drugset / Trial / NCT03006679
A Study of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the efficacy, safety, tolerability, and pharmacokinetics (PK) of meropenem-vaborbactam compared to piperacillin/tazobactam for 7 to 14 days in the treatment of hospitalized adults who meet clinical, radiographic, and microbiological criteria for hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).
Timeline
- Start
- 2018-08
- Primary completion
- 2020-06
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meropenem | Small molecule | 2 g | Intravenous |
| Comparator | Piperacillin | Small molecule | 4 g | Intravenous |
| Comparator | Tazobactam | Small molecule | 0.5 g | Intravenous |
| Subject | Vaborbactam | Small molecule | 2 g | Intravenous |