RecruitingPhase 4NCT04538053

BonE and Joint Infections - Simplifying Treatment in Children Trial

Sponsor

Murdoch Childrens Research Institute

Enrollment

285 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

Septic arthritis Osteomyelitis Bone and Joint Infection Bone Infection

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.

Eligibility

Min Age: 1 YearMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IV cefazolin or IV flucloxacillin followed by oral cefalexin and a drug called Oral cefalexin only for people with bone infection, bone and joint infection, and other related conditions. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 1 Year to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral cefalexin only

High-dose oral cefalexin

DRUGIV 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

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NCT04538053

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