A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10 Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.

Trial Profile

A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10 Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections.

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2017

At a glance

  • Drugs Tedizolid (Primary) ; Linezolid
  • Indications Gram-positive infections; Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ABSSSI; ESTABLISH-1
  • Sponsors Trius Therapeutics
  • Most Recent Events

    • 06 Mar 2017 Results of subgroup analysis of pooled efficacy data from two phase III trials (ESTABLISH-1 and ESTABLISH-2) published in the Antimicrobial Agents and Chemotherapy
    • 28 Apr 2015 Results of pooled analysis of ESTABLISH-1 and ESTABLISH-2 trials presented at the 25th European Congress of Clinical Microbiology and Infectious Diseases.
    • 27 Feb 2014 Results from this trial are expected to support a New Drug Submission to Health Canada according to a Cubist Pharmaceuticals media release. The submission is expected to occur during the first half of 2014.
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