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Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa

NCT03409679 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-08-28

No results posted yet for this study

Summary

This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability, and pharmacokinetics of intravenous murepavadin combined with of one anti-pseudononas antibiotic with that of two anti-pseudomonas antibiotics in the treatment of ventilator-associated bacterial pneumonia (VABP) in adult subjects.

Conditions

Interventions

DRUG

Murepavadin

Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)

DRUG

Two anti-pseudomonal antibiotics

Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin

Sponsors & Collaborators

  • Polyphor Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-23
Primary Completion
2019-07-17
Completion
2019-07-17
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Croatia
  • Estonia
  • France
  • Greece
  • Hungary
  • Israel
  • Mexico
  • South Africa
  • South Korea
  • Spain
  • Thailand

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 NCT03409679 on ClinicalTrials.gov