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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: 16 Jan 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

    • 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.
    • 15 May 2024 According to a Spero Therapeutics media release, As of March 31, 2024, Spero had cash and cash equivalents of $82.3 million, compared to $76.3 million at December 31, 2023. The increase in the cash balance was a result of the receipt of $23.8 million milestone payment from GSK, the first of four equal tranches of the $95.0 million development milestones that Spero earned upon first patient enrollment in the tebipenem HBr Phase 3 PIVOT-PO trial. The increase was partially offset by cash operating

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