Overview

BonE and Joint Infections - Simplifying Treatment in Children Trial

Status:
Recruiting
Trial end date:
2023-09-01
Target enrollment:
0
Participant gender:
All
Summary
This is a single centre trial of children with bone and joint infections (BJIs). 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 2 to 4 days followed by an oral antibiotic course in achieving full recovery 12 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Murdoch Childrens Research Institute
Treatments:
Cefazolin
Cephalexin
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; subperiosteal 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 one 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