The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP)

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dc.contributor.authorBoland, Fiona
dc.contributor.authorQuirke, Michael
dc.contributor.authorGannon, Brenda
dc.contributor.authorPlunkett, Sinead
dc.contributor.authorHayden, John
dc.contributor.authorMcCourt, John
dc.contributor.authorO'Sullivan, Ronan
dc.contributor.authorEustace, Joseph A.
dc.contributor.authorDeasy, Conor
dc.contributor.authorWakai, Abel
dc.contributor.funderHealth Research Board
dc.date.accessioned2017-09-26T11:39:23Z
dc.date.available2017-09-26T11:39:23Z
dc.date.issued2017
dc.description.abstractBackground: Cellulitis is a painful, potentially serious, infectious process of the dermal and subdermal tissues and represents a significant disease burden. The statistical analysis plan (SAP) for the Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial is described here. The PEDOCELL trial is a multicentre, randomised, parallel-arm, double-blinded, non-inferiority clinical trial comparing the efficacy of flucloxacillin (monotherapy) with combination flucloxacillin/phenoxymethylpenicillin (dual therapy) for the outpatient treatment of cellulitis in the emergency department (ED) setting. To prevent outcome reporting bias, selective reporting and data-driven results, the a priori-defined, detailed SAP is presented here. Methods/design: Patients will be randomised to either orally administered flucloxacillin 500 mg four times daily and placebo or orally administered 500 mg of flucloxacillin four times daily and phenoxymethylpenicillin 500 mg four times daily. The trial consists of a 7-day intervention period and a 2-week follow-up period. Study measurements will be taken at four specific time points: at patient enrolment, day 2-3 after enrolment and commencing treatment (early clinical response (ECR) visit), day 8-10 after enrolment (end-of-treatment (EOT) visit) and day 14-21 after enrolment (test-of-cure (TOC) visit). The primary outcome measure is investigator-determined clinical response measured at the TOC visit. The secondary outcomes are as follows: lesion size at ECR, clinical treatment failure at each follow-up visit, adherence and persistence of trial patients with orally administered antibiotic therapy at EOT, health-related quality of life (HRQoL) and pharmacoeconomic assessments. The plan for the presentation and comparison of baseline characteristics and outcomes is described in this paper. Discussion: This trial aims to establish the non-inferiority of orally administered flucloxacillin monotherapy with orally administered flucloxacillin/phenoxymethylpenicillin dual therapy for the ED-directed outpatient treatment of cellulitis. 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. The SAP for the PEDOCELL trial was developed a priori in order to minimise analysis bias.en
dc.description.sponsorshipHealth Research Board (HRA-DI-2015-1297)en
dc.description.statusPeer revieweden
dc.description.versionPublished Versionen
dc.format.mimetypeapplication/pdfen
dc.identifier.articleid391
dc.identifier.citationBoland, F., Quirke, M., Gannon, B., Plunkett, S., Hayden, J., McCourt, J., O’Sullivan, R., Eustace, J., Deasy, C. and Wakai, A. (2017) 'The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP)', Trials, 18(1), 391 (9pp). doi: 10.1186/s13063-017-2121-2en
dc.identifier.doi10.1186/s13063-017-2121-2
dc.identifier.issn1745-6215
dc.identifier.journaltitleTrialsen
dc.identifier.urihttps://hdl.handle.net/10468/4809
dc.identifier.volume18
dc.language.isoenen
dc.publisherBiomed Central Ltden
dc.relation.urihttps://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2121-2
dc.rights© 2017, the Authors. Open Access. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/
dc.subjectCELLulitisen
dc.subjectWound infectionen
dc.subjectAbscessen
dc.subjectFlucloxacillinen
dc.subjectPhenoxymethylpenicillinen
dc.subjectRandomised controlled trialen
dc.subjectEmergency departmenten
dc.subjectStatistical analysis planen
dc.subjectSkin structure infectionsen
dc.subjectUncomplicated skinen
dc.subjectNoninferiorityen
dc.subjectPlaceboen
dc.titleThe Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP)en
dc.typeArticle (peer-reviewed)en
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