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A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS

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Trial Profile

A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2025

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At a glance

  • Drugs Avibactam (Primary) ; Avibactam/aztreonam (Primary) ; Aztreonam (Primary) ; Colistimethate sodium; Colistin; Meropenem; Metronidazole
  • Indications Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Ventilator associated pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms REVISIT
  • Sponsors Pfizer

Most Recent Events

  • 07 Feb 2025 According to an AbbVie media release, EMBLAVEO will be available for commercial use in the U.S. in Q3 2025.
  • 07 Feb 2025 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/beta-lactamase inhibitor combination antibiotic for patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI), including those caused by the susceptible Gram-negative microorganisms.
  • 01 Feb 2025 Results(Between April 5, 2018, and Feb 23, 2023) published in The Lancet Infectious Diseases

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