BonE and Joint Infections - Simplifying Treatment in Children Trial

2019.287

This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. 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.

2021-06-01

2026-12-01

2026-12-01

Recruiting

Early phase I

285

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 285, 'type': 'ESTIMATED'}}

2023-08-09