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
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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
- Acute, uncomplicated, community-acquired bone and joint infection
- Fulfill pre-defined clinical criteria for the infection
You will not qualify if you...
- Infection caused by bacteria resistant to cefalexin or atypical infections such as mycobacterial or fungal
- Presence of sepsis with organ dysfunction as defined by Pediatric Logistic Organ Dysfunction-2 score
- Severe invasive infections like necrotising fasciitis
- Complicated infections including prosthetic material, large subperiosteal or soft tissue abscess without surgery, or infections related to trauma
- Allergy to cephalosporin antibiotics or severe immediate reactions to penicillins
- More than three doses of IV or oral antibiotics received for the current infection
- Previous episode of osteomyelitis or septic arthritis
- Conditions causing poor absorption or complicated disease such as inflammatory bowel disease or immunodeficiency
- Prior participation in this trial
- Currently receiving another investigational product in a clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 7 days of initial antibiotics followed by 3 weeks of oral antibiotics
Participants receive either high-dose oral antibiotics alone or initial IV antibiotics followed by oral antibiotics for bone and joint infections.
Weekly visits for up to 4 weeks
Duration - Up to 12 months
Participants are assessed for recovery, recurrence, complications, quality of life, treatment adherence, and adverse effects after treatment completion.
Visits at 3 weeks, 3 months, 6 months, and 12 months
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
A
Amanda Gwee, PhD
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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