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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

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: 27 Apr 2020

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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

    • 27 Apr 2020 According to a Shionogi media release, the European Commission (EC) has granted a marketing authorisation for cefiderocol for the treatment of infections due to aerobic Gram-negative bacteria in adults (18 years or older) with limited treatment options, based on data from non-clinical data and the PK/PD package (including in vitro data) and supported by three clinical studies (CREDIBLE-CR, APEKS-cUTI and APEKS-NP).
    • 02 Mar 2020 According to a Shionogi media release, the European Commission will review the CHMP opinion and is expected to deliver its final decision later this year.
    • 02 Mar 2020 According to a Shionogi media release, Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of FETCROJA (cefiderocol), a new antibiotic for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options.This positive opinion was supported by the clinical data submitted from three key studies: CREDIBLE-CR, APEKS-cUTI and APEKS-NP
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