A Phase 3, Randomized, Double Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-resistant Staphylococcus Aureus.
Phase of Trial: Phase III
Latest Information Update: 08 Jun 2016
At a glance
- Drugs Telavancin (Primary) ; Vancomycin
- Indications Gram-positive infections; Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections
- Focus Registrational; Therapeutic Use
- Acronyms ATLAS-I
- 09 May 2016 According to a Theravance Biopharma media release, the US FDA has approved the company's sNDA for VIBATIV (telavancin) to expand the product's label to include data describing the treatment of patients with concurrent Staphylococcus aureus bacteremia in both of the antibiotic's currently approved indications in the United States (HABP/VABP). The sNDA was approved based on combined data from the ATLAS I and II and ATTAIN I and II trials.
- 10 Sep 2015 According to Theravance Biopharma media release, the US FDA has accepted for filing the company's supplemental NDA.
- 30 Jun 2015 According to Theravance Biopharma media release, telavancin (VIBATIV) has receieved marketing authorization in Russia for the treatment of multiple infections caused by gram positive bacteria including MRSA.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History