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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: 17 Jun 2019

At a glance

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

    • 14 Jun 2018 Results (n=2585) of pooled data (RECLAIM 1, RECLAIM 2, REPROVE, REPRISE, RECAPTURE 1 and RECAPTURE 2) published in the Journal of Antimicrobial Chemotherapy
    • 11 Jun 2018 The protocol of this trial amended in ear 3 (of 4) of the study increased the total daily CAZ-AVI dose for patients with MSRIB by 50%, consistent with the FDA-approved CAZ-AVI dosing recommendations, as reported in an abstract presented at the ASM Microbe 2018.
    • 11 Jun 2018 Results of a subgroup analysis presented at the ASM Microbe 2018
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