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Oral-only antibiotics for bone and joint infections in children: study protocol for a nationwide randomised open-label non-inferiority trial.
Bybeck Nielsen, Allan; Borch, Luise; Damkjaer, Mads; Glenthøj, Jonathan Peter; Hartling, Ulla; Hoffmann, Thomas Ulrik; Holm, Mette; Helleskov Rasmussen, Annett; Schmidt, Lisbeth Samsø; Schmiegelow, Kjeld; Stensballe, Lone Graff; Nygaard, Ulrikka.
Afiliación
  • Bybeck Nielsen A; Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Kobenhavn, Denmark allan.bybeck.nielsen@regionh.dk.
  • Borch L; Department of Paediatrics and Adolescent Medicine, Gødstrup Hospital, Herning, Denmark.
  • Damkjaer M; NIDO - Centre for Research and Education, Gødstrup Hospital, Herning, Denmark.
  • Glenthøj JP; Department of Paediatrics and Adolescent Medicine, Lillebaelt Hospital - University Hospital of Southern Denmark, Kolding, Denmark.
  • Hartling U; Regional Health Research, University of Southern Denmark, Odense, Denmark.
  • Hoffmann TU; Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Hillerød, Denmark.
  • Holm M; Department of Paediatrics and Adolescent Medicine, Odense University Hospital, Odense, Denmark.
  • Helleskov Rasmussen A; Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Hvidovre, Denmark.
  • Schmidt LS; Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital, Aarhus, Denmark.
  • Schmiegelow K; Department of Paediatrics and Adolescent Medicine, Lillebaelt Hospital - University Hospital of Southern Denmark, Kolding, Denmark.
  • Stensballe LG; Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Herlev, Denmark.
  • Nygaard U; Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Kobenhavn, Denmark.
BMJ Open ; 13(6): e072622, 2023 06 01.
Article en En | MEDLINE | ID: mdl-37263683
INTRODUCTION: Children with bone and joint infections are traditionally treated with intravenous antibiotics for 3-10 days, followed by oral antibiotics. Oral-only treatment has not been tested in randomised trials. METHODS AND ANALYSIS: Children (3 months to 18 years) will be randomised 1:1 with the experimental group receiving high-dose oral antibiotics and the control group receiving intravenous antibiotics with a shift in both groups to standard oral antibiotics after clinical and paraclinical improvement. Children in need of acute surgery or systemic features requiring intravenous therapy, including septic shock, are excluded. The primary outcome is defined as a normal blinded standardised clinical assessment 6 months after end of treatment. Secondary outcomes are non-acute treatment failure and recurrent infection. Outcomes will be compared by a non-inferiority assumption with an inferiority margin of 5%. ETHICS AND DISSEMINATION: The trial has the potential to reduce unnecessary hospitalisation and use of intravenous antibiotics in children with bone or joint infections. Due to the close follow-up, exclusion of severely ill children and predefined criteria for discontinuation of the allocated therapy, we expect the risk of treatment failure to be minimal. TRIAL REGISTRATION NUMBER: NCT04563325.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Tipo de estudio: Clinical_trials Aspecto: Ethics Límite: Child / Humans Idioma: En Revista: BMJ Open Año: 2023 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Tipo de estudio: Clinical_trials Aspecto: Ethics Límite: Child / Humans Idioma: En Revista: BMJ Open Año: 2023 Tipo del documento: Article País de afiliación: Dinamarca Pais de publicación: Reino Unido