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)

• Status: Recruiting
• Trial end date: 2025-12-01

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 (≥18 years of age) with cUTI or AP.

• Phase: Phase 3

Details

• Lead Sponsor: Spero Therapeutics
• Collaborator: GlaxoSmithKline
• Treatments: Cilastatin; Cilastatin, Imipenem Drug Combination; Imipenem