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Trial · Interventional

TerminatedPhase 3Registry data

Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas

Short name PRISM-UDR

NCTNCT03582007 (opens ClinicalTrials.gov in a new tab)Other idPOL7080-010
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 3
Enrollment
2 participants (actual)
Sponsor
Polyphor Ltd. · Industry
Design
Randomized · Single masking
Countries
4 countries

United States, Czechia, France, Israel

Start
22 Oct 2018
Primary completion
17 Jul 2019
Completion
17 Jul 2019
First posted
10 Jul 2018
Last update posted
28 Aug 2019
Conditions
Pneumonia

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 3

    PRISM-UDR

    NCT03582007

    22 Oct 2018 to 17 Jul 2019

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • MurepavadinDrug
  • One anti-pseudomonal antibioticDrug

Arms2

  • Experimental

    Murepavadin

    Murepavadin + ertapenem

  • Active comparator

    Anti-pseudomonal antibiotic

    One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. All cause mortality rates

    Time frame · 28 days after start of study treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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