Cellulitis Optimal Antibiotic Treatment - COAT
Research type
Research Study
Full title
Cellulitis Optimal Antibiotic Treatment Trial
IRAS ID
1006161
Contact name
Nick Francis
Contact email
Sponsor organisation
University of Southampton
ISRCTN Number
ISRCTN27053187
Clinicaltrials.gov Identifier
Research summary
Cellulitis is a common deep skin infection. It happens most often in the legs because of bacterial infection. It is a painful condition with tenderness and swelling of the leg area, and often symptoms such as a temperature, headache, muscle aches, and tiredness. People report feeling unwell and that it has a significant impact on their mobility and ability to carry out their usual activities. National guidelines recommend treatment with a common oral antibiotic called flucloxacillin for 5 Most people are treated with 7 days of antibiotics, but 5-day courses may work just as well, as the guidelines suggest.
Some studies have found short courses of antibiotics to be as effective as longer courses, but for cellulitis no trials have been conducted in primary care and no trials have compared different treatment courses of flucloxacillin.
Our aim in this study is to compare 5 days of flucloxacillin with 7 days of flucloxacillin for adults with cellulitis in their leg. We want to make sure that the shorter course does not result in more pain or complications. We also want to compare overall use of antibiotics, side effects, costs and other impacts for patients. We will do this by giving all participants 5 days of flucloxacillin and randomly assigning them to take 2 more days of either flucloxacillin or a placebo, which is a dummy pill that looks like flucloxacillin.
So, the patients who volunteer to take part in the study will take flucloxacillin for either 5 days or 7 days. We will then ask them to report pain, use of antibiotics and other outcomes over 4 weeks. We will also ask them for permission to check their medical record over the following 12 months to see if they develop complications or further episodes of cellulitis. The study will recruit 356 patients from up to 40 GP practices across the UK.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0021
Date of REC Opinion
19 Jun 2023
REC opinion
Further Information Favourable Opinion