Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000670077
Ethics application status
Not yet submitted
Date submitted
12/08/2010
Date registered
16/08/2010
Date last updated
16/08/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Establishing the occurence of non-O157 verocytotoxic Escherichia coli (VTEC) in New Zealand farming population using molecular and culture-based methods.
Scientific title
Establishing the occurence of non-O157 verocytotoxic Escherichia coli (VTEC) in patients presenting with sudden onset of diarrhoea in a New Zealand farming population using molecular and culture-based methods.
Secondary ID [1] 252433 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastroenteritis 257945 0
Condition category
Condition code
Oral and Gastrointestinal 258112 258112 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The overall study period will be for 8 months. The trial will consist in obtaining faecal samples from an hospital laboratory which will then be sent to us for testing. The first phase will concist in an initial screen of the samples for VTEC using molecular methods. If the molecular scree is positive then the second phase will consist in isolating and characterising the VTEC from the faecal sample.
Intervention code [1] 257000 0
Early detection / Screening
Intervention code [2] 257020 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258976 0
Establish occurence of non-O157 VTEC in New Zealand.The first phase of this project will look at optimising
(a) molecular-based methods for the detection of non-O157 STEC from clinical samples, and
(b) culture-based methods for the isolation of non-O157 STEC.
The second phase of this project will apply these methods to the screening of clinical samples obtained from a hospital
laboratory.
Timepoint [1] 258976 0
At the end of the clinical trial (at the end of the 8 months)
Secondary outcome [1] 265165 0
From the results obtained from the clinical trial we will be able to draw recommendations in the form of a final report as to which methods to use for the detection and isolation of non-O157 VTEC.
Timepoint [1] 265165 0
At the end of the clinicla trial (Will be in June 2011)

Eligibility
Key inclusion criteria
faecal samples submitted for general gastroenteritis screen and from HUS patients
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No clearance samples

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 2819 0
New Zealand
State/province [1] 2819 0

Funding & Sponsors
Funding source category [1] 257450 0
Government body
Name [1] 257450 0
Ministry of Research, Science and Technology
Country [1] 257450 0
New Zealand
Primary sponsor type
Government body
Name
Institue of Environmental Science and Research Ltd (ESR)
Address
Kenepuru Science Centre
PO Box 50348
34 Kenepuru Drive
Porirua 5022
New Zealand
Country
New Zealand
Secondary sponsor category [1] 256681 0
None
Name [1] 256681 0
Address [1] 256681 0
Country [1] 256681 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259478 0
Ethics committee address [1] 259478 0
Ethics committee country [1] 259478 0
New Zealand
Date submitted for ethics approval [1] 259478 0
27/08/2010
Approval date [1] 259478 0
Ethics approval number [1] 259478 0

Summary
Brief summary
The faecal samples provided by volunteers will contribute to the research on toxigenic Escherichia coli also known as verocytotoxic E. coli or VTEC. They are over 150 different serotypes of VTEC which have been associated with diseases. The O157 serotype has been recognised since the 1980s as an important human pathogen causing outbreak overseas and serious sequalae such as haemolytic uremic syndrome or HUS. In New Zealand, O157 VTEC represent a significant burden and hospital, private and community laboratories have to report any case of O157 VTEC they detect. The other serotypes which are referred to as the non-O157 VTEC have become as important as the O157 VTEC in some overseas countries. In New Zealand, however, the true incidence of non-O157 VTEC is unknown as no routine surveillance is undertaken. This project will initially look at optimising the methods to detect and isolate VTEC. A clinical trial will then be undertaken which will look at (approximately)150 faecal samples from patients in the Waikato region. This pilot study will allow us to establish whether or not these non-O157 VTEC represent a health problem in New Zealand.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31516 0
Address 31516 0
Country 31516 0
Phone 31516 0
Fax 31516 0
Email 31516 0
Contact person for public queries
Name 14763 0
Muriel Dufour
Address 14763 0
Institute of Environmental Science adn Research Ltd, National Centre for Biosecurity and Infectious Disease (ESR-NCBID) - Wallaceville
66 Ward Street
PO Box 40158
Upper Hutt 5018
New Zealand
Country 14763 0
New Zealand
Phone 14763 0
00 64 4 529 0607
Fax 14763 0
Email 14763 0
muriel.dufour@esr.cri.nz
Contact person for scientific queries
Name 5691 0
Muriel Dufour
Address 5691 0
ESR-NCBID - Wallaceville
66 Ward Street
PO Box 40158
Upper Hutt 5018
New Zealand
Country 5691 0
New Zealand
Phone 5691 0
00 64 4 529 0607
Fax 5691 0
Email 5691 0
muriel.dufour@esr.cri.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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