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.
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History