Oral-only Antibiotics for Bone and Joint Infections in Children - A Nationwide Randomized Controlled Trial
Who is this study for? Children with bone and joint infections
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 17
Healthy Volunteers: f
View:
• Children aged 3 months to 18 years with antibiotic treatment of uncomplicated bone or joint infection.
Locations
Other Locations
Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen
Time Frame
Start Date: 2020-09-15
Completion Date: 2024-08-05
Participants
Target number of participants: 180
Treatments
Active_comparator: Experimental
\< 5 years: High-dose oral co-amoxiclav (1:8) 33 mg amoxicillin/kg/dose (max. 1 g) three-times daily (TDS) until clinical and paraclinical improvement (min. 3 days) followed by oral co-amoxiclav (1:4) 17 mg amoxicillin/kg/dose (max. 500 mg) TDS for 7 days (arthritis) or 21 days (osteomyelitis).~=/\> 5 years: High-dose oral dicloxacillin 50 mg/kg/dose (max. 2 g) four-times daily (QID) until clinical and paraclinical improvement (min. 3 days) followed by oral dicloxacillin 25 mg/kg/dose (max. 1 g) QID for 7 days (arthritis) or 21 days (osteomyelitis).~Treatment will be adjusted according to microbiological findings.
Active_comparator: Standard
IV ceftriaxon 100 mg/kg/dose (max. 4 g) once daily (QD) (all ages) until clinical and paraclinical improvement (min. 3 days) followed by:~\< 5 years: Oral co-amoxiclav (1:4) 17 mg amoxicillin/kg/dose (max. 500 mg) TDS for 7 days (arthritis) or 21 days (osteomyelitis).~\>/= 5 years: Oral dicloxacillin 25 mg/kg/dose (max. 1 g) QID for 7 days (arthritis) or 21 days (osteomyelitis).~Treatment will be adjusted according to microbiological findings.
Related Therapeutic Areas
Sponsors
Collaborators: The research foundation of Copenhagen University Hospital, Rigshospitalet, Copenhagen Health Science Partners, Innovation Fund Denmark
Leads: Rigshospitalet, Denmark