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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04538053




Registration number
NCT04538053
Ethics application status
Date submitted
14/07/2020
Date registered
3/09/2020
Date last updated
8/11/2024

Titles & IDs
Public title
BonE and Joint Infections - Simplifying Treatment in Children Trial
Scientific title
BonE and Joint Infections - Simplifying Treatment in Children Trial
Secondary ID [1] 0 0
2019.287
Universal Trial Number (UTN)
Trial acronym
BEST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Infection 0 0
Septic Arthritis 0 0
Bone and Joint Infection 0 0
Osteomyelitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral cefalexin only
Treatment: Drugs - IV cefazolin or IV flucloxacillin followed by oral cefalexin

Active comparator: Intervention - 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

Active comparator: Standard Therapy - 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


Treatment: Drugs: Oral cefalexin only
High-dose oral cefalexin

Treatment: Drugs: IV cefazolin or IV flucloxacillin followed by oral cefalexin
Standard therapy of IV cefazolin or IV flucloxacillin followed by high dose oral cefalexin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of children assessed as having made a full recovery 3 months
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Proportion of children with with recurrent disease at 6 months.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Proportion of children with with recurrent disease at 12 months.
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Proportion of children with complications of their disease at 3 months.
Timepoint [3] 0 0
3 months
Secondary outcome [4] 0 0
Proportion of children with complications of their disease at 12 months.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Proportion of children with treatment-related adverse effects (AEs).
Timepoint [5] 0 0
Between Day 1-7
Secondary outcome [6] 0 0
Quality of life - Pediatric Quality of Life Inventory (PedsQL) 3 months
Timepoint [6] 0 0
3 months
Secondary outcome [7] 0 0
Quality of life - Child Health Utility Scale (CHU9D) Day 8-14
Timepoint [7] 0 0
Once between Day 8 to Day 14
Secondary outcome [8] 0 0
Quality of life - Child Health Utility Scale (CHU9D) 12 months
Timepoint [8] 0 0
12 months
Secondary outcome [9] 0 0
Quality of life - EQ-5d Day 8-14
Timepoint [9] 0 0
Once between Day 8 to Day 14
Secondary outcome [10] 0 0
Cost effectiveness - cost-effectiveness ratio of all resources at 12 months
Timepoint [10] 0 0
12 months
Secondary outcome [11] 0 0
Treatment adherence - medication reconciliation at 3 weeks
Timepoint [11] 0 0
Week 3
Secondary outcome [12] 0 0
Treatment adherence - Medication Adherence Response Scale at 3 weeks
Timepoint [12] 0 0
Week 3

Eligibility
Key inclusion criteria
* Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.
Minimum age
1 Year
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)
2. Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score)
3. Concomitant severe, invasive infection e.g. necrosing fasciitis
4. 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)
5. History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
6. Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection
7. Prior episode of OM or SA
8. Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency)
9. Prior enrolment in the trial
10. Current recipient of another investigational product as part of a clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
285
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
John Hunter Children's Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Sydney Children's Hospital Network - Sydney
Recruitment hospital [4] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment hospital [5] 0 0
Royal Darwin Hospital - Darwin
Recruitment hospital [6] 0 0
Queensland Children's Hospital - Brisbane
Recruitment hospital [7] 0 0
Women's and Children's Hospital - Adelaide
Recruitment hospital [8] 0 0
The Royal Children's Hospital - Melbourne
Recruitment hospital [9] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2031 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Sydney
Recruitment postcode(s) [5] 0 0
0811 - Darwin
Recruitment postcode(s) [6] 0 0
4101 - Brisbane
Recruitment postcode(s) [7] 0 0
5006 - Adelaide
Recruitment postcode(s) [8] 0 0
3051 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04538053
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Gwee, PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alison Boast, MD
Address 0 0
Country 0 0
Phone 0 0
+61393455522
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04538053