BonE and Joint Infections - Simplifying Treatment in Children Trial

Inclusion Criteria:

• Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone andjoint infection who fulfil pre-defined clinical criteria.

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 usingdefinitions 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 toor complicated by trauma)

5. History of allergy to cephalosporin antibiotics or immediate, severe reaction topenicillins

6. Received more than three IV or oral dose of an antibiotic with activity against thelikely 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