RecruitingPhase 3NCT05584007

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

Sponsor

University of Southampton

Enrollment

334 participants

Start Date

Aug 29, 2023

Study Type

INTERVENTIONAL

Conditions

Cellulitis of Leg

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Flucloxacillin Only Product in Oral Dose Form and a drug called Placebo Only Product in Oral Dose Form for people with cellulitis of leg. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFlucloxacillin Only Product in Oral Dose Form

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

DRUGPlacebo Only Product in Oral Dose Form

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)

Royal South Hants Hospital

Southampton, United Kingdom

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NCT05584007