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

Completed
Phase of Trial: Phase II

Latest Information Update: 17 Jul 2017

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

    • 01 Jun 2017 According to a Shionogi media release, based on the data from this study, the company plans to submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in 2017.
    • 25 Apr 2017 Results presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases
    • 17 Apr 2017 According to a Shionogi media release, results from this trial will be presented at European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) 2017.
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