Share
Save
BonE and Joint Infections - Simplifying Treatment in Children Trial
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 1 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2021-06-01
Primary completion: 2026-12-01
Study completion finish: 2026-12-01
Study type
TREATMENT
Phase
PHASE4
Trial ID
NCT04538053
Intervention or treatment
DRUG: Oral cefalexin only
DRUG: IV cefazolin or IV flucloxacillin followed by oral cefalexin
Conditions
- • Bone Infection
- • Septic Arthritis
- • Bone and Joint Infection
- • Osteomyelitis
Find a site
Closest Location:
Nepean Hospital
Research sites nearby
Select from list below to view details:
Nepean Hospital
Kingswood, New South Wales, Australia
John Hunter Children's Hospital
New Lambton Heights, New South Wales, Australia
The Children's Hospital at Westmead
Sydney, New South Wales, Australia
Queensland Children's Hospital
Brisbane, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Intervention
| DRUG: Oral cefalexin only
|
ACTIVE_COMPARATOR: Standard Therapy
| DRUG: IV cefazolin or IV flucloxacillin followed by oral cefalexin
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Proportion of children with with recurrent disease at 6 months. | Proportion of children with recurrence of symptoms and signs after initial recovery requiring further antibiotic administration assessed at 3 months by an independent committee. | 6 months |
| Proportion of children with with recurrent disease at 12 months. | Proportion of children with recurrence of symptoms and signs after initial recovery requiring further antibiotic administration assessed at 12 months by an independent committee. | 12 months |
| Proportion of children with complications of their disease at 3 months. | Complications assessed by an independent committee defined as: (i) residual dysfunction (ii) pain | 3 months |
| Proportion of children with complications of their disease at 12 months. | Complications assessed by an independent committee defined as: (i) residual poor function (ii) bone death (osteonecrosis) (iii) pain (iv) growth arrest (v) limb deformity | 12 months |
| Proportion of children with treatment-related adverse effects (AEs). | Adverse effects assessed between days 1-7 including: (i) Complications of IV access (eg need for replacement, infection, extravasation, drug side effects); or (ii) high-dose oral antibiotics (eg. drug side effects, inability to tolerate the full dose) It will be assessed between day 1-7 (can be at any time during the admission while intravenous antibiotics are prescribed) | Between Day 1-7 |
| Quality of life - Pediatric Quality of Life Inventory (PedsQL) 3 months | PedsQL is an acronym for the Pediatric Quality of Life Inventory. This inventory includes 23 items each scored 0 to 5 . The minimum score is 0 and the maximum score is 92. Lower scores indicate better quality of life. Outcome measures will be reported as median (range). | 3 months |
| Quality of life - Child Health Utility Scale (CHU9D) Day 8-14 | CHU9D is an acronym for the Child Health Utility scale. It includes 9 domains scored 0 to 5. The minimum score is 0 and the maximum is 5. The minimum score is 0 and the maximum is 45. Lower scores indicate better quality of life. Outcome measures will be reported as median (range). It will be administered once, and completed any day between Day 8 to Day 14. | Once between Day 8 to Day 14 |
| Quality of life - Child Health Utility Scale (CHU9D) 12 months | CHU9D is an acronym for the Child Health Utility scale. It includes 9 domains scored 0 to 5. The minimum score is 0 and the maximum is 5. The minimum score is 0 and the maximum is 45. Lower scores indicate better quality of life. Outcome measures will be reported as median (range) | 12 months |
| Quality of life - EQ-5d Day 8-14 | EQ-5D is an acronym for the European Quality of Life Five Dimension, it is an instrument which evaluates the generic quality of life. It is a descriptive system with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Outcome measures will be reported as median (range). It will be administered once, and completed any day between Day 8 to Day 14. | Once between Day 8 to Day 14 |
| Cost effectiveness - cost-effectiveness ratio of all resources at 12 months | The incremental cost-effectiveness ratio will be determined for both arms of the trial. This is a summary measure representing the economic value of the intervention (oral cefalexin), compared with the alternative (IV cefazolin followed by oral cefalexin). Estimated total sum of all hospital and patient/family resources required per patient per treatment course (AUD) collected by the study team at each study visit using a standard questionnaire (e.g. clinical services, medication, hospital and family accommodation, travelling, loss of income, care arrangements for family members). The mean total cost per treatment cost (AUD) will be reported for each arm of the trial. | 12 months |
| Treatment adherence - medication reconciliation at 3 weeks | Mean percentage of cefalexin doses taken determined by medication reconciliation (ie. return of any remaining cefalexin) at end of treatment (3 weeks) assessed by the study team/trial pharmacist | Week 3 |
| Treatment adherence - Medication Adherence Response Scale at 3 weeks | Outcome will be reported as median adherence score (range 5-25). | Week 3 |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!