Trials / Completed
CompletedNCT02166476
Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP
Phase III, Randomized, Double-Blind, Study Evaluating Efficacy/Safety/Tolerability of Meropenem-Vaborbactam Compared to Piperacillin/Tazobactam in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 550 (actual)
- Sponsor
- Melinta Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).
Detailed description
In the current era of increased resistance to extended spectrum cephalosporins, carbapenem antimicrobial agents are frequently the antibiotics of "last defense" for the most resistant pathogens in serious infections, including those found in cUTIs. The recent dissemination of serine carbapenemases in Enterobacteriaceae in many hospitals worldwide now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents. Rempex is developing meropenem-vaborbactam administered as a fixed combination by intravenous infusion to treat serious Gram-negative infections such as cUTIs, including those infections caused by bacteria resistant to currently available carbapenems.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Meropenem-Vaborbactam | Meropenem-vaborbactam |
| DRUG | Piperacillin-Tazobactam | Piperacillin-tazobactam |
| DRUG | Levofloxacin | Levofloxacin |
| DRUG | Saline | Saline |
Timeline
- Start date
- 2014-11-20
- Primary completion
- 2016-04-28
- Completion
- 2016-04-28
- First posted
- 2014-06-18
- Last updated
- 2018-06-11
- Results posted
- 2017-10-26
Locations
77 sites across 17 countries: United States, Belarus, Brazil, Bulgaria, Czechia, Greece, Hungary, Italy, Peru, Poland, Romania, Slovakia, Slovenia, South Korea, Spain, Taiwan, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02166476. Inclusion in this directory is not an endorsement.