First posted
2012-11-14
Last updated
2017-09-06
Results posted
2016-04-14

Locations

30 sites across 3 countries: China, South Korea, Vietnam

Source: ClinicalTrials.gov record NCT01726023. Inclusion in this directory is not an endorsement.