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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

Trial Profile

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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2019

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At a glance

  • Drugs Murepavadin (Primary) ; Ertapenem; Meropenem; Piperacillin/tazobactam
  • Indications Nosocomial pneumonia; Pseudomonal infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PRISM-UDR
  • Sponsors Polyphor
  • Most Recent Events

    • 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
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