Comparing the Intravenous Treatment of Skin Infections in Children, Home Versus Hospital
CHOICE
CHOICE Trial: Cellulitis at Home Or Inpatient in Children From ED
1 other identifier
interventional
190
1 country
1
Brief Summary
Many children every year present to the Emergency Department (ED) at The Royal Children's Hospital (RCH) with cellulitis (skin infection). If it is mild, the children can go home with oral antibiotic treatment. If it is complicated and severe, these children are admitted to hospital for intravenous (IV, through a drip) antibiotic treatment. There is a middle group with uncomplicated moderate/severe cellulitis who require IV antibiotics but who are not acutely unwell. In order to determine whether it is just as effective for children with uncomplicated moderate to severe cellulitis to receive antibiotic treatment at home (via Hospital-In-The-Home) as it is to receive antibiotic treatment in hospital, there is a need to conduct a larger study and randomly assign children to receive either HITH or hospital ward care. The primary research question to be addressed is: In children with moderate/severe uncomplicated cellulitis, is the failure rate at 2 days following the first dose of antibiotic non-inferior for children treated with IV antibiotics at home compared to the failure rate at 2 days following the first dose for children treated with IV antibiotics in hospital?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 4, 2015
CompletedFirst Posted
Study publicly available on registry
January 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedNovember 8, 2022
November 1, 2022
2.4 years
January 4, 2015
November 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment failure (inadequate clinical improvement, adverse event)
The primary outcome is failure of treatment defined as no clinical improvement of cellulitis within 2 days of treatment from the start of the first antibiotic dose given in the ED. Any change of initial empiric antibiotics within 2 days from commencement due to: * inadequate clinical improvement or * adverse events as determined by treating physician will be considered a treatment failure.
Within 2 days of commencing empiric antibiotic
Secondary Outcomes (13)
Time to no progression
Within 3 days
Time to discharge
14 days
Readmission rate
28 days
Representation to ED
28 days
ED Length of stay
2 days
- +8 more secondary outcomes
Other Outcomes (1)
Microbiome
1 year
Study Arms (2)
Home
EXPERIMENTALPatients will be treated at home through the Hospital-In-The-Home program with intravenous once daily ceftriaxone (50mg/kg once daily), administered by a nurse/doctor visiting once daily.
Ward
ACTIVE COMPARATORPatients will be admitted to hospital ward and treated with six hourly flucloxacillin (50mg/kg), administered by a ward nurse as per routine practice.
Interventions
The main intervention is for children with uncomplicated cellulitis to remain at home throughout the period of intravenous treatment but as it is not feasible to administer flucloxacillin four times a day by the Hospital-In-The-Home team, once daily ceftriaxone is the most ideal antibiotic to be given to this group
Eligibility Criteria
You may qualify if:
- Children aged 6 months to 18 years
- Children presenting to RCH ED with moderate/severe cellulitis
- Moderate/severe: defined in this study, as those assessed by ED clinician to need IV antibiotics
- Reasons for starting IV antibiotics include:
- Failed oral therapy (not improving despite 24h of oral therapy)
- Rapidly spreading redness (from patient/parent history)
- Significant swelling/redness/pain
- Systemic symptoms/signs (eg. fever, lethargy)
- Difficult to treat areas (eg. face, ear, toe)
You may not qualify if:
- Children will be excluded:
- With orbital cellulitis or unable to exclude orbital cellulitis,
- With penetrating injury/bites,
- With suspected fasciitis or myositis,
- With toxicity: tachycardia when afebrile or hypotension (both as per the limits set out by RCH Resuscitation Card), poor central perfusion (capillary refill \>2 seconds)
- With immunosuppression,
- With varicella,
- With suspected/confirmed foreign body,
- With abscess not drained,
- With dental abscess,
- With concurrent sinusitis or otitis media or lymphadenitis necessitating different antibiotic treatment to flucloxacillin monotherapy or ceftriaxone monotherapy,
- With liver co-morbidities
- With other medical diagnoses warranting admission to hospital for observation or treatment relating to the known medical condition
- With difficult intravenous access,
- Age \<6 months old,
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Royal Children's Hospital Melbourne
Parkville, Victoria, 3072, Australia
Related Publications (3)
Ibrahim LF, Huang L, Hopper SM, Dalziel K, Babl FE, Bryant PA. Intravenous ceftriaxone at home versus intravenous flucloxacillin in hospital for children with cellulitis: a cost-effectiveness analysis. Lancet Infect Dis. 2019 Oct;19(10):1101-1108. doi: 10.1016/S1473-3099(19)30288-9. Epub 2019 Aug 13.
PMID: 31420292DERIVEDIbrahim LF, Hopper SM, Orsini F, Daley AJ, Babl FE, Bryant PA. Efficacy and safety of intravenous ceftriaxone at home versus intravenous flucloxacillin in hospital for children with cellulitis (CHOICE): a single-centre, open-label, randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2019 May;19(5):477-486. doi: 10.1016/S1473-3099(18)30729-1. Epub 2019 Mar 7.
PMID: 30853250DERIVEDIbrahim LF, Babl FE, Orsini F, Hopper SM, Bryant PA. Cellulitis: Home Or Inpatient in Children from the Emergency Department (CHOICE): protocol for a randomised controlled trial. BMJ Open. 2016 Jan 11;6(1):e009606. doi: 10.1136/bmjopen-2015-009606.
PMID: 26754176DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laila F Ibrahim, MBBChBAO
Royal Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Laila Ibrahim, MBBChBAO, PhD Student
Study Record Dates
First Submitted
January 4, 2015
First Posted
January 8, 2015
Study Start
January 1, 2015
Primary Completion
June 1, 2017
Study Completion
November 1, 2022
Last Updated
November 8, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share