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A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens

Trial Profile

A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2022

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At a glance

  • Drugs Cefiderocol (Primary) ; Linezolid; Meropenem
  • Indications Gram-negative infections; Nosocomial pneumonia; Ventilator associated pneumonia
  • Focus Registrational; Therapeutic Use
  • Acronyms APEKS-NP
  • Sponsors Shionogi
  • Most Recent Events

    • 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.
    • 11 Feb 2022 Results from CREDIBLE-CR And APEKS-NP studies published in the Clinical Infectious Diseases
    • 13 Jan 2022 Results of this post-hoc analysis assessing that cefiderocol was non-inferior for 14-day all-cause mortality (ACM) to high-dose, extended-infusion meropenem in critically ill patients with Gram-negative nosocomial pneumonia published in the European Journal of Clinical Microbiology and Infectious Diseases
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