Oral antibiotics for treating bone and joint infections in children
Initial Oral Antibiotics for Bone and Joint Infections in Children: A Prospective Nationwide Real-world Effectiveness Study in Denmark
This study is testing if giving oral antibiotics first can effectively and safely treat uncomplicated bone and joint infections in children and teens aged 3 months to 17 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 3 Months to 17 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen Ø) |
| Trial ID | NCT06827496 on ClinicalTrials.gov |
What this trial studies
This nationwide, prospective, multicenter cohort study aims to evaluate the effectiveness and safety of initial oral antibiotic treatment for children and adolescents aged 3 months to 17 years with uncomplicated bone and joint infections. The study will compare real-world outcomes of these patients with those who received oral antibiotics in a previous randomized controlled trial. Conducted across 18 Pediatric Departments in Denmark, the study will include 100 participants treated with oral antibiotics from 2024 to 2026. The goal is to provide insights into the real-world application of oral antibiotics in this patient population.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 3 months to 17 years with uncomplicated bone and joint infections who are treated with initial oral antibiotics.
Not a fit: Patients with complicated bone and joint infections or those requiring intravenous antibiotic therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting the use of oral antibiotics as a safe and effective treatment option for children with uncomplicated bone and joint infections.
How similar studies have performed: Previous studies have shown that initial oral antibiotics can be non-inferior to intravenous antibiotics, but this study aims to further validate these findings in a real-world setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Children and adolescents aged 3 months to 17 years with uncomplicated bone and joint infections treated with initial oral antibiotics. According to Danish Nationwide Guidelines (initiated in 2024), initial oral antibiotics are recommended to patients with no risk factors for complicated disease. Risk factors include for complicated disease include: 1. Severe illness or sepsis 2. Rapid symptom progression 3. Pronounced symptoms, including severe pain 4. Pronounced soft tissue involvement 5. Foreign material or post-surgical infection 6. Infection with a resistent or rare pathogen, e.g., Salmonella or MRSA 7. Severe comorbidity, including immunodeficiency Patients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included
Where this trial is running
Copenhagen Ø
- Rigshospitalet — Copenhagen Ø, Denmark (Recruiting)
Study contacts
- Study coordinator: Ulrikka Nygaard, Ass Professor, PhD, MD, MPhil
- Email: Ulrikka.Nygaard@regionh.dk
- Phone: +45 35459761
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.