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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)

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Trial Profile

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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2025

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At a glance

  • Drugs Tebipenem pivoxil (Primary) ; Imipenem/cilastatin
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PIVOT-PO
  • Sponsors Spero Therapeutics

Most Recent Events

  • 27 Mar 2025 According to a Spero Therapeutics media release, pre-specified interim analysis of Phase 3 PIVOT-PO clinical trial of tebipenem HBr in complicated urinary tract infection (cUTI) is expected to be completed in Q2 2025
  • 10 Jan 2025 According to a Spero Therapeutics media release, the trial reaches Over 60% Enrollment as of December 31, 2024; Remains on Track to Complete Enrollment in 2H 2025
  • 12 Sep 2024 Planned End Date changed from 1 Dec 2025 to 1 Nov 2025.

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