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: 13 Oct 2019
Price : $35 *
At a glance
- Drugs Murepavadin (Primary) ; Amikacin; Cefepime; Ceftazidime; Ciprofloxacin; Colistimethate sodium; Colistimethate sodium; Colistin; Levofloxacin; Meropenem; Piperacillin/tazobactam
- Indications Nosocomial pneumonia
- Focus Registrational; Therapeutic Use
- Acronyms PRISM-MDR
- Sponsors Polyphor
- 17 Jul 2019 According to a Polyphor media release, the company has decided to close the study of murapavadin intravenous (i.v.) for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), based on the findings of a rise of creatinine concentration in the serum of patients indicating a higher than expected frequency of acute kidney injury have been confirmed by the analysis of all patients in the murepavadin arm of the PRISM MDR study.
- 17 Jul 2019 Status changed from suspended to discontinued, according to a Polyphor media release.
- 13 May 2019 Status changed from recruiting to suspended due to safety data review.