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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02334124




Registration number
NCT02334124
Ethics application status
Date submitted
4/01/2015
Date registered
8/01/2015
Date last updated
8/11/2022

Titles & IDs
Public title
Comparing the Intravenous Treatment of Skin Infections in Children, Home Versus Hospital
Scientific title
CHOICE Trial: Cellulitis at Home Or Inpatient in Children From ED
Secondary ID [1] 0 0
HREC34254F
Universal Trial Number (UTN)
Trial acronym
CHOICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Home
Other interventions - Ward
Treatment: Drugs - ceftriaxone
Treatment: Drugs - flucloxacillin

Experimental: Home - Patients 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.

Active comparator: Ward - Patients will be admitted to hospital ward and treated with six hourly flucloxacillin (50mg/kg), administered by a ward nurse as per routine practice.


Other interventions: Home
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

Other interventions: Ward
Admission to a hospital based ward

Treatment: Drugs: ceftriaxone
50mg/kg once daily

Treatment: Drugs: flucloxacillin
50mg/kg 6 hourly
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment failure (inadequate clinical improvement, adverse event)
Timepoint [1] 0 0
Within 2 days of commencing empiric antibiotic
Secondary outcome [1] 0 0
Time to no progression
Timepoint [1] 0 0
Within 3 days
Secondary outcome [2] 0 0
Time to discharge
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Readmission rate
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Representation to ED
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
ED Length of stay
Timepoint [5] 0 0
2 days
Secondary outcome [6] 0 0
Duration of iv antibiotics
Timepoint [6] 0 0
14 days
Secondary outcome [7] 0 0
IV cannula resiting (Rates of iv cannula needing at least one resiting)
Timepoint [7] 0 0
14 days
Secondary outcome [8] 0 0
Complications of cellulitis (Development of abscess requiring drainage)
Timepoint [8] 0 0
14 days
Secondary outcome [9] 0 0
Adverse events
Timepoint [9] 0 0
14 days
Secondary outcome [10] 0 0
Comparing patient costs
Timepoint [10] 0 0
14 days
Secondary outcome [11] 0 0
Quality of life (QOL) indicators
Timepoint [11] 0 0
1 year
Secondary outcome [12] 0 0
Cellulitis clinical score
Timepoint [12] 0 0
14 days
Secondary outcome [13] 0 0
Microbiology
Timepoint [13] 0 0
1 year

Eligibility
Key inclusion criteria
* 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:

1. Failed oral therapy (not improving despite 24h of oral therapy)
2. Rapidly spreading redness (from patient/parent history)
3. Significant swelling/redness/pain
4. Systemic symptoms/signs (eg. fever, lethargy)
5. Difficult to treat areas (eg. face, ear, toe)
Minimum age
6 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be excluded:

1. With orbital cellulitis or unable to exclude orbital cellulitis,
2. With penetrating injury/bites,
3. With suspected fasciitis or myositis,
4. 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)
5. With immunosuppression,
6. With varicella,
7. With suspected/confirmed foreign body,
8. With abscess not drained,
9. With dental abscess,
10. With concurrent sinusitis or otitis media or lymphadenitis necessitating different antibiotic treatment to flucloxacillin monotherapy or ceftriaxone monotherapy,
11. With liver co-morbidities
12. With other medical diagnoses warranting admission to hospital for observation or treatment relating to the known medical condition
13. With difficult intravenous access,
14. Age <6 months old,
15. Who could be managed on oral antibiotics (ie assessed as mild cellulitis)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2022
Sample size
Target
Accrual to date
Final
190
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
3072 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT02334124
Trial related presentations / publications
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.
Ibrahim 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.
Ibrahim 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.
Public notes

Contacts
Principal investigator
Name 0 0
Laila F Ibrahim, MBBChBAO
Address 0 0
The Royal Children's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02334124