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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Sep 2017

At a glance

  • Drugs Avibactam/ceftazidime (Primary) ; Meropenem; Metronidazole
  • Indications Intra-abdominal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms RECLAIM-1
  • Sponsors AstraZeneca
  • Most Recent Events

    • 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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