Comparing short and standard antibiotic courses for leg cellulitis
A Blinded, Non-inferiority Phase III Trial of 5 Versus 7 Days of Oral Flucloxacillin in Primary Care Patients With Lower Limb Cellulitis
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 |
| Enrollment | 356 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southampton Academic / other |
| Locations | 1 site (Southampton) |
| Trial ID | NCT05584007 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with penicillin allergies, bilateral cellulitis, or those requiring immediate hospital admission will not benefit from this study.
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 performed: Previous studies have explored antibiotic treatment durations for cellulitis, but this specific comparison of 5-day versus 7-day courses is novel.
Eligibility criteria
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 this trial is running
Southampton
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.