NCT04538053

BonE and Joint Infections - Simplifying Treatment in Children Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 285 (estimated)
• Sponsor: Murdoch Childrens Research Institute · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Children with acute onset BJIs who present to the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'standard treatment group' will receive standard treatment for BJIs, which consists of IV antibiotics for 1-7 days followed by 3 weeks of oral antibiotics. Children in the 'entirely oral treatment group' will receive high dose oral antibiotics, followed by the standard dose of oral antibiotics for 3 weeks. The outcomes of children in each of the two groups will be compared to determine whether BJIs can be treated without needing a course of IV antibiotics.

Conditions

• Bone Infection
• Septic Arthritis
• Bone and Joint Infection
• Osteomyelitis

Interventions

Type	Name	Description
DRUG	Oral cefalexin only	High-dose oral cefalexin
DRUG	IV cefazolin or IV flucloxacillin followed by oral cefalexin	Standard therapy of IV cefazolin or IV flucloxacillin followed by high dose oral cefalexin

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-09-03
• Last updated: 2025-11-17

Locations

10 sites across 2 countries: Australia, New Zealand