Oral flucloxacillin and phenoxymethylpenicillin versus flucloxacillin alone for the emergency department outpatient treatment of cellulitis: study protocol for a randomised controlled trial

Trials

Ronan O’Sullivan³  Peadar Gilligan¹  Abel Wakai²  Michael Quirke² 

[1] Emergency Department, Beaumont Hospital, PO Box 1297, Beaumont Road, Dublin 9, Ireland;Division of Population Health Sciences (PHS), Emergency Care Research Unit (ECRU), Royal College of Surgeons in Ireland, 123 St. Stephens Green, Dublin 2, Ireland;Department of Emergency Medicine, Cork University Hospital, Wilton, Cork, Ireland

关键词: Emergency department;    Double blind;    Randomised controlled trial;    Oral;    Penicillin V;    Phenoxymethylpenicillin;    Flucloxacillin;    Adult;    Cellulitis;   

Others  :  1093775
DOI  :  10.1186/1745-6215-14-164

 received in 2013-02-21, accepted in 2013-05-17,  发布年份 2013

【 摘 要 】

Background

Oral flucloxacillin, either alone or in combination with phenoxymethylpenicillin, is a commonly prescribed antibiotic for the treatment of cellulitis, particularly in Ireland and the United Kingdom. This study aims to establish the non-inferiority of oral monotherapy (flucloxacillin alone) to dual therapy (flucloxacillin and phenoxymethylpenicillin) for the outpatient treatment of cellulitis in adults.

Methods/design

This study is a multicentre, randomised, double-blind, placebo-controlled trial of adults who present to the emergency department (ED) with cellulitis that is deemed treatable on an outpatient basis with oral antibiotics. After fulfilling specified inclusion and exclusion criteria, informed consent will be taken. Patients will be given a treatment pack containing 7 days of treatment with flucloxacillin 500 mg four times daily and placebo or flucloxacillin 500 mg four times daily and phenoxymethylpenicillin 500 mg four times daily. The primary outcome measure under study is the proportion of patients in each group in which there is greater than or equal to a 50% reduction in the area of diameter of infection from the area measured at enrolment at the end-of-treatment visit (7 to 10 days). Secondary endpoints include a health-related quality of life measurement as rated by the SF-36 score and the Extremity Soft Tissue Infection Score (not validated), compliance and adverse events. Patients will be followed up by telephone call at 3 days, end-of-treatment visit (EOT) at 7 to 10 days and test-of-cure (TOC) visit at 30 days. To achieve 90% power, a sample size of 172 patients per treatment arm is needed. This assumes a treatment success rate of 85% with oral flucloxacillin and phenoxymethylpenicillin, an equivalence threshold Δ = 12.5% and an α = 0.025. Non-inferiority will be assessed using a one-sided confidence interval on the difference of proportions between the two groups. Standard analysis including per-protocol and intention-to-treat will be performed.

Discussion

This trial aims to establish the non-inferiority of flucloxacillin monotherapy to dual therapy in the treatment of uncomplicated cellulitis among ED patients. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines.

Trial registration

EudraCT Number2008-006151-42

【 授权许可】

   
2013 Quirke et al.; licensee BioMed Central Ltd.

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