Actively Recruiting
BonE and Joint Infections - Simplifying Treatment in Children Trial
Led by Murdoch Childrens Research Institute · Updated on 2025-11-17
285
Participants Needed
10
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BonE and Joint Infections - Simplifying Treatment in Children Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.
You will not qualify if you...
- Infection caused by bacteria resistant to cefalexin or by atypical infections such as mycobacterial or fungal infections
- Signs of sepsis defined by organ dysfunction according to the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score
- Presence of a severe, invasive infection like necrosing fasciitis
- Complicated infection including prosthetic material, large subperiosteal (>3mm) or soft tissue abscess without surgery, or infection linked to trauma
- History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
- Received more than three doses of intravenous or oral antibiotics active against the likely bacteria causing the current infection
- Previous episode of osteomyelitis or septic arthritis
- Existing conditions causing poor absorption (e.g., inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease such as immunodeficiency
- Prior participation in this trial
- Currently receiving another investigational product as part of a clinical trial
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Actively Recruiting
2
John Hunter Children's Hospital
New Lambton Heights, New South Wales, Australia, 2305
Actively Recruiting
3
Sydney Children's Hospital Network
Sydney, New South Wales, Australia, 2031
Actively Recruiting
4
The Children's Hospital at Westmead
Sydney, New South Wales, Australia, 2145
Active, Not Recruiting
5
Royal Darwin Hospital
Darwin, Northern Territory, Australia, 0811
Actively Recruiting
6
Queensland Children's Hospital
Brisbane, Queensland, Australia, 4101
Actively Recruiting
7
Women's and Children's Hospital
Adelaide, South Australia, Australia, 5006
Actively Recruiting
8
The Royal Children's Hospital
Melbourne, Victoria, Australia, 3051
Actively Recruiting
9
Perth Children's Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
10
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
Research Team
A
Alison Boast, MD
CONTACT
A
Amanda Gwee, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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