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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2023

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At a glance

  • Drugs Tedizolid (Primary) ; Tedizolid (Primary) ; Linezolid; Linezolid
  • Indications Gram-positive infections; Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ESTABLISH-2
  • Sponsors Trius Therapeutics

    • Most Recent Events

    • 12 May 2019 This trial has been completed in Spain as per European Clinical Trials Database record.
    • 01 Dec 2018 Results of post-hoc pooled subgroup analysis of ESTABLISH and ESTABLISH-2 trials (n=1333) assessing efficacy and safety published in the Infectious Diseases and Therapy.
    • 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

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