Clinical trial Recruiting at 1 site Observational Ages 3 Months to 17

Oral antibiotics for treating bone and joint infections in children

Official title: Initial Oral Antibiotics for Bone and Joint Infections in Children: A Prospective Nationwide Real-world Effectiveness Study in Denmark

Run by Copenhagen University Hospital, Rigshospitalet · NCT06827496 · Data updated 2026-11-12

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.

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Quick facts

Study typeObservational
Ages3 Months to 17 Years
SexAll
Enrollment100 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen Ø)
StatusRecruiting
StartedNovember 15, 2024
Main results expectedNovember 15, 2026
Study endsMay 2027
Registry record updatedApril 9, 2025
Trial IDNCT06827496 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with complicated bone and joint infections or those requiring intravenous antibiotic therapy will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Rigshospitalet
    Copenhagen Ø, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.