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A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM- AVIBACTAM (ATM- AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO -Β- LACTAMASE (MBL)

Trial Profile

A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM- AVIBACTAM (ATM- AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO -Β- LACTAMASE (MBL)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2019

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At a glance

  • Drugs Avibactam/aztreonam (Primary) ; Aminoglycosides; Colistin; Fosfomycin; Meropenem; Metronidazole; Polymixin B; Tigecycline
  • Indications Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 20 Nov 2019 Planned End Date changed from 25 Oct 2021 to 10 Dec 2021.
    • 20 Nov 2019 Planned primary completion date changed from 7 Oct 2021 to 23 Nov 2021.
    • 20 Nov 2019 Planned initiation date changed from 13 Apr 2020 to 27 Jul 2020.
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