Oral-only Antibiotics for Bone and Joint Infections in Children (CHILD@HOME_BJI)

  • STATUS
    Recruiting
  • End date
    Sep 15, 2024
  • participants needed
    180
  • sponsor
    Rigshospitalet, Denmark
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Updated on 4 October 2022
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antibiotics

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.

Details
Condition Osteomyelitis, Septic Arthritis, Bone Infection, Joint Infection, Bone and Joint Infection
Treatment Oral co-amoxiclav or oral dicloxacillin only, IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin
Clinical Study IdentifierNCT04563325
SponsorRigshospitalet, Denmark
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Severe disease, e.g. septic shock, or any concomitant infection, e.g. necrotizing fasciitis, requiring IV antibiotics in the opinion of the treating clinician
Complicated bone or joint infection, e.g. prosthetic material, infection secondary to or complicated by trauma, severe pyomyositis or other substantial soft tissue infections
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
Significant co-morbidities that might influence the choice of treatment or the course of the infection, e.g. immunodeficiency, immunosuppressive therapy, sickle cell anemia
Previous bone or joint infection
Antibiotic therapy for more than 24 hours before inclusion
Documented pathogen with limited treatment options that do not permit randomization, e.g. the pathogen is only sensitive to intravenous antibiotics
Prior enrolment in the trial
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