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

NCT03582007 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: POL7080-010
• Study Type: interventional
• Target: 2
• Locations: 4 countries
• Sites: 7

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

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• All cause mortality rates

  28 days after start of study treatment

Study Arms (2)

Murepavadin

EXPERIMENTAL

Murepavadin + ertapenem

Drug: Murepavadin

Anti-pseudomonal antibiotic

ACTIVE COMPARATOR

One anti-pseudomonal-β-lactam-based antibiotic (either meropenem or piperacillin-tazobactam)

Drug: One anti-pseudomonal antibiotic

Interventions

Murepavadin DRUG

Murepavadin + ertapenem

Murepavadin

One anti-pseudomonal antibiotic DRUG

Either meropenem or piperacillin-tazobactam

Anti-pseudomonal antibiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polyphor Ltd.: lead

Study Sites (7)

Research site

Iowa City, Iowa, 52242, United States

Location

Research Site

Pittsburgh, Pennsylvania, 15213, United States

Location

Research site

Břeclav, Czechia

Location

Research site

Kolín, Czechia

Location

Research site

Argenteuil, France

Location

Research site

Hadera, Israel

Location

Research site

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Pneumonia

Interventions

murepavadin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Sponsor blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 10, 2018
• Study Start: October 22, 2018
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-05

Locations

FR (1); CZ (2); US (2); IL (2)