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RECRUITING
NCT04538053
PHASE4

BonE and Joint Infections - Simplifying Treatment in Children Trial

Sponsor: Murdoch Childrens Research Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

1 Year - 18 Years

Study Type

INTERVENTIONAL

Enrollment

285

Start Date

2021-06-01

Completion Date

2026-12

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

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

Locations (10)

Nepean Hospital

Kingswood, New South Wales, Australia

John Hunter Children's Hospital

New Lambton Heights, New South Wales, Australia

Sydney Children's Hospital Network

Sydney, New South Wales, Australia

The Children's Hospital at Westmead

Sydney, New South Wales, Australia

Royal Darwin Hospital

Darwin, Northern Territory, Australia

Queensland Children's Hospital

Brisbane, Queensland, Australia

Women's and Children's Hospital

Adelaide, South Australia, Australia

The Royal Children's Hospital

Melbourne, Victoria, Australia

Perth Children's Hospital

Perth, Western Australia, Australia

Christchurch Hospital

Christchurch, New Zealand