ClinicalTrials.gg
TerminatedNCT03582007PRISM-UDRUpdated Aug 28, 2019

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

A Phase 3 interventional study of Murepavadin and One anti-pseudomonal antibiotic in Pneumonia, sponsored by Polyphor Ltd.. Terminated at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-28.

Sponsored by Polyphor Ltd. · Phase 3, Interventional, and Treatment

Why this study was terminated
Safety data review

From the registry’s dates

  • Primary completion was Jul 2019, 7 years 3 months ago, and no results have been posted to the registry.

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Phase
Phase 3
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 344 studies in Pneumonia with a site in United States — 41 open to participants now, 53 under way, 8 of them phase 3. Pneumonia · United States.

Enrollment
240th of 263
2 · median 91
Started
2018
with 17 others
Phase 3
49 of 344
5 open now
Registered
183rd of 344
by date

Among the 344 studies in Pneumonia with a site in United States, this one is the 240th largest by enrollment of the 263 interventional ones that give a count, is one of 18 that started in 2018, is one of 49 in phase 3, and was the 183rd registered.

Pneumonia

1,566 studies on the registry are indexed under Pneumonia; 266 are open to participants now.

Browse Pneumonia studies →

Open to participants now

41 of the 344 studies in Pneumonia with a site in United States are open now. Recruiting first, the newest first:

36 more — sign in →

All 41 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 158 Pneumonia studies recruiting now, 84 (53%) set no upper age limit and 47 (30%) stop at 75 or younger; 41 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Pneumonia

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Murepavadin

    Murepavadin + ertapenem

    Drug: Murepavadin

  • Active comparator
    Anti-pseudomonal antibiotic

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

    Drug: One anti-pseudomonal antibiotic

Interventions

  • Murepavadin + ertapenem

  • DrugOne anti-pseudomonal antibiotic

    Either meropenem or piperacillin-tazobactam

06

What researchers measure

Primary outcomes

  1. All cause mortality rates

    Time frame: 28 days after start of study treatment

07

Study locations

7 sites
  • Research site
    Iowa City, Iowa 52242, United States
  • Research Site
    Pittsburgh, Pennsylvania 15213, United States
  • Research site
    Břeclav, Czechia
  • Research site
    Kolín, Czechia
  • Research site
    Argenteuil, France
  • Research site
    Hadera, Israel
  • Research site
    Tel Aviv, Israel
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2018 to primary completion in Jul 2019, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2018
First posted
Jul 10, 2018
StartActual
Oct 22, 2018
Primary completionActual
Jul 17, 2019
CompletionActual
Jul 17, 2019
Last update
Aug 28, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03582007
Lead sponsor
Polyphor Ltd.
Responsible party
Sponsor
First posted
Jul 10, 2018
Start date
Oct 22, 2018
Primary completion
Jul 17, 2019
Completion
Jul 17, 2019
Last update
Aug 28, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Murepavadin

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