A Phase III, Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections (cIAIs) in Hospitalized Adults
Phase of Trial: Phase III
Latest Information Update: 05 Mar 2018
At a glance
- Drugs Avibactam/ceftazidime (Primary) ; Meropenem; Metronidazole
- Indications Intra-abdominal infections
- Focus Registrational; Therapeutic Use
- Acronyms RECLAIM-1
- Sponsors AstraZeneca
- 27 Mar 2017 Results of this and one other phase III trial published in the Antimicrobial Agents and Chemotherapy.
- 28 Jun 2016 According to AstraZeneca media release, the European Commission has granted marketing authorisation for Zavicefta (ceftazidime-avibactam, previously known as CAZ AVI), a new combination antibiotic for the treatment of patients with serious Gram-negative bacterial infections requiring hospitalisation.
- 29 Apr 2016 According to an AstraZeneca media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion, recommending the approval of a new antibiotic, avibactam/ceftazidime (CAZ AVI) 2g/0.5g powder. The CHMP also recommended that CAZ AVI be indicated for the treatment of infections caused by aerobic Gram-negative organisms in adult patients who have limited treatment options.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History