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
Latest Information Update: 08 May 2024
At a glance
- Drugs Avibactam (Primary) ; Avibactam/aztreonam (Primary) ; Aztreonam (Primary) ; Colistimethate sodium; Colistin; Meropenem; Metronidazole
- Indications Gram-negative infections; Intra-abdominal infections; Nosocomial pneumonia; Ventilator associated pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms REVISIT
- Sponsors Pfizer
- 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.
- 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.
- 05 Oct 2023 According to a Pfizer media release, data from this study will be presented at the upcoming IDWeek 2023 held in Boston from October 11-15, 2023.