Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa (PRISM-MDR)

Polyphor

Status and phase

Terminated

Phase 3

Conditions

Pneumonia

Treatments

Drug: Murepavadin

Drug: Two anti-pseudomonal antibiotics

Study type

Interventional

Funder types

Industry

Identifiers

NCT03409679

POL7080-011

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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