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

NCT03582007 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-08-28

No results posted yet for this study

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

Interventions

DRUG

Murepavadin

Murepavadin + ertapenem

DRUG

One anti-pseudomonal antibiotic

Either meropenem or piperacillin-tazobactam

Sponsors & Collaborators

  • Polyphor Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2019-07-17
Completion
2019-07-17
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • France
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582007 on ClinicalTrials.gov