BonE and Joint Infections - Simplifying Treatment in Children Trial

This is a multi- centre trial of children with bone and joint infections (BJIs) at eleven major paediatric hospitals in Australia, New Zealand and Ireland. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.

Inclusion Criteria: 1. Children aged 1 to 18 years with acute, uncomplicated, uncomplicated, haematogenous osteomyelitis or septic arthritis 2. Symptoms are present for ≤10 days 3. Osteomyelitis (OM): involvement of long bones of arm or leg AND either pain, point tenderness upon palpation of bone or joint, or difficulty weight bearing; OR Septic arthritis (SA): any of painful and/or swollen large joint; restriction of joint movement; tenderness or warmth. Those with both SA and OM at the same site as the current infection are also eligible. 4. The participant has an elevated C-reactive protein (CRP) ≥20 mg/L or erythrocyte sedimentation rate (ESR) ≥10 mm/h Exclusion Criteria: 1. Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal) 2. Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score) 3. Concomitant severe, invasive infection e.g. necrotising fasciitis 4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal or intraosseous (either \>3 mm) abscess or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma) 5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins 6. Received more than four IV or oral doses of an antibiotic with activity against the likely bacteria causing the current infection 7. Prior episode of osteomyelitis (OM) or septic arthritis (SA) of the same site 8. Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency) 9. Prior enrolment in the trial 10. Current recipient of another investigational product as part of a clinical trial