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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: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Sep 2025

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At a glance

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

Most Recent Events

  • 12 Aug 2025 According to a Spero Therapeutics media release, The decrease in research and development expenses compared with the prior year period was primarily due to reduced clinical expenses related to the PIVOT-PO trial.
  • 12 Aug 2025 According to a Spero Therapeutics media release, company, along with development partner, GSK, plans to submit data from the PIVOT-PO trial as part of a planned US Food and Drug Administration (FDA) filing in 2H 2025
  • 12 Aug 2025 According to a Spero Therapeutics media release, PIVOT-POPhase 3 trial evaluating tebipenem Hbr in complicatedurinary tract infection (cUTI) patients stopped early for efficacy following review by independent data monitoring committee (IDMC)

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