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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04538053
Registration number
NCT04538053
Ethics application status
Date submitted
14/07/2020
Date registered
3/09/2020
Date last updated
9/08/2023
Titles & IDs
Public title
BonE and Joint Infections - Simplifying Treatment in Children Trial
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Scientific title
BonE and Joint Infections - Simplifying Treatment in Children Trial
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Secondary ID [1]
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2019.287
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Universal Trial Number (UTN)
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Trial acronym
BEST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bone Infection
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Septic Arthritis
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Bone and Joint Infection
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Osteomyelitis
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of children assessed as having made a full recovery 3 months
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Assessment method [1]
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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.
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Proportion of children with with recurrent disease at 6 months.
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Assessment method [1]
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Proportion of children with recurrence of symptoms and signs after initial recovery requiring further antibiotic administration assessed at 3 months by an independent committee.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Proportion of children with with recurrent disease at 12 months.
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Assessment method [2]
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Proportion of children with recurrence of symptoms and signs after initial recovery requiring further antibiotic administration assessed at 12 months by an independent committee.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Proportion of children with complications of their disease at 3 months.
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Assessment method [3]
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Complications assessed by an independent committee defined as:
(i) residual dysfunction (ii) pain
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Timepoint [3]
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3 months
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Secondary outcome [4]
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Proportion of children with complications of their disease at 12 months.
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Assessment method [4]
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Complications assessed by an independent committee defined as:
(i) residual poor function (ii) bone death (osteonecrosis) (iii) pain (iv) growth arrest (v) limb deformity
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Proportion of children with treatment-related adverse effects (AEs).
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Assessment method [5]
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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)
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Timepoint [5]
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Between Day 1-7
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Secondary outcome [6]
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Quality of life - Pediatric Quality of Life Inventory (PedsQL) 3 months
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Assessment method [6]
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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).
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Timepoint [6]
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3 months
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Secondary outcome [7]
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Quality of life - Child Health Utility Scale (CHU9D) Day 8-14
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Assessment method [7]
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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.
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Timepoint [7]
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Once between Day 8 to Day 14
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Secondary outcome [8]
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Quality of life - Child Health Utility Scale (CHU9D) 12 months
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Assessment method [8]
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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)
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Timepoint [8]
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12 months
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Secondary outcome [9]
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Quality of life - EQ-5d Day 8-14
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Assessment method [9]
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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.
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Timepoint [9]
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Once between Day 8 to Day 14
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Secondary outcome [10]
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Cost effectiveness - cost-effectiveness ratio of all resources at 12 months
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Assessment method [10]
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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.
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Timepoint [10]
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12 months
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Secondary outcome [11]
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Treatment adherence - medication reconciliation at 3 weeks
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Assessment method [11]
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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
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Timepoint [11]
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Week 3
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Secondary outcome [12]
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Treatment adherence - Medication Adherence Response Scale at 3 weeks
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Assessment method [12]
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Outcome will be reported as median adherence score (range 5-25).
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Timepoint [12]
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Week 3
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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.
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Minimum age
1
Year
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2026
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Actual
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Sample size
Target
285
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sydney Children's Hospital Network - Sydney
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Recruitment hospital [2]
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The Children's Hospital at Westmead - Sydney
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Recruitment hospital [3]
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Royal Darwin Hospital - Darwin
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Recruitment hospital [4]
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Queensland Children's Hospital - Brisbane
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Recruitment hospital [5]
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Women's and Children's Hospital - Adelaide
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Recruitment hospital [6]
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The Royal Children's Hospital - Melbourne
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Recruitment hospital [7]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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2031 - Sydney
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Recruitment postcode(s) [2]
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2145 - Sydney
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Recruitment postcode(s) [3]
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0811 - Darwin
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Recruitment postcode(s) [4]
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4101 - Brisbane
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Recruitment postcode(s) [5]
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5006 - Adelaide
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Recruitment postcode(s) [6]
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3051 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04538053
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Amanda Gwee, PhD
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Address
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Murdoch Childrens Research Institute
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Alison Boast, MD
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Address
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Country
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Phone
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+61393455522
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04538053
Download to PDF