A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

Trial Profile

A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2018

At a glance

  • Drugs Plazomicin (Primary) ; Colistin
  • Indications Bacteraemia; Enterobacteriaceae infections; Gram-negative infections; Nosocomial pneumonia; Pyelonephritis; Urinary tract infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CARE
  • Sponsors Achaogen
  • Most Recent Events

    • 10 Apr 2018 According to an Achaogen media release, company and its collaborators will deliver one mini-oral at the 28th European Congress of Clinical Microbiology and Infectious Disease (ECCMID).
    • 21 Mar 2018 According to an Achaogen media release, the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has planned a meeting on 2 May 2018 to review the NDA for plazomicin for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment option.
    • 02 Jan 2018 According to an Achaogen media release, Based on the data from EPIC and CARE trials, the US FDA has accepted for review the Company's NDA for plazomicin for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis and bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options. FDA has granted the NDA Priority Review and set a target action date under PDUFA of June 25, 2018.
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