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




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Trials

, 14:164

First Online: 03 June 2013Received: 21 February 2013Accepted: 17 May 2013DOI: 10.1186-1745-6215-14-164

Cite this article as: Quirke, M., Wakai, A., Gilligan, P. et al. Trials 2013 14: 164. doi:10.1186-1745-6215-14-164

Abstract

BackgroundOral 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-designThis 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.

DiscussionThis 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 registrationEudraCT Number2008-006151-42

KeywordsCellulitis Adult Flucloxacillin Phenoxymethylpenicillin Penicillin V Oral Randomised controlled trial Double blind Emergency department AbbreviationsAEAdverse event

CA-MRSACommunity acquired methicillin resistant Staphylococcus aureus

CIConfidence interval

CSTARCentre for support and training in analysis and research

CRESTClinical resource efficiency support team

EDEmergency department

EOTEnd-of-treatment

GCPGood clinical practice

GPGeneral practitioner

HRECHealth research ethics committee

IMBIrish medicines board

ITTIntention to treat

LOSLength of stay

NHSNational health service

PIPrincipal investigator

SAESerious adverse event

SNOSESequentially numbered opaque sealed envelope

SOPStandard operating procedure

SSTISkin and soft tissue infection

SUSARSuspected unexpected serious adverse reaction

TOCTest-of-cure.

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Autor: Michael Quirke - Abel Wakai - Peadar Gilligan - Ronan O’Sullivan

Fuente: https://link.springer.com/







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