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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Sep 2019

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At a glance

  • Drugs Telavancin (Primary) ; Vancomycin
  • Indications Gram-positive infections; Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections; Surgical wound infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ATLAS-II
  • Sponsors Cumberland Pharmaceuticals; Theravance
  • Most Recent Events

    • 01 Sep 2017 Results of post hoc analysis of data from the ATLAS and ATTAIN trials assessing efficacy and safety of Telavancin in patients with Concurrent Staphylococcus aureus Bacteremia, were published in the Infectious Diseases and Therapy.
    • 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.
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