Actively Recruiting
A Blinded, Non-inferiority Trial Comparing 5 Versus 7 Days of Oral Flucloxacillin for Lower Limb Cellulitis in Primary Care
Led by University of Southampton · Updated on 2026-05-15
334
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
U
University of Southampton
Lead Sponsor
U
University of East Anglia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a shorter 5-day course of oral flucloxacillin is not worse than the standard 7-day course for treating cellulitis of the leg in adults seen in primary care. Cellulitis is a painful skin and tissue infection often accompanied by swelling, redness, and systemic symptoms like fever and fatigue. This study aims to compare pain levels during days 6-14 after starting treatment, which reflects ongoing or recurring symptoms important to patients. Participants are randomly assigned to one of two groups: one receives flucloxacillin 500mg four times daily for 5 days followed by placebo for 2 days, while the other receives flucloxacillin 500mg four times daily for the full 7 days, with the last 2 days blinded. This quadruple-blind study involves usual care plus the assigned treatment course, and it will also assess the cost implications of the shorter treatment from NHS and personal perspectives. During the trial, participants will complete daily questionnaires about their symptoms and experiences. Researchers will measure pain from days 7 to 16, quality of life, leg swelling and warmth, recovery time, hospital admissions, and recurrence of cellulitis over 12 months. Safety and complications will be monitored throughout. The total study duration extends up to 12 months for follow-up.
CONDITIONS
Brief Title
Cellulitis Optimal Antibiotic Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be aged 18 years or older
- Have symptoms of cellulitis in one leg for 10 days or less
- Have pain rated 3 out of 10 or higher at the start
- Willing to be randomly assigned to either 5-day or 7-day treatment
- Able to complete trial procedures in English
You will not qualify if you...
- Allergy to penicillin
- Cellulitis affecting both legs
- Taken antibiotics for cellulitis in the past month
- Post-operative cellulitis within 30 days of surgery on the same leg
- Cellulitis caused by a human or animal bite
- Cellulitis linked to chronic leg ulcers lasting more than 6 weeks
- Need immediate hospital admission or intravenous antibiotic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 7 days
Participants receive either a 5-day or 7-day course of oral flucloxacillin to treat lower limb cellulitis. They will take medication daily and complete daily questionnaires about their symptoms and experiences.
Daily medication and daily questionnaires during treatment
Duration - Up to 12 months
Participants are monitored for recovery, symptoms, and any complications through day 28, with assessments including pain, swelling, and quality of life. Long-term monitoring of hospital admissions and recurrent cellulitis episodes continues up to 12 months.
Assessments on Days 7, 14, 21, 28 and long-term monitoring up to 12 months
Trial Site Locations
Total: 1 location
1
Royal South Hants Hospital
Southampton, United Kingdom
Actively Recruiting
Research Team
S
Sophie Varkonyi-Clifford
E
Ella Bourke
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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