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

NCT02334124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2022-11-08

No results posted yet for this study

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?

Conditions

  • Cellulitis

Interventions

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

OTHER

Ward

Admission to a hospital based ward

DRUG

ceftriaxone

50mg/kg once daily

DRUG

flucloxacillin

50mg/kg 6 hourly

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Laila F Ibrahim, MBBChBAO · Royal Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-06-30
Completion
2022-11-30

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02334124 on ClinicalTrials.gov