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Trial · Interventional

TerminatedPhase 3Registry data

Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

Short name PRISM-MDR

NCTNCT03409679 (opens ClinicalTrials.gov in a new tab)Other idPOL7080-011
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 3
Enrollment
41 participants (actual)
Sponsor
Polyphor Ltd. · Industry
Design
Randomized · Open label (no masking)
Countries
13 countries

United States, Brazil, Croatia, Estonia, France, Greece, Hungary, Israel, Mexico, South Africa, South Korea, Spain, Thailand

Start
23 Mar 2018
Primary completion
17 Jul 2019
Completion
17 Jul 2019
First posted
24 Jan 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-MDR

    NCT03409679

    23 Mar 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, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.

Interventions

  • MurepavadinDrug
  • Two anti-pseudomonal antibioticsDrug

Arms2

  • Experimental

    Murepavadin

    Murepavadin IV + one anti-pseudomonal antibiotic

  • Active comparator

    Two anti-pseudomonal antibiotics

    Association of 2 anti-pseudomonal antibiotics

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Clinical cure rate

    Time frame · 21-24 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 * Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 30, inclusive, within 24h prior to randomization * Presence of new or progressive infiltrate on chest X-ray * Presence of clinical criteria consistent with VABP * High probability of VABP caused by Pseudomonas aeriginosa Key Exclusion Criteria: * Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia * Known hypersensitivity or contra-indications to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a clinically significant history of anaphylactic reaction * Severe liver or renal impairment * Women who are pregnant or nursing, or who are of chilbearing potential and unwilling to use acceptable method of birth control

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