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: 10 Feb 2019
At a glance
- Drugs Ertapenem (Primary) ; Murepavadin (Primary) ; Meropenem; Piperacillin/tazobactam
- Indications Nosocomial pneumonia; Pseudomonal infections
- Focus Registrational; Therapeutic Use
- Acronyms PRISM-UDR
- Sponsors Polyphor
- 24 Oct 2018 According to a Polyphor media release, the company has reached agreement with the U.S. Food and Drug Administration (FDA) on protocol of the trial. With the agreed protocol, the FDA requested not to proceed with an interim analysis for the intention of stopping the trial early due to the small sample size. Therefore, the basis for a potential registration in the United States will be the completion of the single pivotal Phase III study, PRISM-UDR.
- 24 Oct 2018 According to a Polyphor media release, the company expects to recruit the first patient by Q1 19. The miTT population will comprise 210 evaluable subjects (105 subjects per arm) with nosocomial pneumonia confirmed to be due to Pseudomonas aeruginosa.
- 24 Oct 2018 Status changed from not yet recruiting to recruiting, according to a Polyphor media release.