Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas (PRISM-UDR)

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

This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia in adult subjects

Study Overview

• Status: Terminated
• Conditions: Pneumonia
• Intervention / Treatment: Drug: Murepavadin; Drug: One anti-pseudomonal antibiotic

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 3

Contacts and Locations

Study Locations

• Czechia
  • Břeclav, Czechia
    • Research Site
  • Kolín, Czechia
    • Research Site
• France
  • Argenteuil, France
    • Research Site
• Israel
  • Hadera, Israel
    • Research Site
  • Tel Aviv, Israel
    • Research Site
• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Subject has received mechanical ventilation for at least 48h at the time of the randomisation OR at least 2 of the following signs or symptoms presenting within 24 hours prior to randomization: New onset of cough or worsening of baseline cough and/or dyspnea, tachypnea and/or hypoxemia and/or new onset of sputum or suctioned respiratory secretion characterized by purulent appearance indicative of bacterial infection or a worsening in character of purulent appearance
• Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 25, inclusive, within 24h prior to randomization
• Presence of new or progressive infiltrate on chest X-ray
• Presence of clinical criteria consistent with Pneumonia
• Strong clinical suspicion of pneumonia due to P. aeruginosa

Key Exclusion Criteria:

• Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
• known hypersensitivity to any component of ertapenem, meropenem or to other drugs in the same class or demonstrated anaphylactic reactions to beta-lactams or a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors
• Severe liver or renal impairment
• Expected survival < 72 hours
• Evidence from an available surveillance culture of co infection with ertapenem , meropenem or piperacillin tazobactam resistant Gram negative pathogen(s)
• Women who are pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Murepavadin; Murepavadin + ertapenem	Drug: Murepavadin; Murepavadin + ertapenem
Active Comparator: Anti-pseudomonal antibiotic; One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam)	Drug: One anti-pseudomonal antibiotic; Either meropenem or piperacillin-tazobactam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All cause mortality rates	28 days after start of study treatment

Collaborators and Investigators

• Sponsor: Polyphor Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): July 17, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Anti-Infective Agents; Anti-Bacterial Agents; Murepavadin
• Other Study ID Numbers: POL7080-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No