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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2023

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At a glance

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

Most Recent Events

  • 13 Sep 2023 Results of a pooled post-hoc analysis from following clinical studies: NCT01499290, NCT01726023, NCT01644643, NCT01595438, NCT01599806 and NCT01808092 assessing clinical and microbiological outcomes and safety in patients with infections caused by beta-lactamase-producing Gram-negative pathogens published in the Journal of Antimicrobial Chemotherapy
  • 25 Oct 2020 Results assessing anti-microbial activity ceftazidime-avibactam and comparator agents against enterobacterales and pseudomonas aeruginosa with overexpression of AmpC beta-lactamase from phase 3 studies (RECLAIM , REPRISE, RECAPTURE & REPROVE), presented at the IDWeek 2020.
  • 21 Apr 2020 Results of an exploratory analysis assessing efficacy and safety of ceftazidime-avibactam in adults with Gram-negative bacteraemia from five phase III randomised clinical trials presented at the 30th European Congress of Clinical Microbiology and Infectious Diseases

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