Overview

Oral-only Antibiotics for Bone and Joint Infections in Children

Status:
Recruiting
Trial end date:
2024-09-15
Target enrollment:
0
Participant gender:
All
Summary
A nationwide, multicenter, randomized, non-inferiority trial of children with bone and joint infections. The primary objective is to determine if oral-only antibiotics (experimental arm) is non-inferior to initial intravenous antibiotics followed by oral therapy (control arm). Children will be randomized 1:1. The total treatment duration is identical in both groups. The study is open label with blinding of the primary endpoint assessor.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rigshospitalet, Denmark
Collaborators:
Copenhagen Health Science Partners
Innovation Fund Denmark
The research foundation of Copenhagen University Hospital, Rigshospitalet
Treatments:
Amoxicillin-Potassium Clavulanate Combination
Ceftriaxone
Dicloxacillin
Criteria
Inclusion Criteria:

- Children aged 3 months to 18 years with antibiotic treatment of uncomplicated bone or
joint infection.

Exclusion Criteria:

1. Severe disease, e.g. septic shock, or any concomitant infection, e.g. necrotizing
fasciitis, requiring IV antibiotics in the opinion of the treating clinician.

2. Complicated bone or joint infection, e.g. prosthetic material, infection secondary to
or complicated by trauma, severe pyomyositis or other substantial soft tissue
infections.

3. Expected need of major surgery within the first 24 hours of treatment, e.g. drilling,
debridement, fenestration, surgical drainage, synovectomy. Minor surgery as diagnostic
surgical bone biopsy or diagnostic joint fluid aspiration including lavage is not a
criterion for exclusion.

4. Significant co-morbidities that might influence the choice of treatment or the course
of the infection, e.g. immunodeficiency, immunosuppressive therapy, sickle cell
anemia.

5. Previous bone or joint infection.

6. Antibiotic therapy for more than 24 hours before inclusion.

7. Documented pathogen with limited treatment options that do not permit randomization,
e.g. the pathogen is only sensitive to intravenous antibiotics.

8. Prior enrolment in the trial