A blinded, non-inferiority phase III trial of 5 versus 7 days of oral flucloxacillin in primary care patients with lower limb cellulitis.
Cellulitis is a deep infection of the skin and subcutaneous tissues and most often occurs in the legs. It is a painful condition that is associated with inflammation and swelling of the site, and often systemic symptoms such as fever, headache, muscle aches, malaise, and fatigue. Patients report feeling unwell and that it has a significant impact on their mobility and ability to carry out their usual activities.
NICE guidelines recommend oral flucloxacillin 500–1000 mg four times daily for 5-7 days as first-line treatment for most patients with cellulitis in the community, but most prescriptions are dispensed for a 7-day course.
Participants will be randomly allocated to one of two groups. In addition to usual care, participants will either be assigned to a 5-day oral flucloxacillin course or a standard 7-day flucloxacillin course. Participants will be prescribed a 5-day course of oral flucloxacillin, and two additional tablets will be posted to the participants which will either be the antibiotic or a placebo. Participants will be asked to fill out daily questionnaires and express their experiences with the shortened course and taking part in the trial.
Primary:
Secondary:
COAT is a randomised, 2-arm, blinded, multi-centre, phase III non-inferiority trial with a 6-month internal pilot.
Following consent participants will be randomised 1:1 into 2 arms:
Participants are then followed up for 28 days via daily questionaries for the first 14 days, then a weekly questionnaire at day 21 and 28. At 12 months post randomisation a primary care notes review will be undertaken.
Open to recruitment
Adults from both genders presenting in primary care with unilateral cellulitis of the leg with the following inclusion criteria:
This trial is funded by the NIHR Health Assessment Program (reference number: NIHR134867)
Senior Trial Manager:
Zina Eminton
Trial Manager:
Sophie Varkonyi-Clifford
Trial Coordinator:
Jemma Turner
Data Manager:
Charlotte Stuart
Phone: 02381 550206
Email: coat@soton.ac.uk
Email: ctu@soton.ac.uk
COAT - Safesend guide for sites, v2 17-Jan-2024
COAT - Site Completion Guidance, v1 22-May-2023
COAT - PIS summary V3 24-feb-2023
COAT - Consent form v4 23-Nov-2023
COAT - eConsent Completion Guidance v1 12-Feb-2024
COAT - Site information text message v1 21-Nov-22
COAT - Participant pack_contact details v2, 12-Oct-2023
COAT - Patient Expression of Interest form v2 19-Jul-2024
COAT - Clinical features at baseline form v1 19-Jul-2024
COAT - Eligibility confirmation form v2 12-Sep-2024
COAT - Participant Day 1 pCRF v6 19-Jul-2024
COAT - Recruitment Guides v1 16-Sep-2024
We have created a series of site training videos for research teams running the COAT study to help staff recruit participants and assess eligibility, and to take you through the CRF data entry process.
Access the videos on our Site Training Resources page.
(University of Southampton cannot accept responsibility for external websites)