Study of Oral Antibiotics for Bone and Joint Infections in Children and Adolescents A Nationwide Real-World Effectiveness Study in Denmark

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.

Initial Oral Antibiotics for Bone and Joint Infections in Children