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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Jul 2018

At a glance

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

    • 09 Apr 2018 Status changed from not yet recruiting to recruiting.
    • 11 Jan 2018 Planned End Date changed from 1 May 2020 to 1 Jun 2020.
    • 11 Jan 2018 Planned primary completion date changed from 1 May 2020 to 1 Jun 2020.
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