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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: 23 Jan 2025

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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

  • 22 Apr 2024 According to a Pfizer media release, company announced that the European Commission has granted marketing authorization for EMBLAVEO (aztreonam-avibactam) for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.
  • 22 Apr 2024 According to a Pfizer media release, the marketing authorization of EMBLAVEO is valid in all 27 European Union (EU) member states, as well as in Iceland, Liechtenstein, and Norway. Marketing authorization applications for EMBLAVEO are planned for submission in other countries.
  • 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.

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