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.
Phase of Trial: Phase III
Latest Information Update: 26 Mar 2018
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History