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A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

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Trial Profile

A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Apr 2025

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At a glance

  • Drugs Cefiderocol (Primary) ; Amikacin; Avibactam/ceftazidime; Ceftolozane/tazobactam; Ciprofloxacin; Doripenem; Fosfomycin; Gentamicin; Tigecycline; Tobramycin
  • Indications Acinetobacter infections; Enterobacter infections; Escherichia coli infections; Gram-negative infections; Klebsiella infections; Nosocomial pneumonia; Pseudomonal infections; Sepsis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CREDIBLE - CR
  • 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.
  • 20 Feb 2022 Results of post-hoc analysis of two studies (APEKS-cUTI (NCT02321800), APEKS-NP (NCT03032380) and CREDIBLE-CR (NCT02714595)) assessing cefiderocol efficacy in patients with baseline bacteraemia published in the Infectious Diseases and Therapy.

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