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

DiscussionThis 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 registrationEU Clinical Trials Register (EudraCT number: 2016-001528-69). Registered on 5 April 2016.ClinicalTrials.gov, ID:NCT02922686. Registered on 9 August 2016.
Source: Trials - Category: Research Source Type: clinical trials