Journal of Clinical Trials
Open Access

Abstract

Randomized Controlled Trial of Short Course Intravenous Therapy for Cellulitis and Erysipelas of the Lower Limb (Switch): Study Protocol and Pilot Trial Results

Deborah N Friedman, Pollard James, Huffam Sarah, Walton Aaron L, O’Brien Daniel P, Cowan Raquel U, Lim Karen, Lane Stephen E, Sarah Alana J, Chambers Jo, Gay Caroline L, Simpson Paul E, Hughes Andrew J and Athan Eugene

Study background: Cellulitis and erysipelas are common skin and soft tissue infections. Antibiotics are the mainstay of therapy, but to date there is no consensus on whether intravenous or oral therapy are optimal choices, and the suggested duration of therapy.
Methods: In a randomized non-inferiority, parallel trial, consecutive eligible adult patients will be randomized by random block allocation to the intervention arm of 24 hours IV therapy versus ≥ 72 hours IV therapy (both followed by oral therapy to total duration of 10 days). Antibiotics used are anti-staphylococcal penicillins and first generation cephalosporins.
Resolution of cellulitis is defined by; resolution of fever, lack of progression of the involved area at 48-72 hours, and lack of requirement for antibiotics beyond the study period of 10 days.
Secondary outcome measures include; pain in the affected limb, return to normal mobility, blinded photographic assessment, adverse events, and recurrence of infection within 30 days. A cost effectiveness analysis will also be undertaken.
Results: Over a 12-month period from November 2012, 243 patients were screened for participation in the SWITCH pilot trial. Forty patients were recruited (16%) and 203 patients (84%) fulfilled one or more exclusion criteria. Patients were excluded based on having received ≥48 hours IV antibiotics prior to presentation, an alternative diagnosis and an unwillingness to participate.
20 patients were randomized to ≥72 hours IV therapy; 19 successfully responded to therapy and 1 case withdrew prematurely. 20 cases were randomized to 24 hours IV therapy; 17 responded successfully and 3 withdrew prematurely.
Conclusions: This pilot randomized trial of short course therapy for cellulitis has determined that such a trial is safe and feasible. Recruitment may be affected by many conditions that are mislabeled as cellulitis or represent non-acute pre-treated cellulitis. This non-inferiority trial will now expand to multiple sites in 2014.