NCT06059846

A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,690 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study included a pre-planned interim analysis with stopping criteria for efficacy and futility that was performed by an independent data monitoring committee (IDMC). For full details please refer to the protocol and statistical analysis plan.

Conditions

• Urinary Tract Infection
• Acute Pyelonephritis

Interventions

Type	Name	Description
DRUG	TBP-PI-HBr	TBP-PI-HBr film-coated immediate-release tablets.
DRUG	Imipenem-cilastatin	Sterile powder for reconstitution administered as IV.
DRUG	Dummy Infusion	0.9% sodium chloride administered as IV infusion.
DRUG	Dummy Tablets	TBP-PI-HBr matching dummy tablets.

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-01-27
• Completion: 2025-02-06
• First posted: 2023-09-29
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

85 sites across 19 countries: United States, Argentina, Bosnia and Herzegovina, Brazil, Bulgaria, Croatia, Estonia, Georgia, Greece, Hungary, India, Latvia, Moldova, Poland, Romania, Serbia, Slovakia, South Africa, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study