Clinical Trial: Comparing the Intravenous Treatment of Skin Infections in Children, Home Versus Hospital

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: CHOICE Trial: Cellulitis at Home Or Inpatient in Children From ED

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?

Detailed Summary:

INTRODUCTION AND BACKGROUND Adults with cellulitis commonly have IV antibiotics administered as outpatients, whereas most children are admitted to hospital. Based on a small amount of literature, it is known that some children with moderate/severe cellulitis can also be safely be treated at home.This study will include all children with uncomplicated moderate/severe cellulitis and will therefore demonstrate whether all children with uncomplicated moderate/severe cellulitis can be effectively treated at home.

If the study demonstrates that it is just as effective to treat these children in the home, it has the potential to impact on the child and family's quality of life (QOL) as well as hospital resource management.

PRIMARY OBJECTIVE To compare the failure rate of IV antibiotic treatment of children treated at home (iv ceftriaxone) with those treated in hospital (iv flucloxacillin) in the first 2 days of treatment following the first dose given in the ED in children with moderate/severe cellulitis (Moderate/severe: defined in this study, as those assessed by ED doctor to need iv antibiotics)

SECONDARY OBJECTIVES

To compare:

Time to no progression of cellulitis Time to discharge: number of days (including fractions of days) from the time of arrival in ED to the time the patient no longer needs hospital-based interventions/care, whether in hospital or at home Readmission rate Representation to ED Length of stay in ED Duration of IV antibiotics Rates of IV cannula needing at least one resiting Complications of cellulitis: development of abscess requiring drainage after starting IV antibiotics, bacteraemia Adverse events

Microbiol
Sponsor: Murdoch Childrens Research Institute

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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.

Original Secondary Outcome:

• 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 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).

Dates:
Date Received: January 4, 2015
Date Started: January 2015
Date Completion: May 2018
Last Updated: April 4, 2017
Last Verified: April 2017