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: 31 Aug 2022
Price :
$35
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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
- 29 Aug 2022 Results of an analysis assessed the Desirability of outcome ranking (DOOR) approach application to Improving traditional registrational trial endpoints applied to three registrational drug trials (ZEUS, APEKS-cUTI, and DORI-05) published in the Clinical Infectious Diseases
- 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.
- 02 Dec 2020 Results assessing safety and efficacay from CREDIBLE - CR and APEKS-CUTI and efficacy from APEKS-NP, published in the Clinical Infectious Diseases