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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)

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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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2024

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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
  • Acronyms ASSEMBLE
  • Sponsors Pfizer

    • Most Recent Events

    • 01 Jun 2023 According to a Pfizer media release, this trial is funded in whole or part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under OTA number HHSO100201500029C, the Innovative Medicines Initiative Joint Undertaking under grant agreement 115620, resources of which are composed of financial contribution from the European Union Seventh Framework Programme.
    • 01 Jun 2023 According to a Pfizer Media Release, data from the REVISIT and ASSEMBLE studies are expected to form the basis for planned regulatory filings in the European Union, United Kingdom, China, and the U.S. in the second half of 2023.
    • 01 Jun 2023 According to a Pfizer media release, results from this trial will be submitted for scientific publication.
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