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

• Status: Terminated
• Trial end date: 2019-07-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Polyphor Ltd.
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Murepavadin

Criteria

Key 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