Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.

Disqualifiers

Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)

Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score)

Concomitant severe, invasive infection e.g. necrosing fasciitis

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)

Trial design

Treatments tested in this trial

  • Oral cefalexin only
  • IV cefazolin or IV flucloxacillin followed by oral cefalexin

Treatment groups

285 Participants
are divided into 2 treatment groups

Locations

10
Australia
Nepean Hospital2747, KingswoodNew South Wales, Australia
John Hunter Children's Hospital2305, New Lambton HeightsNew South Wales, Australia
Sydney Children's Hospital Network2031, SydneyNew South Wales, Australia
The Children's Hospital at Westmead2145, SydneyNew South Wales, Australia

Sponsors and collaborators

Murdoch Childrens Research Institute

Lead sponsor

Source ClinicalTrials.gov