drugset / Trial / NCT03409679
Pivotal Study in VAP Suspected or Confirmed to be Due to Pseudomonas Aeruginosa
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-03-23
- Primary completion
- 2019-07-17
- Completion
- 2019-07-17
Outcome
Outcome not reported
Stopped: “Safety data review”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amikacin | Small molecule | — | — |
| Comparator | Cefepime | Small molecule | — | — |
| Comparator | Colistin | Other / unclassified | — | — |
| Comparator | Levofloxacin | Small molecule | — | — |
| Comparator | Meropenem | Small molecule | — | — |
| Subject | Murepavadin | Peptide | — | Intravenous |
| Comparator | Piperacillin-tazobactam | Unknown | — | — |
| Comparator | ceftazidine | Unknown | — | — |
| Comparator | ciprofoxacin | Unknown | — | — |