Actively Recruiting

Phase 4
Age: 1Year - 18Years
All Genders
NCT04538053

BonE and Joint Infections - Simplifying Treatment in Children Trial

Led by Murdoch Childrens Research Institute · Updated on 2025-11-17

285

Participants Needed

10

Research Sites

287 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

BonE and Joint Infections - Simplifying Treatment in Children Trial

Who Can Participate

Age: 1Year - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.
Not Eligible

You will not qualify if you...

  • Infection caused by bacteria resistant to cefalexin or by atypical infections such as mycobacterial or fungal infections
  • Signs of sepsis defined by organ dysfunction according to the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score
  • Presence of a severe, invasive infection like necrosing fasciitis
  • Complicated infection including prosthetic material, large subperiosteal (>3mm) or soft tissue abscess without surgery, or infection linked to trauma
  • History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
  • Received more than three doses of intravenous or oral antibiotics active against the likely bacteria causing the current infection
  • Previous episode of osteomyelitis or septic arthritis
  • Existing conditions causing poor absorption (e.g., inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease such as immunodeficiency
  • Prior participation in this trial
  • Currently receiving another investigational product as part of a clinical trial

AI-Screening

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Trial Site Locations

Total: 10 locations

1

Nepean Hospital

Kingswood, New South Wales, Australia, 2747

Actively Recruiting

2

John Hunter Children's Hospital

New Lambton Heights, New South Wales, Australia, 2305

Actively Recruiting

3

Sydney Children's Hospital Network

Sydney, New South Wales, Australia, 2031

Actively Recruiting

4

The Children's Hospital at Westmead

Sydney, New South Wales, Australia, 2145

Active, Not Recruiting

5

Royal Darwin Hospital

Darwin, Northern Territory, Australia, 0811

Actively Recruiting

6

Queensland Children's Hospital

Brisbane, Queensland, Australia, 4101

Actively Recruiting

7

Women's and Children's Hospital

Adelaide, South Australia, Australia, 5006

Actively Recruiting

8

The Royal Children's Hospital

Melbourne, Victoria, Australia, 3051

Actively Recruiting

9

Perth Children's Hospital

Perth, Western Australia, Australia, 6009

Actively Recruiting

10

Christchurch Hospital

Christchurch, New Zealand, 8011

Actively Recruiting

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Research Team

A

Alison Boast, MD

CONTACT

A

Amanda Gwee, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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