BonE and Joint Infections - Simplifying Treatment in Children Trial

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. necrosing fasciitis
• •4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal (\>3mm) 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 three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection
• •7. Prior episode of OM or SA
• •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