Study Stopped
Safety data review
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
PRISM-MDR
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
1 other identifier
interventional
41
12 countries
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2018
Shorter than P25 for phase_3
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedStudy Start
First participant enrolled
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2019
CompletedAugust 28, 2019
May 1, 2019
1.3 years
January 8, 2018
August 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical cure rate
21-24 days after start of study treatment
Study Arms (2)
Murepavadin
EXPERIMENTALMurepavadin IV + one anti-pseudomonal antibiotic
Two anti-pseudomonal antibiotics
ACTIVE COMPARATORAssociation of 2 anti-pseudomonal antibiotics
Interventions
Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)
Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Polyphor Ltd.lead
Study Sites (61)
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
Ioannina, Greece
Research Site 1
Larissa, Greece
Research Site 2
Larissa, Greece
Research Site
Pátrai, Greece
Research Site
Thessaloniki, Greece
Reasearch site
Budapest, BU, Hungary
Research site
Budapest, BU, Hungary
Reasearch site
Ózd, BZ, Hungary
Research Site
Kistarcsa, Hungary
Research Site
Székesfehérvár, Hungary
Research Site
Vác, Hungary
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Jerusalem, JM, Israel
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Nahariya, Z, Israel
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Tiberias, Z, Israel
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Petah Tikva, Israel
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Safed, Israel
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Tel Litwinsky, Israel
Research Site 1
Guadalajara, Mexico
Research Site 2
Guadalajara, Mexico
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Monterrey, Mexico
Research site 1
Pretoria, Gauteng, South Africa
Research Site
Cape Town, South Africa
Research Site 2
Pretoria, South Africa
Research Site
Pretoria, South Africa
Research Site
Ansansi Danweongu, South Korea
Research Site
Gangwon-do, South Korea
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Gyeongsang, South Korea
Research site
Incheon, South Korea
Research site 1
Seoul, South Korea
Research site 2
Seoul, South Korea
Research Site 3
Seoul, South Korea
Research site
Seoul, South Korea
Research site
Barcelona, B, Spain
Research site
Terrassa, B, Spain
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Girona, Spain
Research Site 1
Bangkok, Thailand
Research Site 2
Bangkok, Thailand
Research Site
Khon Kaen, Thailand
Research Site
Nonthaburi, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2018
First Posted
January 24, 2018
Study Start
March 23, 2018
Primary Completion
July 17, 2019
Study Completion
July 17, 2019
Last Updated
August 28, 2019
Record last verified: 2019-05