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Comparing the Intravenous Treatment of Skin Infections in Children, Home Versus Hospital (CHOICE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02334124
First Posted: January 8, 2015
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Laila Ibrahim, Murdoch Childrens Research Institute
  Purpose

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?


Condition Intervention
Cellulitis Other: Home Other: Ward Drug: ceftriaxone Drug: flucloxacillin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHOICE Trial: Cellulitis at Home Or Inpatient in Children From ED

Resource links provided by NLM:


Further study details as provided by Laila Ibrahim, Murdoch Childrens Research Institute:

Primary Outcome Measures:
  • Treatment failure (inadequate clinical improvement, adverse event) [ Time Frame: Within 2 days of commencing empiric antibiotic ]

    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.


Secondary Outcome Measures:
  • Time to no progression [ Time Frame: Within 3 days ]
    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

  • Time to discharge [ Time Frame: 14 days ]

    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)


  • Readmission rate [ Time Frame: 28 days ]
    Number of children readmitted to hospital within 14 days of discharge date due to the same cellulitis

  • Representation to ED [ Time Frame: 28 days ]
    Number of children representing to ED within 14 days of discharge and diagnosed to have incomplete resolution or recurrence of same cellulitis

  • ED Length of stay [ Time Frame: 2 days ]
    Length of stay in ED (from first presentation in ED to time the patient leaves ED to go either home or to ward)

  • Duration of iv antibiotics [ Time Frame: 14 days ]
    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

  • IV cannula resiting (Rates of iv cannula needing at least one resiting) [ Time Frame: 14 days ]
    Rates of iv cannula needing at least one resiting

  • Complications of cellulitis (Development of abscess requiring drainage) [ Time Frame: 14 days ]
    Development of abscess requiring drainage after starting IV antibiotics and bacteremia

  • Adverse events [ Time Frame: 14 days ]
    Occurrences of anaphylaxis, allergic reaction (suspected or confirmed) necessitating change of empiric antibiotic, sepsis, death

  • Comparing patient costs [ Time Frame: 14 days ]
    Comparing ward patient costs and HITH patient costs

  • Quality of life (QOL) indicators [ Time Frame: 1 year ]
    Quality of life (QOL) indicators (through survey asking parents/patients how much admission to hospital or HITH disrupt their routine)

  • Cellulitis clinical score [ Time Frame: 14 days ]
    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).

  • Microbiology [ Time Frame: 1 year ]
    • 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.


Other Outcome Measures:
  • Microbiome [ Time Frame: 1 year ]
    • Differential effect of narrow spectrum (flucloxacillin) and broad spectrum (ceftriaxone) on the nasal and gastrointestinal microbiome from nasal swabs and stool samples collected within 48 hours, after 7-14 days, 3 months and 1 year after starting antibiotics. This outcome will be published separately.


Enrollment: 190
Study Start Date: January 2015
Estimated Study Completion Date: May 2018
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: 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
Drug: ceftriaxone
50mg/kg 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: Ward
Admission to a hospital based ward
Drug: flucloxacillin
50mg/kg 6 hourly

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334124


Locations
Australia, Victoria
The Royal Children's Hospital Melbourne
Parkville, Victoria, Australia, 3072
Sponsors and Collaborators
Murdoch Childrens Research Institute
Investigators
Principal Investigator: Laila F Ibrahim, MBBChBAO The Royal Children's Hospital Melbourne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laila Ibrahim, Dr Laila Ibrahim, MBBChBAO, PhD Student, Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT02334124     History of Changes
Other Study ID Numbers: HREC34254D
First Submitted: January 4, 2015
First Posted: January 8, 2015
Last Update Posted: August 31, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cellulitis
Skin Diseases, Infectious
Infection
Suppuration
Connective Tissue Diseases
Inflammation
Pathologic Processes
Ceftriaxone
Floxacillin
Anti-Bacterial Agents
Anti-Infective Agents