drugset / Trial / NCT04538053
BonE and Joint Infections - Simplifying Treatment in Children Trial
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.
Timeline
- Start
- 2021-06-01
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CEPHALEXIN ANHYDROUS | Small molecule | 45 mg/kg | Oral |
| Comparator | Cefazolin | Small molecule | 50 mg/kg | Intravenous |
| Comparator | FLOXACILLIN | Small molecule | 50 mg/kg | Intravenous |