Initial Oral Antibiotics for 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
Rigshospitalet, Denmark
100 participants
Nov 15, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria10
- 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:
- Severe illness or sepsis
- Rapid symptom progression
- Pronounced symptoms, including severe pain
- Pronounced soft tissue involvement
- Foreign material or post-surgical infection
- Infection with a resistent or rare pathogen, e.g., Salmonella or MRSA
- 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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Interventions
Initial antibiotics: Below 5 years: High-dose amoxicillin-clavulanate (8:1 ratio; 100/12.5 mg/kg/day in 3 doses) until clinical improvement and decrease in CRP, followed by dose reduction (4:1 ratio) to 50/12.5 mg/kg/day in 3 doses). 5 years and above: High-dose anti-staphylococcal penicillin (200 mg/kg/day in 4 doses) until clinical improvement and decrease in CRP, with dose reduction (100 mg/kg/day in 4 doses) after clinical improvement Treatment duration of follow-up therapy (after initial high-dose antibiotics): One week for uncomplicated joint infections, three weeks for bone infections, and four weeks for spondylodiscitis
Locations(1)
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NCT06827496