Comparing short and standard antibiotic courses for leg cellulitis
Official title: A Blinded, Non-inferiority Phase III Trial of 5 Versus 7 Days of Oral Flucloxacillin in Primary Care Patients With Lower Limb Cellulitis
Run by University of Southampton · NCT05584007 · Data updated 2026-11-12
This study is testing if a 5-day course of antibiotics works just as well as the usual 7-day course for adults with leg cellulitis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 334 (estimated) |
| Sponsor | University of Southampton Academic / other |
| Locations | 1 site (Southampton) |
| Status | Recruiting |
| Started | August 29, 2023 |
| Main results expected | May 2026 |
| Study ends | July 2027 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT05584007 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 years or older with symptoms of cellulitis in one leg for 10 days or less and a pain rating of 3/10 or higher.
✕Probably not a fit
Patients with penicillin allergies, bilateral cellulitis, or those requiring immediate hospital admission will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate whether a 5-day course of oral flucloxacillin is as effective as the standard 7-day course for treating cellulitis of the leg in adults. Participants will be randomly assigned to receive either the shorter or longer antibiotic treatment while also receiving usual care. The study will assess pain levels over a period of days 6-14 post-treatment, as well as the cost implications of the different treatment durations. Participants will complete daily questionnaires to share their experiences and symptoms during the trial.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and cost-efficient treatment for cellulitis, reducing the duration of antibiotic use.
How similar studies have gone: Previous studies have explored antibiotic treatment durations for cellulitis, but this specific comparison of 5-day versus 7-day courses is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Royal South Hants Hospital
Southampton, United Kingdom Recruiting
Study contacts
- Study coordinator: Sophie Varkonyi-Clifford
- Email: coat@soton.ac.uk
- Phone: 0 23 8059 1532
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.