A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

Trial Profile

A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2018

At a glance

  • Drugs Murepavadin (Primary) ; Amikacin; Cefepime; Ceftazidime; Ciprofloxacin; Colistimethate sodium; Levofloxacin; Meropenem; Piperacillin
  • Indications Nosocomial pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms PRISM-MDR
  • Sponsors Polyphor
  • Most Recent Events

    • 29 Mar 2018 Status changed from not yet recruiting to recruiting.
    • 27 Mar 2018 According to a Polyphor media release,The study was designed based on feedback from the European Medicines Agency (EMA) and is agreed as the basis for a potential approval in the EU.
    • 27 Mar 2018 According to a Polyphor media release, first patient has been enrolled in this study.
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