BonE and Joint Infections - Simplifying Treatment in Children Trial

NCT04538053 | Recruiting Phase 4 DMC

• 1 other identifier: 2019.287
• Study Type: interventional
• Target: 285
• Locations: 2 countries
• Sites: 10

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of children assessed as having made a full recovery 3 months

  Full recovery is defined by the absence of: (i) Clinical features of osteomyelitis or septic arthritis (ii) No episodes of disease recurrence requiring further antibiotic administration after initial treatment. Assessment made by a qualified paediatrician.

  3 months

Secondary Outcomes (12)

• Proportion of children with with recurrent disease at 6 months.

  6 months

• Proportion of children with with recurrent disease at 12 months.

  12 months

• Proportion of children with complications of their disease at 3 months.

  3 months

• Proportion of children with complications of their disease at 12 months.

  12 months

• Proportion of children with treatment-related adverse effects (AEs).

  Between Day 1-7

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Children will receive high-dose oral cefalexin 37.5 mg/kg/dose (max 1.5 g) QID 1 to 7 days followed by oral cefalexin 45 mg/kg/dose (max 1.5 g) TDS for a total course of 3 weeks

Drug: Oral cefalexin only

Standard Therapy

ACTIVE COMPARATOR

Children will receive IV cefazolin 50 mg/kg/dose (max 2 g) three-times daily (TDS) or IV flucloxacillin 50 mg/kg/dise (max 2 g) four-times daily (QID) for 1 to 7 days followed by oral cefalexin 45 mg/kg/dose (max 1.5 g) three-times daily (TDS) for a total course of 3 weeks

Drug: IV cefazolin or IV flucloxacillin followed by oral cefalexin

Interventions

Oral cefalexin only DRUG

High-dose oral cefalexin

Intervention

IV cefazolin or IV flucloxacillin followed by oral cefalexin DRUG

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

Standard Therapy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)
• History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
• Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection
• Prior episode of OM or SA
• Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency)
• Prior enrolment in the trial
• Current recipient of another investigational product as part of a clinical trial

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (10)

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

RECRUITING

John Hunter Children's Hospital

New Lambton Heights, New South Wales, 2305, Australia

RECRUITING

Sydney Children's Hospital Network

Sydney, New South Wales, 2031, Australia

RECRUITING

The Children's Hospital at Westmead

Sydney, New South Wales, 2145, Australia

ACTIVE NOT RECRUITING

Royal Darwin Hospital

Darwin, Northern Territory, 0811, Australia

RECRUITING

Queensland Children's Hospital

Brisbane, Queensland, 4101, Australia

RECRUITING

Women's and Children's Hospital

Adelaide, South Australia, 5006, Australia

RECRUITING

The Royal Children's Hospital

Melbourne, Victoria, 3051, Australia

RECRUITING

Perth Children's Hospital

Perth, Western Australia, 6009, Australia

RECRUITING

Christchurch Hospital

Christchurch, 8011, New Zealand

RECRUITING

MeSH Terms

Conditions

Arthritis, Infectious; Osteomyelitis

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Bone Diseases, Infectious; Bone Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Amanda Gwee, PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison Boast, MD

CONTACT

+61393455522; alison.boast@gmail.com

Amanda Gwee, PhD

CONTACT

+61393455522; amanda.gwee@rch.org.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: September 3, 2020
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Time Frame: 6 months after publication of primary outcome
• Access Criteria: Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the BEST Trial Principle and Associate Investigators must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Data will only be shared with a recognised research institution which has approved the proposed analysis plan.

Locations

NZ (1); AU (9)