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-1

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-1

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Iclaprim (Primary) ; Vancomycin
  • Indications Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms REVIVE-1
  • Sponsors Motif Bio
  • Most Recent Events

    • 09 Aug 2017 According to a Motif Bio media release,successful results from the two REVIVE trials are expected to satisfy both US FDA and EMA requirements for regulatory submission for intravenous iclaprim in the treatment of ABSSSI. NDA Submission is anticipated in the first half of 2018.
    • 22 Jun 2017 According to a Motif Bio media release, data from this trial will be presented during the formal Symposia session at IDWeek 2017.
    • 18 Apr 2017 Results published in the Media Release
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