A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

Trial Profile

A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2017

At a glance

  • Drugs Avibactam/ceftazidime (Primary) ; Meropenem
  • Indications Bacterial infections; Nosocomial pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms REPROVE; REPROVE-CAZ-AVI
  • Sponsors AstraZeneca; AstraZeneca AB
  • Most Recent Events

    • 04 Oct 2017 According to an Allergan media release, data from the study will be presented At IDWeek 2017.
    • 02 Oct 2017 According to an Allergan media release, the U.S. Food and Drug Administration has accepted a supplemental New Drug Application for AVYCAZ for priority review. The sNDA filing seeks to expand the current indications for AVYCAZ to include hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia in adult patients based on positive results from this trial. The FDA granted priority review status to the application and is expected to take action on the filing in the 1Q 2018.
    • 25 Apr 2017 Results (n=2000) of subgroup analysis of this and other dataset assessing pharmacokinetic/pharmacodynamic validation presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases.
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