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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: 14 Nov 2019

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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

    • 14 Nov 2019 According to a Shionogi media release, based on data from this pivotal (APEKS-cUTI) study, the U.S. FDA has approved FETROJA (cefiderocol) for patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae.
    • 16 Oct 2019 According to a Shionogi media release,the U.S. FDA Antimicrobial Drugs Advisory Committee voted to recommend approval of the cefiderocol for the treatment of complicated urinary tract infections, including pyelonephritis, in patients with limited or no alternative treatment options. The assigned action date is November 14, 2019 under the Prescription Drug User-Fee Act (PDUFA).
    • 26 May 2019 This trial has been completed in Croatia.
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