Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

Phase 3

Terminated

• Conditions: Pneumonia
• Interventions: Drug: Two anti-pseudomonal antibiotics; Drug: Murepavadin

• 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

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-24
• Study Start: 2018-03-23
• Status Verified: 2019-05
• Primary Completion: 2019-07-17
• Study Completion: 2019-07-17
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

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

Trial Locations

Locations (9)

Research site; 🇪🇸 Girona, Spain

Research Site 1; 🇹🇭 Bangkok, Thailand

Research Site 2; 🇹🇭 Bangkok, Thailand

Research Site; 🇹🇭 Nonthaburi, Thailand

Research site 1; 🇿🇦 Tshwane, Gauteng, South Africa

Research site 2; 🇰🇷 Seoul, Korea, Republic of

Reasearch site; 🇭🇺 Ózd, BZ, Hungary

Research site 3; 🇫🇷 Paris, France

Research Site 3; 🇰🇷 Seoul, Korea, Republic of