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.author Boland, Fiona
dc.contributor.author Quirke, Michael
dc.contributor.author Gannon, Brenda
dc.contributor.author Plunkett, Sinead
dc.contributor.author Hayden, John
dc.contributor.author McCourt, John
dc.contributor.author O'Sullivan, Ronan
dc.contributor.author Eustace, Joseph A.
dc.contributor.author Deasy, Conor
dc.contributor.author Wakai, Abel
dc.date.accessioned 2017-09-26T11:39:23Z
dc.date.available 2017-09-26T11:39:23Z
dc.date.issued 2017
dc.identifier.citation Boland, 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/s13063-017-2121-2 en
dc.identifier.volume 18
dc.identifier.issn 1745-6215
dc.identifier.uri http://hdl.handle.net/10468/4809
dc.identifier.doi 10.1186/s13063-017-2121-2
dc.description.abstract Background: 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.sponsorship Health Research Board (HRA-DI-2015-1297) en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Biomed Central Ltd en
dc.relation.uri https://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.uri https://creativecommons.org/licenses/by/4.0/
dc.subject CELLulitis en
dc.subject Wound infection en
dc.subject Abscess en
dc.subject Flucloxacillin en
dc.subject Phenoxymethylpenicillin en
dc.subject Randomised controlled trial en
dc.subject Emergency department en
dc.subject Statistical analysis plan en
dc.subject Skin structure infections en
dc.subject Uncomplicated skin en
dc.subject Noninferiority en
dc.subject Placebo en
dc.title The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP) en
dc.type Article (peer-reviewed) en
dc.internal.availability Full text available en
dc.description.version Published Version en
dc.internal.wokid WOS:000408675800001
dc.contributor.funder Health Research Board
dc.description.status Peer reviewed en
dc.identifier.journaltitle Trials en
dc.internal.IRISemailaddress j.eustace@ucc.ie en
dc.identifier.articleid 391


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© 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. Except where otherwise noted, this item's license is described as © 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.
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