Menu
Recruiting NCT04538053

BonE and Joint Infections - Simplifying Treatment in Children Trial

Phase IV Interventional Bone Infection Septic Arthritis Bone and Joint Infection Osteomyelitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral cefalexin only, IV cefazolin or IV flucloxacillin followed by oral cefalexin.
Who it may be relevant to
Registry conditions: Bone Infection, Septic Arthritis, Bone and Joint Infection, Osteomyelitis. Basic parameters: 1 year — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

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

Primary outcome measures

  • Proportion of children assessed as having made a full recovery 3 months [Time frame: 3 months]
Secondary outcome measures (12)
  • Proportion of children with with recurrent disease at 6 months. [Time frame: 6 months]
  • Proportion of children with with recurrent disease at 12 months. [Time frame: 12 months]
  • Proportion of children with complications of their disease at 3 months. [Time frame: 3 months]
  • Proportion of children with complications of their disease at 12 months. [Time frame: 12 months]
  • Proportion of children with treatment-related adverse effects (AEs). [Time frame: Between Day 1-7]
  • Quality of life - Pediatric Quality of Life Inventory (PedsQL) 3 months [Time frame: 3 months]
  • Quality of life - Child Health Utility Scale (CHU9D) Day 8-14 [Time frame: Once between Day 8 to Day 14]
  • Quality of life - Child Health Utility Scale (CHU9D) 12 months [Time frame: 12 months]
  • Quality of life - EQ-5d Day 8-14 [Time frame: Once between Day 8 to Day 14]
  • Cost effectiveness - cost-effectiveness ratio of all resources at 12 months [Time frame: 12 months]
  • Treatment adherence - medication reconciliation at 3 weeks [Time frame: Week 3]
  • Treatment adherence - Medication Adherence Response Scale at 3 weeks [Time frame: Week 3]

Eligibility criteria

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; 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 9 centers
  • Nepean Hospital — Kingswood
  • John Hunter Children's Hospital — New Lambton Heights
  • Sydney Children's Hospital Network — Sydney
  • The Children's Hospital at Westmead — Sydney
  • Royal Darwin Hospital — Darwin
  • Queensland Children's Hospital — Brisbane
  • Women's and Children's Hospital — Adelaide
  • The Royal Children's Hospital — Melbourne
  • … and 1 more center
New Zealand · 1 center
  • Christchurch Hospital — Christchurch

Identifiers

NCT: NCT04538053 · 2019.287

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗