Cellulitis Optimal Antibiotic Treatment
A Blinded, Non-inferiority Phase III Trial of 5 Versus 7 Days of Oral Flucloxacillin in Primary Care Patients With Lower Limb Cellulitis
University of Southampton
356 participants
Aug 29, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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
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Interventions
Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by blinded flucloxacillin 500mg for 2 days, reaching a total of 7 days of antibiotic treatment
Patients will be prescribed flucloxacillin 500mg QDS for 5 days followed by a blinded placebo for 2 days, reaching a total of 5 days of antibiotic treatment
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05584007