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
Phase of Trial: Phase III
Latest Information Update: 26 Sep 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
- 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.