Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa (PRISM-MDR)

August 23, 2019 updated by: Polyphor Ltd.

A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Murepavadin
Murepavadin IV + one anti-pseudomonal antibiotic
Drug: Murepavadin
Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)
Active Comparator: Two anti-pseudomonal antibiotics
Association of 2 anti-pseudomonal antibiotics
Drug: Two anti-pseudomonal antibiotics
Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical cure rate
Time Frame: 21-24 days after start of study treatment
21-24 days after start of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polyphor Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2018

Primary Completion (Actual)

July 17, 2019

Study Completion (Actual)

July 17, 2019

Study Registration Dates

First Submitted

January 8, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 24, 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

Other Study ID Numbers

  • POL7080-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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