Oral-only Antibiotics for Bone and Joint Infections in Children

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.

Timeline

Start

2020-09-15

Primary completion

2024-01-01

Completion

2024-08-05

Publications

• Nielsen AB, Holm M, Lindhard MS, Glenthoj JP, Borch L, Hartling U, Schmidt LS, Rytter MJH, Rasmussen AH, Damkjaer M, Lemvik G, Petersen JJH, Sondergaard MJ, Thaarup J, Kristensen K, Jensen LH, Hansen LH, Lawaetz MC, Gottliebsen M, Horsager TH, Zaharov T, Hoffmann TU, Nygaard T, Justesen US, Stensballe LG, Vissing NH, Blanche P, Schmiegelow K, Nygaard U. Oral versus intravenous empirical antibiotics in children and adolescents with uncomplicated bone and joint infections: a nationwide, randomised, controlled, non-inferiority trial in Denmark. Lancet Child Adolesc Health. 2024 Sep;8(9):625-635. doi: 10.1016/S2352-4642(24)00133-0. Epub 2024 Jul 15.
• Bybeck Nielsen A, Borch L, Damkjaer M, Glenthoj JP, Hartling U, Hoffmann TU, Holm M, Helleskov Rasmussen A, Schmidt LS, Schmiegelow K, Stensballe LG, Nygaard U; Local Investigators. Oral-only antibiotics for bone and joint infections in children: study protocol for a nationwide randomised open-label non-inferiority trial. BMJ Open. 2023 Jun 1;13(6):e072622. doi: 10.1136/bmjopen-2023-072622.

Drugs

Indications