A study comparing Ceftazidime-Avibactam+Metronidazole versus Meropenem in adults with complicated intra-abdominal infections

Study identifier:D4280C00005

ClinicalTrials.gov identifier:NCT01500239

EudraCT identifier:2011-003895-35

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Complicated Intra-Abdominal Infection

Phase

Phase 3

Healthy volunteers

No

Study drug

CAZ-AVI, Metronidazole, Meropenem

Sex

All

Actual Enrollment

577

Study type

Interventional

Age

18 Years - 90 Years

Date

Study Start Date: 01 Apr 2012
Primary Completion Date: 01 Apr 2014
Study Completion Date: 01 Apr 2014

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Cerexa, Inc.

Inclusion and exclusion criteria