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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

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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2020

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At a glance

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

    • 15 Sep 2020 Status changed from suspended to recruiting.
    • 14 Aug 2020 Planned End Date changed from 30 Nov 2021 to 30 Aug 2022.
    • 14 Aug 2020 Planned primary completion date changed from 14 Nov 2021 to 14 Aug 2022.
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