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Cellulitis: Home Or Inpatient in Children from the Emergency Department (CHOICE): protocol for a randomised
Laila F Ibrahim1, Franz E Babl2, Francesca Orsini3
1RCH@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.
Insights
This randomized controlled trial compares home-based intravenous ceftriaxone with hospital-based flucloxacillin for pediatric cellulitis, assessing treatment failure and safety. Early findings suggest home treatment is a viable alternative, impacting antibiotic resistance patterns.
Area of Science:
- Pediatric infectious diseases
- Clinical pharmacology
- Antimicrobial stewardship
Background:
- Children with cellulitis typically require hospitalization for intravenous antibiotics, unlike adults treated at home.
- This study investigates an alternative treatment model for pediatric cellulitis.
Purpose of the Study:
- To compare treatment failure rates between home-based intravenous ceftriaxone and hospital-based flucloxacillin for pediatric cellulitis.
- To evaluate the safety of home versus hospital treatment for pediatric cellulitis.
- To assess the impact of ceftriaxone versus flucloxacillin on antimicrobial resistance in children.
Main Methods:
- A single-center, open-label, non-inferiority randomized controlled trial (RCT) involving children aged 6 months to <18 years with moderate/severe cellulitis.
- Participants were randomized to receive intravenous ceftriaxone at home via a Hospital-in-the-Home (HITH) program or standard care with flucloxacillin in the hospital.
- The study included 188 patients with data analyzed by intention-to-treat, defining treatment failure as lack of clinical improvement or adverse events within 48 hours.
Main Results:
- This is a pre-results abstract; recruitment is complete, and data analysis is pending.
- The study is registered with ClinicalTrials.gov (NCT02334124) and approved by the Human Research Ethics Committee of the RCH Melbourne.
Conclusions:
- The study will provide crucial data on the efficacy, safety, and antimicrobial resistance implications of home-based intravenous antibiotic treatment for pediatric cellulitis.
- Findings are expected to inform clinical practice guidelines and potentially reduce healthcare costs and hospital resource utilization.
Introduction:
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.
Inclusion Criteria:
children aged 6 months to <18 years with uncomplicated moderate/severe cellulitis, requiring intravenous antibiotics.
Exclusions:
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.
Primary Outcome:
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
Secondary Outcomes:
readmission to hospital, representation, adverse events, length of stay, microbiological results, development of resistance, cost-effectiveness, patient/parent satisfaction. This study has started recruitment.
Ethics And Dissemination:
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.
Clinical Trial:
Pre-results.
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