At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,372 enrolled
Drug / intervention
TBPM-PI-HBr +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.
A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
In Brief
A Phase 3 clinical trial evaluating TBPM-PI-HBr, Ertapenem, and 2 other interventions for Complicated Urinary Tract Infection and Acute Pyelonephritis. Completed, enrolled 1,372 participants across 96 sites in 15 countries.
Detailed Summary
The key purpose of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of tebipenem pivoxil hydrobromide (TBPM-PI-HBr) compared to intravenous (IV) ertapenem, in participants with complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBulgaria, Czechia, Estonia, Georgia, Hungary, Latvia, Moldova, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartJun 2019
Primary CompletionMay 2020
Study CompletionMay 2020
TodayJul 2026
First PostedDec 28, 2018
Enrollment StartJun 3, 2019
Primary CompletionMay 20, 2020
Study CompletionMay 27, 2020
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 7.5 years ago
Interventions
TBPM-PI-HBrdrug
TBPM-PI-HBr tablets administered orally.
Ertapenemdrug
Antibiotic Therapy for cUTI.
Dummy Infusiondrug
Dummy intravenous infusion.
Dummy tabletsdrug
Dummy tablets orally.