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: 26 Oct 2017

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

    • 26 Oct 2017 According to an Achaogen media release, based on the data from EPIC and CARE trials, the company has submitted a NDA to the U.S. FDA 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.
    • 08 Oct 2017 Results (n=39) comparing outcomes with plazomicin and Colistin in patient subgroup with Carbapenem-resistant Enterobacteriaceae bloodstream infections presented at the IDWeek 2017.
    • 05 Oct 2017 According to an Achaogen media release, data will be presented at the Infectious Diseases Society of America (IDSA) IDWeek 2017.
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