CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 550 enrolled
Drug / intervention
Meropenem-Vaborbactam +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02166476
NCT02166476Phase 3Completed

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

Melinta Therapeutics, Inc.·interventional·Posted Jun 18, 2014·Updated Jun 11, 2018

In Brief

A Phase 3 clinical trial evaluating Meropenem-Vaborbactam, Piperacillin-Tazobactam, and 2 other interventions for Urinary Tract Infection Complicated and Acute Pyelonephritis. Completed, enrolled 550 participants across 77 sites in 17 countries.

Detailed Summary

Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelarus, Brazil, Bulgaria, Czechia, Greece, Hungary, Italy, Peru, Poland, Romania, Slovakia, Slovenia, South Korea, Spain, Taiwan, Ukraine, United States

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 18, 2014
Enrollment StartNov 20, 2014
Primary CompletionApr 28, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.0 years ago

Interventions

Meropenem-Vaborbactamdrug

Meropenem-vaborbactam

Piperacillin-Tazobactamdrug

Piperacillin-tazobactam

Levofloxacindrug

Levofloxacin

Salinedrug

Saline