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Trial registered on ANZCTR
Registration number
ACTRN12625000856415
Ethics application status
Approved
Date submitted
13/07/2025
Date registered
7/08/2025
Date last updated
7/08/2025
Date data sharing statement initially provided
7/08/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Safety and efficacy of intravesical gentamicin for recurrent urinary tract infections and/ or catheter blockages
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Scientific title
Safety and efficacy of intravesical gentamicin for recurrent urinary tract infections and/ or catheter blockages in adult patients with any form of bladder drainage
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Secondary ID [1]
314894
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urinary tract infection
338190
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Condition category
Condition code
Infection
334469
334469
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Patient- or carer-administered 30mL of 0.48mg/mL gentamicin solution, intravesical, with solution retention in bladder for 60mins, once in the evening, for six months, as prophylaxis for recurrent urinary tract infection.
Adherence to intervention was assessed with telephone consults every two months.
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Intervention code [1]
331499
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Prevention
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Intervention code [2]
331572
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Treatment: Drugs
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Comparator / control treatment
Historical control of patient's pre-prophylaxis experience, for the 12 months prior commencing prophylaxis.
For example, for patients commenced intravesical gentamicin for UTI prophylaxis in June 2024, the historical control was that patient's experience June 2023 - June 2024.
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Control group
Historical
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Outcomes
Primary outcome [1]
342169
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For patients with recurrent urinary tract infections (UTI), subjective (patient-reported) rates of UTI per 12-month-equivalent, before versus during treatment.
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Assessment method [1]
342169
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Subjective UTIs were those recalled by the patient during two-monthly telephone follow-up.
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Timepoint [1]
342169
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Every 2 months post enrolment, until census date 01/04/2025
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Primary outcome [2]
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For patients with recurrent urinary tract infections (UTI), objective (positive culture with symptoms) rates of UTI per 12-month-equivalent, before versus during treatment.
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Assessment method [2]
342271
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Objective UTI was defined as a recorded health presentation with symptoms (any of fever, chills, increased bladder spasms, autonomic dysreflexia, altered conscious state or UTI symptoms typical for that patient) plus positive urine culture, defined as >10^3 colony forming units/ mL plus urinary white blood cells. Capture of all such events was based by cross-referencing patient report with the Alberta Health System provincial-wide electronic medical record.
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Timepoint [2]
342271
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Every 2 months post enrolment, until census date 01/04/2025
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Secondary outcome [1]
449802
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For patients with recurrent UTIs, proportion of patients with >=1 UTIs per 12-month-equivalent caused by multi drug-resistant organism, before vs during treatment.
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Assessment method [1]
449802
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Assessed by cross-referencing patient report with the Alberta Health System provincial-wide electronic medical record, to find a matching recorded health presentation with symptoms (any of fever, chills, increased bladder spasms, autonomic dysreflexia, altered conscious state or UTI symptoms typical for that patient) plus positive urine culture.
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Timepoint [1]
449802
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Patients contacted via telephone every two months, between enrolment & study census.
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Secondary outcome [2]
450209
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For patients with recurrent UTIs, proportion of patients with >=1 UTIs per 12-month-equivalent caused by gentamicin-resistant organisms, before vs during treatment.
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Assessment method [2]
450209
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Assessed by cross-referencing patient report with the Alberta Health System provincial-wide electronic medical record, to find a matching recorded health presentation with symptoms (any of fever, chills, increased bladder spasms, autonomic dysreflexia, altered conscious state or UTI symptoms typical for that patient) plus positive urine culture.
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Timepoint [2]
450209
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Patients contacted via telephone every two months, between enrolment & study census.
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Secondary outcome [3]
450210
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For patients with recurrent UTIs, median rates of UTI-related emergency department presentations per 12-month-equivalent, before vs during treatment.
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Assessment method [3]
450210
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Assessed by cross-referencing patient report with the Alberta Health System provincial-wide electronic medical record, to find a matching recorded health presentation with symptoms (any of fever, chills, increased bladder spasms, autonomic dysreflexia, altered conscious state or UTI symptoms typical for that patient) plus positive urine culture.
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Timepoint [3]
450210
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Patients contacted via telephone every two months, between enrolment & study census.
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Secondary outcome [4]
450211
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Patient-reported ease-of-use of intravesical gentamicin
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Assessment method [4]
450211
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Per patient report, using a 1-5 Likert scale
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Timepoint [4]
450211
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Patients contacted via telephone every two months, between enrolment & study census.
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Secondary outcome [5]
450212
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Patient-reported likelihood-to-recommend treatment
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Assessment method [5]
450212
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Per patient report, using a 1-5 Likert scale
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Timepoint [5]
450212
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Patients contacted via telephone every two months, between enrolment & study census.
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Secondary outcome [6]
450213
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Patient reported subjective decrease in urine mal-odour
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Assessment method [6]
450213
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Binary, yes/ no
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Timepoint [6]
450213
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Patients contacted via telephone every two months, between enrolment & study census.
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Secondary outcome [7]
450214
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Patient reported complications, including suprapubic pain, rash or malaise.
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Assessment method [7]
450214
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Telephone consult
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Timepoint [7]
450214
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Patients contacted via telephone every two months, between enrolment & study census.
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Secondary outcome [8]
450215
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For patients with bothersome catheter blockages, median duration (days) between catheter changes
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Assessment method [8]
450215
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Telephone consult
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Timepoint [8]
450215
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Patients contacted via telephone every two months, between enrolment & study census.
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Secondary outcome [9]
450216
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For patients with bothersome catheter blockages, subjective decrease in catheter blocking.
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Assessment method [9]
450216
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Telephone consult, binary yes/ no
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Timepoint [9]
450216
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Patients contacted via telephone every two months, between enrolment & study census.
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Eligibility
Key inclusion criteria
Eligible patients were adults with any form of bladder drainage (spontaneous voiding, clean intermittent catheterisation (CIC), indwelling urethral catheters [IUC] or suprapubic catheters [SPC]) with either recurrent UTIs failing low dose oral prophylaxis (antibiotic or non-antibiotic) and/ or frequent catheter blockages, who received >=14 consecutive days’ once daily intravesical gentamicin in period 01/06/2024 – 01/04/2025, and provided written study consent. A minimum of 14 days’ prophylaxis was selected to mirror criteria of previous studies. Recurrent UTIs were defined as >=2 UTIs in six months or >=3 in twelve months. Frequent catheter blockages were defined as those flagged as bothersome per patient report.
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Minimum age
18
Years
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Maximum age
No limit
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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
Patients who did not complete 14 days’ prophylaxis.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised 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
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
All data was tabulated and presented qualitatively. Primary and secondary outcomes were expected to be non-parametric. Therefore, continuous data such as rate of UTI were summarised as medians and compared between groups using the Kruskal-Wallis/ Mann-Whitney U test. Categorical measures such as Likert score were summarised as proportions, and compared with the Pearson’s chi-squared test.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/07/2024
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Date of last participant enrolment
Anticipated
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Actual
1/04/2025
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
50
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Accrual to date
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Final
42
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Recruitment outside Australia
Country [1]
27224
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Canada
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State/province [1]
27224
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AB
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Funding & Sponsors
Funding source category [1]
319450
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Hospital
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Name [1]
319450
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Rockyview General Hospital
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Address [1]
319450
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Country [1]
319450
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Canada
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Primary sponsor type
University
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Name
University of Calgary
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Address
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Country
Canada
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Secondary sponsor category [1]
321946
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None
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Name [1]
321946
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Address [1]
321946
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Country [1]
321946
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Other collaborator category [1]
283586
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Individual
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Name [1]
283586
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Dr Richard Baverstock, Rockyview General Hospital, Calgary, Canada
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Address [1]
283586
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Country [1]
283586
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Canada
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318030
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Conjoint Health Research Ethics Board (CHREB), University of Calgary
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Ethics committee address [1]
318030
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Conjoint Health Research Ethics Board, Research Services Office, 2500 University Drive NW, Calgary AB T2N 1N4
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Ethics committee country [1]
318030
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Canada
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Date submitted for ethics approval [1]
318030
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01/07/2024
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Approval date [1]
318030
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01/07/2024
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Ethics approval number [1]
318030
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REB24-1642
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Summary
Brief summary
In this prospective single-centre study, patients with recurrent UTIs and/ or catheter blockages were prescribed patient- or carer-administered intravesical gentamicin, nocte, for 6 months, as prophylaxis. The hypothesis was that intravesical gentamicin would decrease rates of UTIs, and potentially also decrease rates of catheter blockages. Compared with pre-treatment, patients on prophylaxis experienced significantly fewer subjective and objective UTIs per 12-month-equivalent. Intravesical gentamicin appears safe and effective prophylaxis for recurrent UTIs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
142894
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Dr Ned Kinnear
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Address
142894
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University of Adelaide, North Terrace, Adelaide, South Australia, 5005
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Country
142894
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Australia
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Phone
142894
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+61 8 8372 7502
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Fax
142894
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Email
142894
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[email protected]
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Contact person for public queries
Name
142895
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Ned Kinnear
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Address
142895
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University of Adelaide, North Terrace, Adelaide, South Australia, 5005
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Country
142895
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Australia
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Phone
142895
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+61 8 8372 7502
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Fax
142895
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Email
142895
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[email protected]
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Contact person for scientific queries
Name
142896
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Ned Kinnear
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Address
142896
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University of Adelaide, North Terrace, Adelaide, South Australia, 5005
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Country
142896
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Australia
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Phone
142896
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+61 8 8182 9000
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Fax
142896
0
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Email
142896
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
•
De-identified individual participant data:
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All outcomes data
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of:
7
years
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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