Simplifying Treatment for Childrens Bone and Joint Infections Comparing Oral Antibiotics Alone to Standard IV Followed by Oral Therapy

What this Trial Is About

Researchers are evaluating treatment options for children aged 1 to 18 years with acute, uncomplicated bone and joint infections BJIs in a multi-center trial across eight major pediatric hospitals in Australia and New Zealand. The study aims to determine if treating these infections entirely with oral antibiotics is not worse than the standard approach, which begins with 1 to 7 days of intravenous IV antibiotics followed by oral antibiotics. The goal is to see if children can fully recover without the need for IV treatment at 3 months after starting therapy. Children in the trial are randomly assigned to one of two groups. One group receives high-dose oral cefalexin four times daily for 1 to 7 days, followed by a standard dose of oral cefalexin three times daily to complete a total 3-week course. The other group receives standard treatment with IV cefazolin or IV flucloxacillin for 1 to 7 days, then oral cefalexin three times daily for 3 weeks. This comparison will help assess whether the oral-only treatment can effectively replace initial IV therapy. Throughout the study, children will be monitored for recovery status at 3 months, including assessment of full recovery, disease recurrence at 6 and 12 months, and any complications or treatment-related side effects. Researchers will also evaluate quality of life using various pediatric health scales, treatment adherence, and cost-effectiveness over 12 months. Medication use and adherence will be reviewed at 3 weeks to understand how well children follow the treatment plan.

BonE and Joint Infections - Simplifying Treatment in Children Trial