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01.12.2017 | Update | Ausgabe 1/2017 Open Access

Trials 1/2017

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

Zeitschrift:
Trials > Ausgabe 1/2017
Autoren:
Fiona Boland, Michael Quirke, Brenda Gannon, Sinead Plunkett, John Hayden, John McCourt, Ronan O’Sullivan, Joseph Eustace, Conor Deasy, Abel Wakai
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-017-2121-2) contains supplementary material, which is available to authorized users.

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.

Trial registration

EU Clinical Trials Register (EudraCT number: 2016-001528-69). Registered on 5 April 2016.
ClinicalTrials.gov, ID: NCT02922686. Registered on 9 August 2016.
Zusatzmaterial
Additional file 1: Case Report Form (CRF). Contains a paper version of the electronic case report form (eCRF) which will be used in the PEDOCELL trial. (DOCX 445 kb)
13063_2017_2121_MOESM1_ESM.docx
Additional file 2: Health-related quality of life (HRQoL) questionnaires. The HRQoL questionnaires to be used in the PEDOCELL trial are to be found in Additional File 2. The EQ-5D-5L, the SF-12 and the Extremity Soft Tissue Infection (ESTI) score will be used to measure HRQoL outcomes in patients enrolled to the PEDOCELL trial at each follow-up visit. (DOCX 86 kb)
13063_2017_2121_MOESM2_ESM.docx
Additional file 3: Health resource use questionnaires. The health resource use questionnaires will be completed at the baseline visit, early clinical response visit, end of treatment visit, test of cure visit and any unscheduled visit. The results of these questionnaires will contribute to the pharmacoeconomic analysis for the PEDOCELL trial. (DOCX 123 kb)
13063_2017_2121_MOESM3_ESM.docx
Literatur
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