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A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem 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, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2023

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At a glance

  • Drugs Tebipenem pivoxil (Primary) ; Ertapenem
  • Indications Pyelonephritis; Urinary tract infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ADAPT-PO
  • Sponsors Spero Therapeutics

Most Recent Events

  • 19 Oct 2022 According to a Spero Therapeutics media release, data from this will be presented at the Infectious Disease Society of America (IDSA) IDWeek™ 2022.
  • 06 Sep 2022 According to a Spero Therapeutics media release, during the Type A meeting, the FDA indicated that positive results from a single additional Phase 3 clinical trial supported by confirmatory nonclinical evidence of efficacy could be sufficient to support the approval of tebipenem HBr for the treatment of cUTI, including pyelonephritis for a limited use indication.
  • 06 Sep 2022 According to a Spero Therapeutics media release, the company provided an update on its tebipenem HBr program following the receipt of minutes from a recent Type A meeting with the U.S. Food and Drug Administration (FDA), discussing steps required for resubmission of the New Drug Application (NDA) for tebipenem HBr for the treatment of complicated urinary tract infection (cUTI), including pyelonephritis.

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