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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02334124
Ethics application status
Date submitted
4/01/2015
Date registered
8/01/2015
Date last updated
25/02/2020

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
HREC34254E
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) - 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.
Timepoint [1] 0 0
Within 2 days of commencing empiric antibiotic
Secondary outcome [1] 0 0
Time to no progression - Number of days (including fractions of days) elapsed from the start of the first dose in ED (Day 1) to the time at which the cellulitis stops spreading past the marked area, judged during daily assessment of cellulitis
Timepoint [1] 0 0
Within 3 days
Secondary outcome [2] 0 0
Time to discharge - Number of days (including fractions of days) elapsed from the time of arrival in ED to the moment the patient is discharged.
(Discharge is defined as when patients admitted to hospital are deemed not to require any hospital funded care/intervention from a hospital based nurse/doctor. The time and date is registered on the electronic hospital database IBA. Admission to hospital is defined as patients who are deemed to need hospital funded care/intervention from a hospital based nurse/doctor)
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
Readmission rate - Number of children readmitted to hospital within 14 days of discharge date due to the same cellulitis
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Representation to ED - Number of children representing to ED within 14 days of discharge and diagnosed to have incomplete resolution or recurrence of same cellulitis
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
ED Length of stay - Length of stay in ED (from first presentation in ED to time the patient leaves ED to go either home or to ward)
Timepoint [5] 0 0
2 days
Secondary outcome [6] 0 0
Duration of iv antibiotics - Number of days (including fractions of days) elapsed from the start of the first dose in ED (Day 1) to the time of the last dose
Timepoint [6] 0 0
14 days
Secondary outcome [7] 0 0
IV cannula resiting (Rates of iv cannula needing at least one 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) - Development of abscess requiring drainage after starting IV antibiotics and bacteremia
Timepoint [8] 0 0
14 days
Secondary outcome [9] 0 0
Adverse events - Occurrences of anaphylaxis, allergic reaction (suspected or confirmed) necessitating change of empiric antibiotic, sepsis, death
Timepoint [9] 0 0
14 days
Secondary outcome [10] 0 0
Comparing patient costs - Comparing ward patient costs and HITH patient costs
Timepoint [10] 0 0
14 days
Secondary outcome [11] 0 0
Quality of life (QOL) indicators - Quality of life (QOL) indicators (through survey asking parents/patients how much admission to hospital or HITH disrupt their routine)
Timepoint [11] 0 0
1 year
Secondary outcome [12] 0 0
Cellulitis clinical score - Clinical assessment in all study participants in terms of presence of systemic features, surface area affected (longest length axis multiply by the longest perpendicular axis measured in cm2), severity of swelling (judged by clinician as any one of the following: mild, moderate or severe), intensity of erythema (judged by clinician from a scale of 0 to 5, 0=no erythema and 5=severe erythema), impairment of function of affected area, tenderness of cellulitis area (judged by clinician from a scale of 0 to 5, 0=not tender and 5=very tender).
Timepoint [12] 0 0
14 days
Secondary outcome [13] 0 0
Microbiology - Rate of ceftriaxone susceptibility in bacteria isolated from a nasal or skin swab of the affected area
Rate of S. aureus nasal carriage (methicillin-sensitive and methicillin-resistant) collected within 48 hours, after 7-14 days, 3 months and 1 year after starting antibiotics
Rate of resistant bacteria present in stool samples collected within 48 hours, after 7-14 days, 3 months and 1 year after starting antibiotics. Rates of clinical infection with resistant organisms up to 1 year after starting antibiotics. This outcome may be published separately as require longer follow up.
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT02334124
Trial related presentations / publications
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
Other publications