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: 06 Aug 2018

At a glance

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

    • 06 Aug 2018 According to an Achaogen media release, the company plans to submit a Marketing Authorization Application (MAA) to the EMA in H2 2018.
    • 26 Jun 2018 According to an Achaogen media release, the US FDA has issued a Complete Response Letter (CRL) stating that the CARE study does not provide a substantial evidence of effectiveness of plazomicin for the treatment of bloodstream infection (BSI). The Company intends to meet with the FDA to determine whether there is a feasible resolution to address this CRL.
    • 11 Jun 2018 Results of a population pharmacokinetic model of this trial presented at the ASM Microbe 2018
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