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

Pneumonia Clinical Trial

— PRISM-UDR  

Official title:

A Multicenter, Open Label, Sponsor Blinded, Randomized, Active Controlled, Parallel Group, Pivotal Study to Evaluate the Efficacy, Safety, and Tolerability of Murepavadin Given With Ertapenem Versus an Anti-pseudomonal-β-lactam-based Antibiotic in Adult Subjects With Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03582007
• Other study ID #: POL7080-010
• Status: Terminated
• Phase: Phase 3
• Start date: October 22, 2018
• Est. completion date: July 17, 2019

Study information

• Verified date: May 2019
• Source: Polyphor Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 17, 2019
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Healthcare-Associated Pneumonia
• Pneumonia

Intervention

Drug:
• Murepavadin
Murepavadin + ertapenem
• One anti-pseudomonal antibiotic
Either meropenem or piperacillin-tazobactam

Locations

Country	Name	City	State
Czechia	Research site	Breclav
Czechia	Research site	Kolín
France	Research site	Argenteuil
Israel	Research site	Hadera
Israel	Research site	Tel Aviv
United States	Research site	Iowa City	Iowa
United States	Research Site	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Polyphor Ltd.

Countries where clinical trial is conducted

United States,  Czechia,  France,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality rates		28 days after start of study treatment