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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Murdoch Childrens Research Institute
• Treatments: Ceftriaxone; Floxacillin

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)