BonE and Joint Infections - Simplifying Treatment in Children Trial

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: - Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint 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 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of children assessed as having made a full recovery 3 months

Secondary Outcome Measures

Name	Time	Method
Proportion of children with with recurrent disease at 6 months.;Proportion of children with with recurrent disease at 12 months.;Proportion of children with complications of their disease at 3 months.;Proportion of children with complications of their disease at 12 months.;Proportion of children with treatment-related adverse effects (AEs).;Quality of life - Pediatric Quality of Life Inventory (PedsQL) 3 months;Quality of life - Child Health Utility Scale (CHU9D) Day 8-14;Quality of life - Child Health Utility Scale (CHU9D) 12 months;Quality of life - EQ-5d Day 8-14;Cost effectiveness - cost-effectiveness ratio of all resources at 12 months;Treatment adherence - medication reconciliation at 3 weeks;Treatment adherence - Medication Adherence Response Scale at 3 weeks