RecruitingPhase 3

Cellulitis Optimal Antibiotic Treatment

United Kingdom334 participantsStarted 2023-08-29

Plain-language summary

To determine whether a short course of oral flucloxacillin (5 days) is non-inferior to a standard course (7 days) in terms of pain over days 6-14 (indicative of persistence or recurrence associated with the symptoms of most importance to patients) in adults with cellulitis of the leg presenting in primary care.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Must be aged 18 years or older * Currently showing symptoms of cellulitis (such as pain, tenderness, redness, other change in skin color, warmth to touch) in one leg for 10 days or less * Pain rated as 3/10 or higher on a numerical rating scale (0-10) at baseline assessment * Be willing to be randomized to either trial arm (5-day or 7-day treatment) * Able to complete trial procedures in the English language. Exclusion Criteria: * Have penicillin allergy * Have bilateral cellulitis * Have had antibiotics for cellulitis within the past month * Have post-operative cellulitis (within 30 days of operative procedures on the same leg) * Have cellulitis resulting from human/animal bite injury * Have Cellulitis associated with chronic (\>6 weeks) leg ulceration * Require immediate hospital admission or out-patient intravenous antibiotic therapy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain assessment

Timeframe: Days 7-16

Trial details

NCT IDNCT05584007

SponsorUniversity of Southampton

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Sophie Varkonyi-Clifford

0 23 8059 1532 coat@soton.ac.uk

View on ClinicalTrials.gov More Cellulitis of Leg trials