Trials / Terminated
TerminatedNCT03582007
Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Polyphor Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Murepavadin | Murepavadin + ertapenem |
| DRUG | One anti-pseudomonal antibiotic | Either meropenem or piperacillin-tazobactam |
Timeline
- Start date
- 2018-10-22
- Primary completion
- 2019-07-17
- Completion
- 2019-07-17
- First posted
- 2018-07-10
- Last updated
- 2019-08-28
Locations
7 sites across 4 countries: United States, Czechia, France, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03582007. Inclusion in this directory is not an endorsement.