Oral-only antibiotics for bone and joint infections in children: Study protocol for a nationwide randomised open-label non-inferiority trial

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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.

OriginalsprogEngelsk
Artikelnummere072622
TidsskriftBMJ Open
Vol/bind13
Udgave nummer6
Antal sider9
ISSN2044-6055
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
Funding is received from The Research Foundation of Copenhagen University Hospital, Copenhagen Health Science Partners and Innovation Fund Denmark. The funding covers salaries for study doctors, statisticians, and additional expenses (eg, software and hardware). The funding is administered through research accounts at the Copenhagen University Hospital Rigshospitalet.

Funding Information:
The project is initiated by chief investigators Allan Bybeck Nielsen and Ulrikka Nygaard (sponsor). Each site has a primary investigator. The protocol is finalised by the listed authors which includes the chief investigators, main collaborators (Professor Lone Graff Stensballe and Professor Kjeld Schmiegelow) as well as primary investigators from sites with an expected inclusion of more than 10 participants. Funding is received from The Research Foundation of Copenhagen University Hospital, Copenhagen Health Science Partners and Innovation Fund Denmark. None of the investigators or main collaborators are financially attached to private enterprises, foundations, etc that have interests in the research project. Neither the patients enrolled in the project, nor their families, will receive any kind of payment for participating in the project.

Publisher Copyright:
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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