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A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin

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Trial Profile

A Multicenter, Double-blind, Randomized, Clinical Study to Assess the Efficacy and Safety of Intravenous S-649266 in Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis Caused by Gram-Negative Pathogens in Hospitalized Adults in Comparison with Intravenous Imipenem/Cilastatin

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Apr 2025

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At a glance

  • Drugs Cefiderocol (Primary) ; Imipenem/cilastatin
  • Indications Gram-negative infections; Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms APEKs-cUTI
  • Sponsors Shionogi

Most Recent Events

  • 02 Apr 2025 According to a Shionogi media release, The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol in December 2024 and the application is under evaluation. The acceptance of this application is based on the results obtained from APEKS-cUTI, CREDIBLE-CR and APEKS-NP.
  • 21 Feb 2025 According to a Shionogi media release, the company announced that JEIL PHARMACEUTICAL CO., LTD its partner in South Korea has obtained marketing approval from the South Korean regulatory authorities for the gram-negative bacterial infection treatment "Fetroja"(cefiderocol) (hereafter "Fetroja"). The approval is based on the data of APEKS-cUTI, CREDIBLE-CR and APEKS-NP studies.
  • 29 Aug 2022 Results of an analysis assessed the Desirability of outcome ranking (DOOR) approach application to Improving traditional registrational trial endpoints applied to three registrational drug trials (ZEUS, APEKS-cUTI, and DORI-05) published in the Clinical Infectious Diseases

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