drugset / Trial / NCT02334124

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

NCT02334124

Completed 190 enrolled Murdoch Childrens Research Institute
RandomizedParallel-groupOpen-labelTreatment

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?

Timeline

Start
2015-01
Primary completion
2017-06
Completion
2022-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceftriaxone Other / unclassified 50 mg/kg Intravenous
Comparator FLOXACILLIN Small molecule 50 mg/kg Intravenous

Indications