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A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO II)

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Trial Profile

A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO II)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2021

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At a glance

  • Drugs Oritavancin (Primary) ; Vancomycin
  • Indications Bacterial infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SOLO-2; SOLO-II
  • Sponsors The Medicines Company

    • Most Recent Events

    • 01 Sep 2016 Results of post-hoc pooled analysis (n=1910) assessing the efficay of SOLO trials (SOLO I and SOLO II) by using Eron severity and management setting, published in the Infectious Diseases and Therapy Journal.
    • 30 Mar 2015 According to a media release from The Medicines Company, the EC has granted marketing authorization for oritavancin [Orbactiv], followed by positive opinion by the CHMP of the EMA.
    • 09 Oct 2014 According to The Medicines Company media release, results were published in the Clinical Infectious Diseases.

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