Phase 3 Study Comparing 5-Day Versus 7-Day Oral Flucloxacillin Treatment for Leg Cellulitis in Adults

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.

Cellulitis Optimal Antibiotic Treatment