Oral antibiotics for treating bone and joint infections in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Children aged 1 to 18 years with acute, uncomplicated, uncomplicated, haematogenous osteomyelitis or septic arthritis
2. Symptoms are present for ≤10 days
3. Osteomyelitis (OM): involvement of long bones of arm or leg AND either pain, point tenderness upon palpation of bone or joint, or difficulty weight bearing; OR Septic arthritis (SA): any of painful and/or swollen large joint; restriction of joint movement; tenderness or warmth. Those with both SA and OM at the same site as the current infection are also eligible.
4. The participant has an elevated C-reactive protein (CRP) ≥20 mg/L or erythrocyte sedimentation rate (ESR) ≥10 mm/h

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. necrotising fasciitis
4. Complicated infection (e.g. presence of prosthetic material; large subperiosteal or intraosseous (either \>3 mm) abscess 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 four IV or oral doses of an antibiotic with activity against the likely bacteria causing the current infection
7. Prior episode of osteomyelitis (OM) or septic arthritis (SA) of the same site
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 it's running

• 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
• 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

Study contacts

• Principal investigator: Amanda Gwee, PhD — Murdoch Childrens Research Institute
• Study coordinator: Alison Boast, MD
• Email: alison.boast@gmail.com
• Phone: +61393455522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.