NCT04563325

Oral-only Antibiotics for Bone and Joint Infections in Children

Oral-only Antibiotics for Bone and Joint Infections in Children - A Nationwide Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 3 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteomyelitis
• Septic Arthritis
• Bone Infection
• Joint Infection
• Bone and Joint Infection

Interventions

Type	Name	Description
DRUG	Oral co-amoxiclav or oral dicloxacillin only	High dose oral treatment followed by standard dose oral treatment
DRUG	IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin	IV treatment followed by standard dose oral treatment

Timeline

• Start date: 2020-09-15
• Primary completion: 2024-01-01
• Completion: 2024-08-05
• First posted: 2020-09-24
• Last updated: 2025-04-13

Locations

1 site across 1 country: Denmark