NCT03409679TerminatedPhase 3
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
Polyphor Ltd.9 sites in 6 countries41 target enrollmentStarted: March 23, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Enrollment
- 41
- Locations
- 9
- Primary Endpoint
- Clinical cure rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
Murepavadin
Experimental
Murepavadin IV + one anti-pseudomonal antibiotic
Intervention: Murepavadin (Drug)
Two anti-pseudomonal antibiotics
Active Comparator
Association of 2 anti-pseudomonal antibiotics
Intervention: Two anti-pseudomonal antibiotics (Drug)
Outcomes
Primary Outcomes
Clinical cure rate
Time Frame: 21-24 days after start of study treatment
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (9)
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