BonE and Joint Infections - Simplifying Treatment in Children Trial

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Sep 1, 2020

Keywords

ClinConnect Summary

The BonE and Joint Infections - Simplifying Treatment in Children Trial is a study looking at how to treat children with bone and joint infections more effectively. It aims to find out if giving children all of their antibiotics by mouth (orally) is just as good as starting with antibiotics through an IV (a needle in the vein) for the first few days, followed by oral antibiotics. The trial involves children aged 1 to 18 years who have simple bone and joint infections and are being treated at eight major children's hospitals in Australia and New Zealand.

To be eligible for this trial, children should have a straightforward infection that is not caused by resistant bacteria, and they should not have serious complications or other health issues that might affect how they respond to treatment. If chosen to participate, children will be randomly assigned to receive either the oral-only treatment or the standard treatment for comparison. This study is currently recruiting participants, and it could help improve how we treat these infections in the future, making recovery easier for children and their families.

Gender

ALL

Eligibility 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