Phase 3, randomized, investigator-blind, multi-center study to evaluate efficacy and safety of intravenous iclaprim [Arpida] versus linezolid in complicated skin and skin structure infections

Trial Profile

Phase 3, randomized, investigator-blind, multi-center study to evaluate efficacy and safety of intravenous iclaprim [Arpida] versus linezolid in complicated skin and skin structure infections

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2015

At a glance

  • Drugs Iclaprim (Primary) ; Linezolid
  • Indications Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ASSIST-1
  • Sponsors Evolva Holding SA
  • Most Recent Events

    • 26 Oct 2008 Results were presented at the 48th Interscience Conference on Antimicrobial Agents and Chemotherapy and 46th Annual Meeting of the Infectious Diseases Society of America, according to a Arpida media release.
    • 01 Sep 2008 Data from this trial used to support a New Drug Submission to the Therapeutic Products Directorate of Health Canada, according to an Arpida media release.
    • 21 Aug 2008 Data from this trial is included in the Marketing Authorisation Application (MAA) for iclaprim, according to a Arpida media release.
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