Trials / Withdrawn
WithdrawnNCT03006679
A Study of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia
A Phase IIIb, Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Efficacy, Safety, and Tolerability of Meropenem-Vaborbactam Versus Piperacillin/Tazobactam in the Treatment of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia in Hospitalized Adults (TANGO III)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Melinta Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Hospital-Acquired Bacterial Pneumonia
- Ventilator-Associated Bacterial Pneumonia
- Hospital-Acquired Pneumonia
- Ventilator-Associated Pneumonia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Meropenem-Vaborbactam | meropenem 2 g and vaborbactam 2 g |
| DRUG | Piperacillin/Tazobactam | piperacillin 4 g and tazobactam 0.5 g |
Timeline
- Start date
- 2018-08-01
- Primary completion
- 2020-06-01
- Completion
- 2020-12-01
- First posted
- 2016-12-30
- Last updated
- 2019-01-11
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03006679. Inclusion in this directory is not an endorsement.