Study identifier:D4280C00001
ClinicalTrials.gov identifier:NCT01499290
EudraCT identifier:2011-003893-97
CTIS identifier:N/A
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
Complicated Intra-Abdominal Infection
Phase 3
No
CAZ-AVI, Metronidazole, Meropenem
All
493
Interventional
18 Years - 90 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2016 by AstraZeneca
AstraZeneca
Cerexa, Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: CAZ-AVI + Metronidazole IV treatment | Drug: CAZ-AVI Ceftazidime 2000 mg and 500 mg of avibactam Drug: Metronidazole 500 mg of Metronidazole |
Active Comparator: Meropenem IV treatment | Drug: Meropenem 1 gram of Meropenem |