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Trial registered on ANZCTR


Registration number
ACTRN12608000470392
Ethics application status
Approved
Date submitted
17/08/2005
Date registered
17/08/2005
Date last updated
30/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A placebo controlled randomized trial of long-term antibiotics to prevent recurrent urinary tract infection in children
Scientific title
A trial of long term cotrimoxazole compared to placebo to prevent recurrent urinary tract infection in children
Secondary ID [1] 288034 0
nil known
Universal Trial Number (UTN)
Trial acronym
PRIVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary tract infection 3718 0
Condition category
Condition code
Renal and Urogenital 3889 3889 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low dose continuous, daily, cotrimoxazole for 12 months. Oral route. Dose is calculated by volume according to body weight; 2mg/kg of Trimethoprim and 10mg/kg sulphamethoxazole. This works out to be 0.25mL/kg of 200-40mg/5mL suspension. Dose is increased every 3 months to the nearest 0.5mL as the child grows. Children take medication once per day for 12 months.
Intervention code [1] 3446 0
Prevention
Comparator / control treatment
Placebo, taste and colour matched to active. Oral route, once daily for 12 months. Placebo is liquid, colour and taste matched to active treatment. Made specifically for this trial by accredited laboratory. 0.25mL/kg as single daily dose, increased every 3 months to nearest 0.5mL. This is identical to the volume given in the active treatment arm.
Control group
Placebo

Outcomes
Primary outcome [1] 4788 0
Repeat symptomatic microbiologically proven urinary tract infection. Measured by direct questioning of parents at 3, 6, 9 and 12 month clinic reviews. Any parent stating yes to a urinary tract infection is asked for consent to contact primary care giver and obtain details. Trial coordinators at each centre contact health providers and obtain a copy of microbioligucal report on the urine culture.
Timepoint [1] 4788 0
3, 6, 9 and 12 month followup
Secondary outcome [1] 8102 0
Febrile urinary tract infection. Measured by direct questioning of parent at 3,6,9 and 12 month time points and verified with appropriate health care providers record of microbiological result
Timepoint [1] 8102 0
Asked at 3, 6, 9 and 12 months. Covers the period 0-12 months
Secondary outcome [2] 8103 0
Hospitalisation. Measured by direct questioning of parent at 3,6,9 and 12 month time points
Timepoint [2] 8103 0
Asked at 3, 6, 9 and 12 months, covers the period 0-12 months
Secondary outcome [3] 8104 0
Adverse drug reactions. Measured by direct questioning of parent at 3,6,9 and 12 month time points. Questioned about occurrences of; diarrhoea, nausea, vomitting, rash, thrush, jaundice, anaphylaxis, haematoligic abnormalities
Timepoint [3] 8104 0
0-12 months, asked at 3, 6, 9 and 12 month reviews
Secondary outcome [4] 8105 0
Antibiotic administration for other infectious disease. Measured by direct questioning of parents at 3, 6, 9 and 12 month clinic reviews
Timepoint [4] 8105 0
0 -12 months, questioned at 3, 6, 9 and 12 month clinic review
Secondary outcome [5] 8106 0
Abnorrmalities on dimercaptosuccinic acid scan (DMSA). Children with abnormal initial DMSA scans are requested to undergo a repeat DMSA at 12 months. All DMSA scans are centrally re-reported by one Senior Staff Specialist in nuclear medicine at The Children's Hospital at Westmead (CHW). DMSA scans at 12 months are compared to initial scans and the single CHW reviewer codes the scans as to whether they are ; unchanged, partial improvement, complete improvement and no change.
Timepoint [5] 8106 0
Baseline, 12 months

Eligibility
Key inclusion criteria
Children <18 years, symptomatic microbiologically proven urinary tract infection
Minimum age
0 Days
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Asymptomatic urinary tract infection, Non-recurrent urinary tract infection in children > 5 years, Bag urine sample, growth below threshold, not pure growth, predisposing causes; indwelling catheter, nosocomial infection, urological/nephrological disease (renal disese, pelviureteric obstruction, vesicoureteral obstruction, posterior urethral valves, renal tract malformations, renal calculi), neurological problems (spina bifida, spina cord injuries, neurogenic bladder, cerebral palsy) Glucose 6 phosphate dehydrogenase deficiency, sulphur allergy, non-resident of Australia

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation by National Health and Medical Research Council (NHMRC) trial centre, Stratified by centre, referral course, frequency of prior UTIs, presen or absence of reflux, age and gender by the method of minimisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Taste and colour matched placebo. run-in period of active treament for 2 weeks. Compliance assesed prior to randomisation. Compliance measured by direct questioning and measured by amount of medication remaining in bottle at each 3 monthly review
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1159 0
1860
Recruitment postcode(s) [2] 1160 0
2037
Recruitment postcode(s) [3] 1161 0
2041
Recruitment postcode(s) [4] 1162 0
2037
Recruitment postcode(s) [5] 1163 0
2045
Recruitment postcode(s) [6] 1164 0
2037

Funding & Sponsors
Funding source category [1] 3900 0
Government body
Name [1] 3900 0
National Health and Medical Research Council (NHMRC) of Australia
Address [1] 3900 0
GPO Box 1421, Canberra, ACT 2601
Country [1] 3900 0
Australia
Funding source category [2] 3901 0
Charities/Societies/Foundations
Name [2] 3901 0
Financial Markets Foundation of Australia
Address [2] 3901 0
GPO Box 3655 Sydney NSW 1044
Country [2] 3901 0
Australia
Funding source category [3] 3902 0
Other
Name [3] 3902 0
JT Honan, Manildra Holdings
Address [3] 3902 0
Private Donation, Manildra Holdings Level 12, 72 Castlereagh Street, Sydney NSW, 2000
Country [3] 3902 0
Australia
Primary sponsor type
Hospital
Name
The Childrens Hospital at Westmead
Address
Locked bag 4001, Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 3501 0
University
Name [1] 3501 0
University of Sydney
Address [1] 3501 0
Camperdown, NSW 2006
Country [1] 3501 0
Australia
Other collaborator category [1] 424 0
University
Name [1] 424 0
Australian National University Medical School
Address [1] 424 0
Frank Fenner Building 42, The Australian National University, Canberra, ACT 0200
Country [1] 424 0
Australia
Other collaborator category [2] 425 0
University
Name [2] 425 0
University of Queensland
Address [2] 425 0
Level 3 Foundation Building, Herston Road, Brisbane, Queensland 4029
Country [2] 425 0
Australia
Other collaborator category [3] 426 0
Hospital
Name [3] 426 0
Royal Childrens Hospital
Address [3] 426 0
50 Flemington Road, Parkville, Melbourne, Victoria 3052
Country [3] 426 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5951 0
Royal Alexandra Hospital for Children, The New Childrens Hospital
Ethics committee address [1] 5951 0
Locked Bag 4001, Wetmead NSW 2145
Ethics committee country [1] 5951 0
Australia
Date submitted for ethics approval [1] 5951 0
05/12/1996
Approval date [1] 5951 0
20/12/1996
Ethics approval number [1] 5951 0
96081, renewed 2002/051
Ethics committee name [2] 5952 0
The University of Sydney Human research Ethics committee
Ethics committee address [2] 5952 0
Main Quadrangle, University of Sydney, Camperdown, NSW 2006
Ethics committee country [2] 5952 0
Australia
Date submitted for ethics approval [2] 5952 0
09/09/2001
Approval date [2] 5952 0
04/02/2002
Ethics approval number [2] 5952 0
01/09/26
Ethics committee name [3] 5953 0
Wentworth Area Health Service Ethics Committee
Ethics committee address [3] 5953 0
Court Buliding PO Box 63 Penrith NSW 2751
Ethics committee country [3] 5953 0
Australia
Date submitted for ethics approval [3] 5953 0
31/03/2004
Approval date [3] 5953 0
13/04/2004
Ethics approval number [3] 5953 0
03/016
Ethics committee name [4] 5954 0
Royal CHildrens Hospital, Melbourne Ethics in Human Research Committee
Ethics committee address [4] 5954 0
50 Flemington Road Parkville Victoria 3052
Ethics committee country [4] 5954 0
Australia
Date submitted for ethics approval [4] 5954 0
01/02/2002
Approval date [4] 5954 0
05/03/2002
Ethics approval number [4] 5954 0
22007A, 22007P
Ethics committee name [5] 5955 0
Royal Childrens Hospital and Health Service District Ethics Committee
Ethics committee address [5] 5955 0
RCH Foundation Building, Royal Childrens Hospital, Herston Road, Brisbane, Queensland 4029
Ethics committee country [5] 5955 0
Australia
Date submitted for ethics approval [5] 5955 0
01/04/2005
Approval date [5] 5955 0
20/05/2005
Ethics approval number [5] 5955 0
6/10/05
Ethics committee name [6] 5956 0
ACT Health Human Research Ethics Committee
Ethics committee address [6] 5956 0
GPO Box 825 Canberra ACT
Ethics committee country [6] 5956 0
Australia
Date submitted for ethics approval [6] 5956 0
01/02/2000
Approval date [6] 5956 0
13/03/2000
Ethics approval number [6] 5956 0
ETH.2/00.54 refers

Summary
Brief summary
This is a multi-centre, blinded placebo-controlled randomised trial of long-term antibiotics in children. Patients will be randomly allocated to either low dose cotrimoxazole or placebo and followed for 12 months. Randomisation will be performed centrally by the NHMRC Clinical Trials Centre with dynamic balancing of important confounders and stratified by vesicoureteric reflux. Treatment allocation will be concealed. A total of 780 participants will be drawn from children routinely given long-term antibiotics, either because of their age (infants), what is thought to be a predisposing abnormality (vesicoureteric reflux), or because of recurrent infections. Children will be monitored at 3, 6, 9 and 12 month clinics. The primary outcome is repeat symptomatic microbiologically proven urinary tract infection
Trial website
http://www.kidney-research.org/privent.html
Trial related presentations / publications
N Engl J Med 2009;361:1748-59.
Public notes

Contacts
Principal investigator
Name 28953 0
Prof Jonathan Craig
Address 28953 0
The Childrens Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145
Country 28953 0
Australia
Phone 28953 0
0298451492
Fax 28953 0
Email 28953 0
jonathan.craig@sydney.edu.au
Contact person for public queries
Name 12110 0
Prof Professor Jonathan Craig
Address 12110 0
The Childrens Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145
Country 12110 0
Australia
Phone 12110 0
0298453431
Fax 12110 0
0298451491
Email 12110 0
jonathan.craig@sydney.edu.au
Contact person for scientific queries
Name 3038 0
Prof Professor Jonathan Craig
Address 3038 0
The Childrens Hospital at Westmead, Locked Bag 4001, Westmead, NSW 2145
Country 3038 0
Australia
Phone 3038 0
0298453431
Fax 3038 0
0298451491
Email 3038 0
jonathan.craig@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary