A Multicenter, Open Label, Sponsor Blinded, Randomized, Active Controlled, Parallel Group, Pivotal Study to Evaluate the Efficacy, Safety, and Tolerability of Murepavadin Given With Ertapenem Versus an Anti-pseudomonal-β-lactam-based Antibiotic in Adult Subjects With Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
Phase of Trial: Phase III
Latest Information Update: 24 Sep 2019
Price : $35 *
At a glance
- Drugs Murepavadin (Primary) ; Ertapenem; Meropenem; Piperacillin/tazobactam
- Indications Nosocomial pneumonia; Pseudomonal infections
- Focus Registrational; Therapeutic Use
- Acronyms PRISM-UDR
- 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.
- 24 May 2019 This trial has been suspended in Hungary according to European Clinical Trials Database