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BonE and Joint Infections - Simplifying Treatment in Children Trial

NCT04538053 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2025-11-17

No results posted yet for this study

Summary

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

  • Bone Infection
  • Septic Arthritis
  • Bone and Joint Infection
  • Osteomyelitis

Interventions

DRUG

Oral cefalexin only

High-dose oral cefalexin

DRUG

IV cefazolin or IV flucloxacillin followed by oral cefalexin

Standard therapy of IV cefazolin or IV flucloxacillin followed by high dose oral cefalexin

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Amanda Gwee, PhD · Murdoch Childrens Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04538053 on ClinicalTrials.gov