At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 465 enrolled
Drug / intervention
ZTI-01 +1 moredrug
Likely dose
ZTI-01 6gfrom 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.
Randomized, Double-Blind, Comparative Study to Evaluate the Safety and Efficacy of ZTI-01 vs Piperacillin/Tazobactam in the Treatment of cUTI/AP Infection in Hospitalized Adults
In Brief
A Phase 3 clinical trial evaluating ZTI-01 and Piperacillin-tazobactam for Urinary Tract Infection Symptomatic and 2 related conditions. Completed, enrolled 465 participants across 68 sites in 16 countries.
Detailed Summary
The purpose of the study is to demonstrate the safety and efficacy of ZTI-01 (IV fosfomycin) as non-inferior to piperacillin/tazobactam in overall success (clinical cure and microbiologic eradication) for the treatment of hospitalized patients with complicated urinary tract infections (cUTI) or acute pyelonephritis (AP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infection Symptomatic, Acute Pyelonephritis, Urinary Tract Infection Complicated
CountriesBelarus, Bulgaria, Croatia, Czechia, Estonia, Georgia, Greece, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Slovakia, Ukraine, United States
CollaboratorsMedpace, Inc.
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2016
First PostedApr 2016
Primary CompletionJan 2017
Study CompletionMay 2017
TodayJul 2026
First PostedApr 28, 2016
Enrollment StartApr 1, 2016
Primary CompletionJan 12, 2017
Study CompletionMay 30, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.2 years ago
Interventions
ZTI-01drug
6g ZTI-01 intravenous infusion TID q8 hours
Piperacillin-tazobactamdrug
4.5g piperacillin-tazobactam intravenous infusion TID q8 hours