Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for hospitalized adults with complicated Intra-Abd Infections - RECLAIM3
Study identifier:D4280C00018
ClinicalTrials.gov identifier:NCT01726023
EudraCT identifier:2011-003893-97
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
Ceftazidime-avibactam, metronidazole, Meropenem
Sex
All
Actual Enrollment
486
Study type
Interventional
Age
18 Years - 90 Years
Date
Study Start Date: 14 Jan 2013
Primary Completion Date: 14 Mar 2015
Study Completion Date: 14 Mar 2015
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2017 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ceftazidime-Avibactam plus metronidazole | Drug: Ceftazidime-avibactam Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Drug: metronidazole Metronidazole 500mg/100ml solution for infusion |
| Active Comparator: Meropenem | Drug: Meropenem Meropenem powder for solution for infusion 1000mg |
Contacts
Investigators
Principal Investigator
Paul A Newell
AstraZeneca LP
