ClinicalTrials.gg
TerminatedNCT03409679PRISM-MDRUpdated Aug 28, 2019

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

A Phase 3 interventional study of Murepavadin and Two anti-pseudomonal antibiotics in Pneumonia, sponsored by Polyphor Ltd.. Terminated at 61 sites in 13 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
41
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 138 studies in Pneumonia with a site in France — 18 open to participants now, 20 under way, 3 of them phase 3. Pneumonia · France.

Enrollment
65th of 79
41 · median 161
Started
2018
with 8 others
Phase 3
25 of 138
3 open now
Registered
51st of 138
by date

Among the 138 studies in Pneumonia with a site in France, this one is the 65th largest by enrollment of the 79 interventional ones that give a count, is one of 9 that started in 2018, is one of 25 in phase 3, and was the 51st 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

18 of the 138 studies in Pneumonia with a site in France are open now. Recruiting first, the newest first:

13 more — sign in →

All 18 open studies →

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

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, 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.

03

Conditions studied

  • Pneumonia

Browse trials for

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
  • 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 or to beta-lactam antibiotics, aminoglycosides, quinolones, colistin, or subjects with a 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
Terms in these criteria, in plain language(4)

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Murepavadin

    Murepavadin IV + one anti-pseudomonal antibiotic

    Drug: Murepavadin

  • Active comparator
    Two anti-pseudomonal antibiotics

    Association of 2 anti-pseudomonal antibiotics

    Drug: Two anti-pseudomonal antibiotics

Interventions

  • Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)

  • DrugTwo anti-pseudomonal antibiotics

    Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin

06

What researchers measure

Primary outcomes

  1. Clinical cure rate

    Time frame: 21-24 days after start of study treatment

07

Study locations

61 sites
  • Research site
    Chicago, Illinois 60208, United States
  • Research site
    Springfield, Missouri 65802, United States
  • Research site
    Greensboro, North Carolina 27403, United States
  • Research Site 1
    Belo Horizonte, Brazil
  • Research Site 2
    Belo Horizonte, Brazil
  • Research Site
    Itaquaquecetuba, Brazil
  • Research Site
    Porto Alegre, Brazil
  • Research Site
    São José Do Rio Preto, Brazil
  • Research site 1
    Zagreb, Croatia
  • Research site 2
    Zagreb, Croatia
  • Research site
    Tallinn, Estonia
  • Reasearch site
    Tartu, Estonia
  • Reasearch site
    Võru, Estonia
  • Research site
    Lille, France
  • Reasearch site
    Limoges, France
  • Research site
    Lyon, France
  • Reasearch site
    Nice, France
  • Research site 1
    Paris, France
  • Research site 2
    Paris, France
  • Research site 3
    Paris, France
  • Research site
    Pierre-Bénite, France
  • Research Site
    Athens, Greece
  • Research Site
    Ioánnina, Greece
  • Research Site 1
    Larissa, Greece
  • Research Site 2
    Larissa, Greece
  • Research Site
    Patra, Greece
  • Research Site
    Thessaloníki, Greece
  • Reasearch site
    Budapest, BU, Hungary
  • Research site
    Budapest, BU, Hungary
  • Reasearch site
    Ózd, BZ, Hungary
  • Research Site
    Kistarcsa, Hungary
  • Research Site
    Szekesfehervar, Hungary
  • Research Site
    Vác, Hungary
  • Research site
    Jerusalem, JM, Israel
  • Research site
    Nahariya, Z, Israel
  • Research site
    Tiberias, Z, Israel
  • Research site
    Petah Tiqva, Israel
  • Research site
    Tel HaShomer, Israel
  • Research site
    Zefat, Israel
  • Research Site
    Ansansi Danweongu, Korea, Republic of
  • Research Site
    Gangwon-do, Korea, Republic of
  • Research site
    Gyeongsang, Korea, Republic of
  • Research site
    Incheon, Korea, Republic of
  • Research site 1
    Seoul, Korea, Republic of
  • Research site 2
    Seoul, Korea, Republic of
  • Research Site 3
    Seoul, Korea, Republic of
  • Research site
    Seoul, Korea, Republic of
  • Research Site 1
    Guadalajara, Mexico
  • Research Site 2
    Guadalajara, Mexico
  • Research Site
    Monterrey, Mexico
  • Research site 1
    Tshwane, Gauteng, South Africa
  • Research Site
    Cape Town, South Africa
  • Research Site
    Pretoria, South Africa
  • Research Site 2
    Tshwane, South Africa
  • Research site
    Barcelona, B, Spain
  • Research site
    Terrassa, B, Spain
  • Research site
    Girona, Spain
  • Research Site 1
    Bangkok, Thailand
  • Research Site 2
    Bangkok, Thailand
  • Research Site
    Khon Kaen, Thailand
  • Research Site
    Nonthaburi, Thailand
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2018 to primary completion in Jul 2019, 15 months.

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

Registered
Jan 8, 2018
First posted
Jan 24, 2018
StartActual
Mar 23, 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
NCT03409679
Lead sponsor
Polyphor Ltd.
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Mar 23, 2018
Primary completion
Jul 17, 2019
Completion
Jul 17, 2019
Last update
Aug 28, 2019

Oversight

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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