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Trial registered on ANZCTR
Registration number
ACTRN12614000878673
Ethics application status
Approved
Date submitted
3/08/2014
Date registered
19/08/2014
Date last updated
19/08/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
Q fever within the Mackay Health District
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Scientific title
Epidemiology of Q fever within the Mackay Health District over the last 10 years.
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Secondary ID [1]
284997
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Nil
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Universal Trial Number (UTN)
U1111-1159-3708
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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:
Q Fever
292503
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Condition category
Condition code
Infection
292812
292812
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0
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Other infectious diseases
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Public Health
293000
293000
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0
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Epidemiology
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
We are doing a retrospective study of the patients who have developed Q fever within last 10 years. We are looking at patients demographic profile, their previous medical conditions/surgeries/medication, their exposure risk factors (such as their property size, their occupation, their fence size, their exposure to animals), social history (drinking/smoking habits), and treatment they received for infection. This will be answered via a simple questionnaire, hopefully over the next few months. Patients complete questionnaire only once, and information provided within their answers should only be before or at time of diagnosis.
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Intervention code [1]
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Not applicable
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Comparator / control treatment
Nil treatment provided as it is a questionnaire
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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A validated questionnaire is being used to study the exposure risks. The name of the questionnaire is Q fever questionnaire which have both been approved by Townsville Human Research Ethics committee and Communicable Disease Unit in Townsville (see questionnaire which is attached to this registration record on the ANZCTR). This questionnaire was made by our own research group. These include their property size and fencing, their previous medical and surgical conditions, their medication, their occupation and exposure to any animals, and their drinking/smoking habits.
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Assessment method [1]
292669
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Timepoint [1]
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We have been granted approval by communicable disease unit and Townsville Human Research Ethics committee to have access to all patients who have developed Q fever within the last 10 years. Thus outcomes for each patient are assessed when they contracted the disease. Usually there a few cases annually. This information will be collected retrospectively via the questionnaire.
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Secondary outcome [1]
309466
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Study any underlying predisposing conditions for developing Q fever. These include diabetes, respiratory conditions such chronic obstructive pulmonary disease, cardiac conditions such as ischaemic heart disease or cardiac failure, immunocomprimised patients, pregnancy, liver disease, bone marrow diseases etc. We have created a data collection tool appropriate for our questionnaire, which is made via excel spreadsheet. From this data tool we will be able to graph, tabulate or use statistics to help us understand the epidemiological profile of the patients who have contracted Q fever within Mackay Health District, which may lead to understand any trends in developing the disease.
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Assessment method [1]
309466
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Timepoint [1]
309466
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It depends on when the patient contracted the infection (which is released by the communicable disease unit), and the patient will write this in on their questionnaire. Data will be collected retrospectively via the questionnaire that will be sent out to participants.
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Eligibility
Key inclusion criteria
all patients aged over 18 who have been reported as serologically positive for Q fever within Mackay Health district over the last 10 years
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Minimum age
18
Years
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Maximum age
150
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
Patients under 18 with serological positive Q fever
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
As it is an epidemiological study, we only needed the patients who have been reported to communicable disease unit for a positive serology for Q fever. We will be using simple demographical statistics (via Microsoft excel) with the aid of graphs, and tables to help evaluate and present our statistics.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
15/07/2014
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Actual
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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
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Actual
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Sample size
Target
90
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Queensland Private Fund Trust (Mackay Base Hospital, QLD)
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Address [1]
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475 Bridge Road, West Mackay, 4740, QLD
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Pirathaban Sivabalan
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Address
2 Griffin Street, Mackay, QLD, 4740
James Cook University
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Apoorva Saboo
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Address [1]
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Apoorva Saboo
James Cook University
PO BOX 6314
Mackay Mail Centre
QLD 4741
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Country [1]
288299
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Australia
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Q fever is a zoonotic disease caused by the highly infectious agent Coxiella Burnetti. This agent is transmitted via animal’s urine, faeces and bodily fluids in which they dry up and become contaminated dust in air. Humans contract this intracellular bacterium via the respiratory route, as they breathe the contaminated air. Literature provides some ideas on the exposure risks for developing Q fever such as; being a farmer, sheep and dairy workers, veterinarians, laboratory workers, and many more. However not much has been shown on specific animals transmitting Q fever, especially the comparison of the well-established risk of exposure to cattle verse the native mammals such as macropods. In addition acute Q fever can develop into chronic Q fever within some patients, thus creating an array of complications such as endocarditis, pneumonia, hepatitis, pregnancy related problems, and meningitis. These complications delineate the importance of identifying the exposure risks in order to develop possible preventative regimes against Q fever. In the setting of a regional and rural population consisting of approximately 160,000 people which is mainly known for its’ mining, farming, cane-farming industry as well as its’ diverse native fauna, it is interesting in analysing the different exposure risks for developing Q fever. This exposure ranges from contact with different animals (such as sheep, cattle, macropods), living in different climates (such as wet and dry season) and those within different professions (such as farming, cane-farming, meat workers, veterinarians, laboratory workers). In addition, the study will hopefully illustrate any underlying medical conditions which may predispose patients to contracting Q fever. Researching both of these outcomes will help create a risk profile for humans in developing Q fever.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
161
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/AnzctrAttachments/366736-newly revised ID Questionnaire version 2.docx
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Contacts
Principal investigator
Name
50002
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Mr Pirathaban Sivabalan
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Address
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2 Griffin Street, Mackay, QLD, 4740
James Cook University
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Country
50002
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Australia
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Phone
50002
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61432472026
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Fax
50002
0
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Email
50002
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[email protected]
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Contact person for public queries
Name
50003
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Apoorva Saboo
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Address
50003
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Apoorva Saboo
James Cook University
PO BOX 6314
Mackay Mail Centre
QLD 4741
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Country
50003
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Australia
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Phone
50003
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61451045880
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Fax
50003
0
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Email
50003
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[email protected]
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Contact person for scientific queries
Name
50004
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Apoorva Saboo
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Address
50004
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Apoorva Saboo
James Cook University
PO BOX 6314
Mackay Mail Centre
QLD 4741
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Country
50004
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Australia
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Phone
50004
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61451045880
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Fax
50004
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Email
50004
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[email protected]
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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
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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