A Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infections suspected or confirmed to be due to Gram-positive pathogens. REVIVE-2

Trial Profile

A Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infections suspected or confirmed to be due to Gram-positive pathogens. REVIVE-2

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2018

At a glance

  • Drugs Iclaprim (Primary) ; Vancomycin
  • Indications Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms REVIVE-2
  • Sponsors Motif Bio
  • Most Recent Events

    • 19 Apr 2018 Results presented in a Motif Bio Media Release.
    • 03 Apr 2018 According to a Motif Bio media release, rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for iclaprim for the treatment of acute bacterial skin and skin structure infections (ABSSSI) has been initiated, and expected to be completed during the second quarter of 2018.
    • 20 Mar 2018 According to a Motif Bio media release, the Company now expects to submit the NDA to the FDA during the second quarter of 2018.
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