Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas

Phase 3

Terminated

• Conditions: Pneumonia
• Interventions: Drug: One anti-pseudomonal antibiotic; Drug: Murepavadin

• Registration Number: NCT03582007
• Lead Sponsor: Polyphor Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-27
• Study First Submitted QC: 2018-06-27
• Study First Posted: 2018-07-10
• Study Start: 2018-10-22
• 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: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-pseudomonal antibiotic	One anti-pseudomonal antibiotic	One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam)
Murepavadin	Murepavadin	Murepavadin + ertapenem

Primary Outcome Measures

Name	Time	Method
All cause mortality rates	28 days after start of study treatment

Trial Locations

Locations (2)

Research Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

Research site; 🇮🇱 Tel Aviv, Israel