CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,690 enrolled
Drug / intervention
TBP-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.

Search/NCT06059846
NCT06059846Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Spero Therapeutics·interventional·Posted Sep 29, 2023·Updated Mar 10, 2026

In Brief

A Phase 3 clinical trial evaluating TBP-PI-HBr, Imipenem-cilastatin, and 2 other interventions for Urinary Tract Infection and Acute Pyelonephritis. Completed, enrolled 1,690 participants across 85 sites in 19 countries.

Detailed Summary

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (greater than or equal to (≥)18 years of age) with cUTI or AP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infection, Acute Pyelonephritis
CountriesArgentina, Bosnia and Herzegovina, Brazil, Bulgaria, Croatia, Estonia, Georgia, Greece, Hungary, India, Latvia, Moldova, Poland, Romania, Serbia, Slovakia, South Africa, Turkey (Türkiye), United States
CollaboratorsGlaxoSmithKline

Timeline

Phase 3CompletedFinished
202420252026
First PostedSep 29, 2023
Enrollment StartDec 21, 2023
Primary CompletionJan 27, 2025
Study CompletionFeb 6, 2025
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 2.8 years ago

Interventions

TBP-PI-HBrdrug

TBP-PI-HBr film-coated immediate-release tablets.

Imipenem-cilastatindrug

Sterile powder for reconstitution administered as IV.

Dummy Infusiondrug

0.9% sodium chloride administered as IV infusion.

Dummy Tabletsdrug

TBP-PI-HBr matching dummy tablets.