Observational study looking at management of skin infection
Research type
Research Study
Full title
An observational research study to describe current management of acute bacterial skin and skin structure infections (ABSSSI) in the UK and the impact of the introduction of tedizolid
IRAS ID
182639
Contact name
Armando Gonzalez
Contact email
Sponsor organisation
Merck Sharp and Dohme Corp
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
An acute bacterial skin and skin structure infection (ABSSSI) is a bacterial infection of the skin and surrounding tissues in which the area of affected skin is more than 75 square centimetres. ABSSSIs often require treatment with antibiotics. A new antibiotic called tedizolid has recently been introduced; this has been shown to work just as well as some of the existing antibiotics, but has the potential to be used over shorter treatment periods. Infection control is a priority for the NHS and as new treatments are introduced into clinical practice, it is important to understand current management of ABSSSIs.
This study will help to improve understanding about the different medications that are currently used to treat ABSSSIs, the number of infections managed in real-world practice and the impact on the healthcare system. It will also provide some information about the impact of tedizolid, for hospitals that have already introduced it into their service.
This is a non-interventional research study of up to 500 patients with ABSSSIs caused by certain types of bacteria who are receiving hospital treatment. It will be conducted in approximately 10 UK hospitals. Patients will be identified prospectively as they begin their treatment. The study will involve collecting data about patients and their ABSSSI both prospectively (by the patient’s direct care team during routine care provision) and retrospectively from patients’ medical records (by members of the direct care team or trained external researchers). Where external researchers are collecting data from medical records, patients will provide written informed consent for a researcher to access their medical records. Where all data collection will be completed by members of the direct care team, patient consent will not be obtained. All data collected for the study will reflect procedures, tests and assessments done in normal clinical practice as and when required.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
15/LO/1249
Date of REC Opinion
12 Oct 2015
REC opinion
Further Information Favourable Opinion