Oral antibiotics for treating bone and joint infections in children

BonE and Joint Infections - Simplifying Treatment in Children Trial

This study tests if giving only oral antibiotics can effectively treat bone and joint infections in children, compared to the usual method that starts with IV antibiotics.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 285 (estimated)
• Ages: 1 Year to 18 Years
• Sex: All
• Sponsor: Murdoch Childrens Research Institute (Academic / other)
• Locations: 10 sites (Kingswood, New South Wales and 9 other locations)
• Trial ID: NCT04538053 on ClinicalTrials.gov

What this trial studies

This trial involves children with acute, uncomplicated bone and joint infections at eight major pediatric hospitals in Australia and New Zealand. The study aims to determine if entirely oral antibiotic treatment is as effective as the standard treatment, which includes initial intravenous antibiotics followed by oral antibiotics. Participants will be randomly assigned to either the entirely oral treatment group or the standard treatment group, and their recovery will be assessed three months after presentation. The goal is to simplify treatment protocols for these infections in children.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infections.

Not a fit: Patients with infections due to resistant bacteria, complicated infections, or severe allergic reactions to cephalosporins may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to less invasive treatment options for children with bone and joint infections, reducing the need for intravenous antibiotics.

How similar studies have performed: Previous studies have shown that oral antibiotics can be effective for certain infections, suggesting potential success for this approach, though this specific comparison is novel.

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

Where this trial is running

Kingswood, New South Wales and 9 other locations

• Nepean Hospital — Kingswood, New South Wales, Australia (Recruiting)
• John Hunter Children's Hospital — New Lambton Heights, New South Wales, Australia (Recruiting)
• Sydney Children's Hospital Network — Sydney, New South Wales, Australia (Recruiting)
• The Children's Hospital at Westmead — Sydney, New South Wales, Australia (Active_not_recruiting)
• Royal Darwin Hospital — Darwin, Northern Territory, Australia (Recruiting)
• Queensland Children's Hospital — Brisbane, Queensland, Australia (Recruiting)
• Women's and Children's Hospital — Adelaide, South Australia, Australia (Recruiting)
• The Royal Children's Hospital — Melbourne, Victoria, Australia (Recruiting)
• Perth Children's Hospital — Perth, Western Australia, Australia (Recruiting)
• Christchurch Hospital — Christchurch, New Zealand (Recruiting)

Study contacts

• Principal investigator: Amanda Gwee, PhD — Murdoch Childrens Research Institute
• Study coordinator: Alison Boast, MD

Conditions Bone Infection; Septic Arthritis; Bone and Joint Infection; Osteomyelitis