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)
Phase of Trial: Phase III
Latest Information Update: 08 Jul 2017
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History