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Recruiting NCT06827496

Initial Oral Antibiotics for Bone and Joint Infections in Children

Trial Parameters

Condition Osteomyelitis Acute
Sponsor Rigshospitalet, Denmark
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 3 Months
Max Age 17 Years
Start Date 2024-11-15
Completion 2026-11-15
Interventions
Oral antibiotic treatment

Brief Summary

Initial oral antibiotic treatment for children and adolescents with uncomplicated bone and joint infections (BJI) has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT). The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear. This nationwide, prospective, multicenter, real-world cohort study aims to compare the effectiveness and safety of initial oral antibiotic treatment for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.

Eligibility 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

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