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Clinical Trials in Australia / NCT04538053
Recruiting Phase 4

BonE and Joint Infections - Simplifying Treatment in Children Trial

NCT04538053 · tracked via the Priya Life Science Australia tracker
Sponsor
Murdoch Childrens Research Institute
Phase
Phase 4
Started
2021-06-01
Last updated
2025-11-17

Condition(s) studied

Bone InfectionSeptic ArthritisBone and Joint InfectionOsteomyelitis

Investigational drug(s) / intervention(s)

Oral cefalexin onlyIV cefazolin or IV flucloxacillin followed by oral cefalexin →

Oral cefalexin only: High-dose oral cefalexin

IV cefazolin or IV flucloxacillin followed by oral cefalexin: Standard therapy of IV cefazolin or IV flucloxacillin followed by high dose oral cefalexin

Study 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

Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria. Exclusion Criteria: 1. Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal) 2. Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score) 3. Concomitant severe, invasive infection e.g. necrosing fasciitis 4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal (\>3mm) or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma) 5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins 6. Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection 7. Prior episode of OM or SA 8. Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency) 9. Prior enrolment in the trial 10. Current recipient of another investigational product as part of a clinical trial

Primary outcome measure(s)

  • Proportion of children assessed as having made a full recovery 3 months — 3 months
    Full recovery is defined by the absence of: (i) Clinical features of osteomyelitis or septic arthritis (ii) No episodes of disease recurrence requiring further antibiotic administration after initial treatment. Assessment made by a qualified paediatrician.

Trial sites (10)

FacilityCityRegionStatus
Nepean Hospital Kingswood New South Wales Recruiting
John Hunter Children's Hospital New Lambton Heights New South Wales Recruiting
Sydney Children's Hospital Network Sydney New South Wales Recruiting
The Children's Hospital at Westmead Sydney New South Wales Active Not Recruiting
Royal Darwin Hospital Darwin Northern Territory Recruiting
Queensland Children's Hospital Brisbane Queensland Recruiting
Women's and Children's Hospital Adelaide South Australia Recruiting
The Royal Children's Hospital Melbourne Victoria Recruiting
Perth Children's Hospital Perth Western Australia Recruiting
Christchurch Hospital Christchurch New Zealand Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04538053 on ClinicalTrials.gov ↗ ← All trials in Australia