BonE and Joint Infections - Simplifying Treatment in Children Trial (BEST)

  • STATUS
    Recruiting
  • End date
    Dec 18, 2026
  • participants needed
    285
  • sponsor
    Murdoch Childrens Research Institute
Updated on 18 June 2022
antibiotics

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.

Description

Children with acute onset BJIs who present to the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'standard treatment group' will receive standard treatment for BJIs, which consists of IV antibiotics for 1-7 days followed by 3 weeks of oral antibiotics. Children in the 'entirely oral treatment group' will receive high dose oral antibiotics, followed by the standard dose of oral antibiotics for 3 weeks. The outcomes of children in each of the two groups will be compared to determine whether BJIs can be treated without needing a course of IV antibiotics.

Details
Condition Bone Infection, Septic Arthritis, Bone and Joint Infection, Osteomyelitis
Treatment Oral cefalexin only, IV cefazolin followed by oral cefalexin, IV cefazolin or IV flucloxacillin followed by oral cefalexin
Clinical Study IdentifierNCT04538053
SponsorMurdoch Childrens Research Institute
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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; subperiosteal 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
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