title: Cellulitis: Home Or Inpatient in Children from the Emergency Department (CHOICE): protocol for a randomised controlled trial.
abstract: BACKGROUND
  Children needing intravenous antibiotics for cellulitis are usually admitted to hospital, whereas adults commonly receive intravenous treatment at home. This is a randomised controlled trial (RCT) of intravenous antibiotic treatment of cellulitis in children comparing administration of ceftriaxone at home with standard care of flucloxacillin in hospital. The study aims to compare (1) the rate of treatment failure at home versus hospital (2) the safety of treatment at home versus hospital; and (3) the effect of exposure to short course ceftriaxone versus flucloxacillin on nasal and gut micro-organism resistance patterns and the clinical implications.
  
  
  METHODS
  
  
  
  METHODS
  children aged 6 months to <18 years with uncomplicated moderate/severe cellulitis, requiring intravenous antibiotics.
  
  
  METHODS
  complicated cellulitis (eg, orbital, foreign body) and immunosuppressed or toxic patients. The study is a single-centre, open-label, non-inferiority RCT. It is set in the emergency department (ED) at the Royal Children's Hospital (RCH) in Melbourne, Australia and the Hospital-in-the-Home (HITH) programme; a home-care programme, which provides outreach from RCH. Recruitment will occur in ED from January 2015 to December 2016. Participants will be randomised to either treatment in hospital, or transfer home under the HITH programme. The calculated sample size is 188 patients (94 per group) and data will be analysed by intention-to-treat.
  
  
  METHODS
  treatment failure defined as a change in treatment due to lack of clinical improvement according to the treating physician or adverse events, within 48 h
  
  
  RESULTS
  readmission to hospital, representation, adverse events, length of stay, microbiological results, development of resistance, cost-effectiveness, patient/parent satisfaction. This study has started recruitment.
  
  
  BACKGROUND
  This study has been approved by the Human Research Ethics Committee of the RCH Melbourne (34254C) and registered with the ClinicalTrials.gov registry (NCT02334124). We aim to disseminate the findings through international peer-reviewed journals and conferences.
  
  
  BACKGROUND
  Pre-results.
authors.affiliation: RCH@Home Department, The Royal Children's Hospital, Parkville, Victoria, Australia Murdoch Children's Research Institute, Parkville, Victoria, Australia Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Laila F
authors.initials: LF
authors.lastname: Ibrahim
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia Emergency Department, The Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Franz E
authors.initials: FE
authors.lastname: Babl
authors.affiliation: Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia.
authors.forename: Francesca
authors.initials: F
authors.lastname: Orsini
authors.affiliation: Murdoch Children's Research Institute, Parkville, Victoria, Australia Emergency Department, The Royal Children's Hospital, Parkville, Victoria, Australia.
authors.forename: Sandy M
authors.initials: SM
authors.lastname: Hopper
authors.affiliation: Infectious Diseases Unit, Department of General Medicine, The Royal Children's Hospital, Parkville, Victoria, Australia RCH@Home Department, The Royal Children's Hospital, Parkville, Victoria, Australia Murdoch Children's Research Institute, Parkville, Victoria, Australia Department of Paediatrics, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Penelope A
authors.initials: PA
authors.lastname: Bryant
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001315:Australia; D002443:Ceftriaxone / Q000627:therapeutic use*; D002481:Cellulitis / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004351:Drug Resistance; D004636:Emergency Service, Hospital; D005436:Floxacillin / Q000627:therapeutic use*; D006699:Home Care Services; D006760:Hospitalization; D006801:Humans; D007223:Infant; D010359:Patient Readmission; D010361:Patients; D012107:Research Design; D059039:Standard of Care; D017211:Treatment Failure
chemical_list: D000900:Anti-Bacterial Agents; D005436:Floxacillin; D002443:Ceftriaxone
keywords: ACCIDENT & EMERGENCY MEDICINE