Oral-only antibiotics for bone and joint infections in children: study protocol for a nationwide randomised open-label non-inferiority trial.
Allan Bybeck Nielsen, Luise Borch, Mads Damkjaer...
https://pubmed.ncbi.nlm.nih.gov/37263683Actively Recruiting
Age: 3Months - 17Years
All Genders
ID06827496
Initial Oral Antibiotics for Bone and Joint Infections in Children A Nationwide Real-World Effectiveness Study in Denmark
Led by Rigshospitalet, Denmark · Updated on 2025-04-09
100
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
I
Innovation Fund Denmark
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the treatment of uncomplicated bone and joint infections (BJI) in children and adolescents. This nationwide, prospective, multicenter real-world cohort study in Denmark aims to compare the effectiveness and safety of initial oral antibiotic therapy with results from a previous randomized controlled trial (RCT). The study focuses on children aged 3 months to 17 years who have uncomplicated BJI without severe symptoms or complications. Participants will receive initial oral antibiotic treatment following Danish Nationwide Guidelines starting in 2024. Children under 5 years are given high-dose amoxicillin-clavulanate, while those 5 years and older receive high-dose anti-staphylococcal penicillin, both with adjusted dosing after clinical improvement. Treatment duration varies by infection type: one week for joint infections, three weeks for bone infections, and four weeks for spondylodiscitis. Patients who had intravenous antibiotics for less than 24 hours before switching to oral antibiotics are also included. During the study, participants will be followed up at 3, 6, and 12 months after treatment start. The three-month visit includes a clinical exam to confirm recovery, while later follow-ups involve telephone interviews or clinical evaluations. Data is collected securely online. The main measure is any lasting movement or function issues in the affected bone or joint after 6 months. Other outcomes include treatment failure within 28 days, full recovery within 3 months, recurrent infections up to 6 months, and long-term complications up to 5 years. Safety is monitored by tracking surgeries and serious complications during antibiotic use.
CONDITIONS
Brief Title
Initial Oral Antibiotics for Bone and Joint Infections in Children
Who Can Participate
Age: 3Months - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 3 months to 17 years
- Diagnosed with uncomplicated bone and joint infections
- Treated with initial oral antibiotics
- Received less than 24 hours of intravenous antibiotics before starting oral treatment
- No severe illness, sepsis, or rapidly progressing symptoms
- No pronounced soft tissue involvement or severe pain
- No foreign material or post-surgical infection
- No infection with resistant or rare pathogens like Salmonella or MRSA
- No severe comorbidities including immunodeficiency
You will not qualify if you...
- Severe illness or signs of sepsis
- Rapid symptom progression
- Pronounced symptoms including severe pain
- Pronounced soft tissue involvement
- Presence of foreign material or post-surgical infection
- Infection with resistant or rare pathogens such as Salmonella or MRSA
- Severe comorbidities including immunodeficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Treatment
Duration - 1 to 4 weeks depending on infection type
Participants receive initial oral antibiotic treatment for uncomplicated bone and joint infections according to age-specific dosing and clinical improvement, with treatment duration depending on infection type.
Visits as part of routine care; specific visit schedule not defined within the trial
Follow-up
Duration - Up to 5 years after treatment ends
Participants are followed up to monitor recovery and any sequelae after treatment completion.
Clinical examination at 3 months; structured telephone interview and/or clinical evaluation at 6 and 12 months; long-term monitoring up to 5 years
Trial Site Locations
Total: 1 location
1
Rigshospitalet
Copenhagen Ø, Denmark, 2100
Actively Recruiting
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Research Team
U
Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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