Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas (PRISM-UDR)
Primary Purpose
Pneumonia
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Murepavadin
One anti-pseudomonal antibiotic
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia
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 hypersensitivity 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
Sites / Locations
- Research site
- Research Site
- Research site
- Research site
- Research site
- Research site
- Research site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Murepavadin
Anti-pseudomonal antibiotic
Arm Description
Murepavadin + ertapenem
One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam)
Outcomes
Primary Outcome Measures
All cause mortality rates
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03582007
Brief Title
Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas
Acronym
PRISM-UDR
Official Title
A Multicenter, Open Label, Sponsor Blinded, Randomized, Active Controlled, Parallel Group, Pivotal Study to Evaluate the Efficacy, Safety, and Tolerability of Murepavadin Given With Ertapenem Versus an Anti-pseudomonal-β-lactam-based Antibiotic in Adult Subjects With Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Safety data review
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Polyphor Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Sponsor blinded
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Murepavadin
Arm Type
Experimental
Arm Description
Murepavadin + ertapenem
Arm Title
Anti-pseudomonal antibiotic
Arm Type
Active Comparator
Arm Description
One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam)
Intervention Type
Drug
Intervention Name(s)
Murepavadin
Intervention Description
Murepavadin + ertapenem
Intervention Type
Drug
Intervention Name(s)
One anti-pseudomonal antibiotic
Intervention Description
Either meropenem or piperacillin-tazobactam
Primary Outcome Measure Information:
Title
All cause mortality rates
Time Frame
28 days after start of study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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 hypersensitivity 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
Facility Information:
Facility Name
Research site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Research site
City
Břeclav
Country
Czechia
Facility Name
Research site
City
Kolín
Country
Czechia
Facility Name
Research site
City
Argenteuil
Country
France
Facility Name
Research site
City
Hadera
Country
Israel
Facility Name
Research site
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
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Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas
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