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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2019

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At a glance

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

    • 28 Mar 2019 According to an Achaogen media release, the Company has received the Day 120 List of Questions from the European Medicines Agency (EMA) as part of the centralized review process of the MAA for plazomicin.
    • 21 Feb 2019 According to an Achaogen media release, full study results of this trial are published in the New England Journal of Medicine (Letter to the Editor and Supplementary Appendix, 21st Feb 2019, issue of the Journal).
    • 14 Feb 2019 According to an Achaogen media release, in response to the MAA application filed in the fourth quarter of 2018, the Company anticipates receiving the Day 120 questions by the end of the first quarter of 2019, after which it will continue to advance the regulatory process with the rapporteurs and the EMA.
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