Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas (PRISM-UDR)

Polyphor

Status and phase

Terminated

Phase 3

Conditions

Pneumonia

Treatments

Drug: Murepavadin

Drug: One anti-pseudomonal antibiotic

Study type

Interventional

Funder types

Industry

Identifiers

NCT03582007

POL7080-010

Details and patient eligibility

About

This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia in adult subjects

Enrollment

2 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 OR at least 2 of the following signs or symptoms presenting within 24 hours prior to randomization: New onset of cough or worsening of baseline cough and/or dyspnea, tachypnea and/or hypoxemia and/or new onset of sputum or suctioned respiratory secretion characterized by purulent appearance indicative of bacterial infection or a worsening in character of purulent appearance
Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 25, inclusive, within 24h prior to randomization
Presence of new or progressive infiltrate on chest X-ray
Presence of clinical criteria consistent with Pneumonia
Strong clinical suspicion of pneumonia due to P. aeruginosa

Key Exclusion Criteria:

Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
known hypersensitivity to any component of ertapenem, meropenem or to other drugs in the same class or demonstrated anaphylactic reactions to beta-lactams or a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors
Severe liver or renal impairment
Expected survival < 72 hours
Evidence from an available surveillance culture of co infection with ertapenem , meropenem or piperacillin tazobactam resistant Gram negative pathogen(s)
Women who are pregnant or nursing