An observational study in Osteomyelitis Acute, Septic Arthritis and Bone Infection, sponsored by Rigshospitalet, Denmark. Recruiting at 1 site in Denmark. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Rigshospitalet, Denmark · Observational
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.
Background:
Initial oral antibiotic treatment for children and adolescents with uncomplicated BJI has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT) from Denmark. The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear. In Denmark, initial oral antibiotics were allowed in nationwide guidelines for children and adolescents aged 3 months to 17 years with uncomplicated BJI from 2024.
Aim:
We aim to compare the effectiveness and safety of initial oral antibiotics for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.
Study design:
Nationwide, prospective, multicenter, real-world cohort study.
Patients:
100 children and adolescents aged 3 months to 17 years with uncomplicated BJI treated with initial oral antibiotics at one of the 18 Pediatric Departments in Denmark from 2024 to 2026. Uncomplicated BJI is defined by the absence of impaired general condition or signs of sepsis, rapidly progressing or severe symptoms, pronounced soft tissue involvement, prosthetic material, resistant pathogens, and severe comorbidities. Patients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included.
Control patients are 98 patients who received initial oral antibiotics for uncomplicated BJI as part of a Danish RCT conducted between 2020 and 2023.
Methods:
All children and adolescents treated for BJI will be prospectively enrolled. Designated co-investigators in the 18 Danish pediatric departments will ensure prospective, national inclusion. Follow-up assessments will be conducted after three, six, 12 month. The three-month follow-up will include a clinical examination to ensure full recovery. The six and 12-month follow-up will be conducted via a structured telephone interview and/or a clinical evaluation.
All study data will be securely collected and managed in an online database.
Outcomes:
The primary outcome is sequelae after 6 months, defined as any atypical mobility or function of the affected bone or joint.
Secondary outcomes are suspicion of treatment failure within 28 days, full recovery after initiation of treatment, recurrent infection within 6 months, and sequelae after 12 months and 5 years.
Safety outcomes are surgical intervention and severe complications during antibiotic treatment.
We will calculate the risk difference sequelae between the real-world and RCT cohorts using exact unconditional two-sided 95% confidence interval.
51 studies on the registry are indexed under Arthritis, Infectious; 12 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 30 observational studies indexed under Arthritis, Infectious.
Browse Arthritis, Infectious studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children aged 3 months to 17 years with uncomplicated bone and joint infections treated with initial oral antibioticsbetween 15th of November 2024 and 15th of November 2026
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:
Patients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included
Patients 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
Drug: Oral antibiotic treatment
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
Clinical sequelae at 6 months
Clinical sequelae is defined as any abnormal mobility or function of the affected bone or joint. Clinical sequelae will be evaluated through a structured medical telephone interview at 6 months with a parent or a guardian (or the patient, if adolescent, along with the parent). If the medical interview raises any concerns about abnormal mobility or function of the affected bone or joint, or if the patient is scheduled for a clinical consultation, clinical sequelae will be evaluated by a clinical examination performed by a pediatrician or an orthopedic surgeon.
Time frame: 6 months after end of treatment [4-9 months]
Suspicion of treatment failure within 28 days
Change of antibiotic therapy due to suspicion of treatment treatment failure or slow recovery, such as persistent fever for more than 3 days, iincrease in C-reactive protein after 4 days, or absence of clinical improvement within 5 days of treatment initiation.
Time frame: 28 days after initiation of treatment
Full recovery after initiation of treatment
Full recovery is defined as absence of clinical features of the affected bone or joint. Assessment made by a pediatrician or orthopedic surgeon.
Time frame: Within 3 months after initiation of treatment (0-4 months)
Recurrent infection within 6 months
Recurrence of symptoms and signs requiring readministration of antibiotics after initial recovery and cessation of antibiotic treatment.
Time frame: 6 months after the end of treatment
Clinical sequelae at 12 months
Clinical sequelae is defined as any abnormal mobility or function of the affected bone or joint. Clinical sequelae will be evaluated through a structured medical telephone interview at 12 months with a parent or a guardian (or the patient, if adolescent, along with the parent). If the medical interview raises any concerns about abnormal mobility or function of the affected bone or joint, or if the patient is scheduled for a clinical consultation, clinical sequelae will be evaluated by a clinical examination performed by a pediatrician or an orthopedic surgeon.
Time frame: 12 months after the end of treatment [9-16 months]
Sequelae at 5 years
Sequelae is defined as any abnormal mobility or function of the affected bone or joint. The child is deemed to have no long-term clinical sequelae if there are no hospital contacts for atypical mobility or function of the affected bone or joint and if he/she is still registered as residing in Denmark (defined as 'lost to follow-up' if no longer residing in Denmark)
Time frame: 5 years after the end of treatment [4-6 years]
Safety outcome 1: Surgical intervention
Surgical intervention during antibiotic treatment excluding diagnostic interventions, such as diagnostic bone biopsy or diagnostic joint aspiration with or without lavage.
Time frame: 28 days after initiation of treatment
Safety outcome 2: Severe complications during antibiotic treatment
Severe complications during antibiotic treatment, e.g. need for intensive care, septic shock, organ failure, pyomyositis, endocarditis, deep venous thrombosis.
Time frame: 28 days after initiation of treatment
Plan to share: Undecided
Started Nov 2024 (actual). Primary completion is estimated for Nov 2026, 24 months after the start.
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