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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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 16 Jun 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

  • 28 May 2025 According to a Spero Therapeutics media release,results from this trial will be submitted for presentation at an upcoming scientific congress and for publication in a peer-reviewed journal.
  • 28 May 2025 Interim analysis of data from 1,690 patients presented in the Spero Therapeutics Media Release.
  • 28 May 2025 Status changed from recruiting to discontinued as per a Spero Therapeutics media release.

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