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 Friedman1*, Pollard James1,2, Huffam Sarah1, Walton Aaron L1, O’Brien Daniel P1, Cowan Raquel U1, Lim Karen1, Lane Stephen E3, Sarah Alana J4, Chambers Jo4, Gay Caroline L4, Simpson Paul E1, Hughes Andrew J1 and Athan Eugene1|
|1Department of Infectious Diseases, Barwon Health, Geelong, Victoria, 3220 Australia|
|2Hospital in the Home Service, Barwon Health, Geelong, Victoria, 3220 Australia|
|3Biostatistics Unit, Clinical trial unit, Barwon Health, Geelong, Victoria, 3220 Australia|
|4Department of Medicine, Barwon Health, Geelong, VIC, 3220 Australia|
|Corresponding Author :||Dr. N Deborah Friedman MBBS
FRACP, MD, MPH,Principal Research Fellow
and Infectious Diseases Physician
Barwon Health, Geelong, VIC, Australia
Tel: (03) 42152033
E-mail: [email protected]
|Received August 20, 2014; Accepted December 04, 2014; Published December 10, 2014|
|Citation: Deborah FN, James P, Sarah H, Aaron LW, Daniel PO, et al. (2014) Randomized Controlled Trial of Short Course Intravenous Therapy for Cellulitis and Erysipelas of the Lower Limb (Switch): Study Protocol and Pilot Trial Results. J Clin Trials 4:200. doi:10.4172/2167-0870.1000200|
|Copyright: © 2014 Deborah FN, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.|
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.