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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jul 2017

At a glance

  • Drugs Oritavancin (Primary) ; Vancomycin
  • Indications Bacterial infections; Methicillin-resistant Staphylococcus aureus infections; Skin and soft tissue infections
  • Focus Registrational; Therapeutic Use
  • Acronyms SOLO-1; SOLO-I
  • 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.
    • 06 Aug 2014 A decision from the European Commission is expected during the first half of 2015, according to a Medicines Company media release.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top