Trials / Terminated
TerminatedNCT03409679
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
A Multicenter, Open-label, Randomized, Active-controlled, Parallel Group, Pivotal Study to Investigate the Efficacy, Safety and Tolerability, and Pharmacokinetics of Murepavadin Combined With One Anti-pseudomonal Antibiotic Versus Two Anti-pseudomonal Antibiotics in Adult Subjects With Ventilator-associated Bacterial Pneumonia Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Polyphor Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-03-23
- Primary completion
- 2019-07-17
- Completion
- 2019-07-17
- First posted
- 2018-01-24
- Last updated
- 2019-08-28
Locations
61 sites across 13 countries: United States, Brazil, Croatia, Estonia, France, Greece, Hungary, Israel, Mexico, South Africa, South Korea, Spain, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03409679. Inclusion in this directory is not an endorsement.