Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
Phase 3
Terminated
- Conditions
- Pneumonia
- Interventions
- Drug: Two anti-pseudomonal antibiotics
- Registration Number
- NCT03409679
- Lead Sponsor
- Polyphor Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Two anti-pseudomonal antibiotics Two anti-pseudomonal antibiotics Association of 2 anti-pseudomonal antibiotics Murepavadin Murepavadin Murepavadin IV + one anti-pseudomonal antibiotic
- Primary Outcome Measures
Name Time Method Clinical cure rate 21-24 days after start of study treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Research site
🇪🇸Girona, Spain
Research Site
🇹🇭Nonthaburi, Thailand
Research site 1
🇿🇦Tshwane, Gauteng, South Africa
Research site 2
🇰🇷Seoul, Korea, Republic of
Research site 3
🇫🇷Paris, France
Reasearch site
🇭🇺Ózd, BZ, Hungary
Research Site 3
🇰🇷Seoul, Korea, Republic of
Research Site 2
🇹🇭Bangkok, Thailand
Research Site 1
🇹🇭Bangkok, Thailand