Oritavancin vs Vancomycin in Patients with ABSSSI (SOLO I)
Research type
Research Study
Full title
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 I)
IRAS ID
69980
Contact name
Armando Gonzalez
Sponsor organisation
The Medicines Company
Eudract number
2010-021424-94
Clinicaltrials.gov Identifier
Research summary
Acute bacterial skin and skin structure infections (ABSSSI) are common worldwide. The increasing number of methicillin-resistant strains of Staphylococcus aureus (MRSA) and the increase in vancomycin therapeutic failures for strains with increased resistance to vancomycin have necessitated the development of novel agents to treat these infections. Oritavancin is an investigational antibiotic being studied for the treatment of bacterial infections such as skin infections. At the present, oritavancin has not been approved by any drug regulatory agency of any country. This study is Multicenter, Double-Blind and Randomized sponsored by The Medicines Company. The purpose of this study is to look at the effects and safety of a new medicine called oritavancin compared an alternative medicine (vancomycin) for the treatment of ABSSSI. The results of the study will allow for the comparison of the two study drugs (oritavancin or vancomycin) in the treatment of skin infections. It is planned that about 960 patients will be participating in this study, which will be conducted in up to 100 study sites around the world. Participation is expected to last approximately 60 days. The participant will be placed into one of two treatment groups to receive either oritavancin or vancomycin. Study treatment will be administered for a minimum of 7 days and up to a maximum of 10 days. Throughout this period, the participant will receive 2 infusions each day. This study involves clinical examination and procedures including:urine pregnancy test, blood tests, photographs and tracings of the skin infection, pain assessments, ECG, testing a sample oflud or other material from the skin infection and telephone interview. There is a small sub-study being conducted as part of the main study, which requires additional blood samples to be taken for special laboratory tests (Pharmacokinetics).
REC name
London - South East Research Ethics Committee
REC reference
11/LO/1927
Date of REC Opinion
16 Mar 2012
REC opinion
Further Information Favourable Opinion