Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Epidemiology of Q fever within the Mackay Health District over the last 10 years.
Secondary ID [1] 284997 0
Nil
Universal Trial Number (UTN)
U1111-1159-3708
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Q Fever 292503 0
Condition category
Condition code
Infection 292812 292812 0 0
Other infectious diseases
Public Health 293000 293000 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 289832 0
Not applicable
Comparator / control treatment
Nil treatment provided as it is a questionnaire
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292669 0
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.
Timepoint [1] 292669 0
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.
Secondary outcome [1] 309466 0
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.
Timepoint [1] 309466 0
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.

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
Minimum age
18 Years
Maximum age
150 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 with serological positive Q fever

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/07/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289613 0
Hospital
Name [1] 289613 0
Queensland Private Fund Trust (Mackay Base Hospital, QLD)
Country [1] 289613 0
Australia
Primary sponsor type
Individual
Name
Pirathaban Sivabalan
Address
2 Griffin Street, Mackay, QLD, 4740
James Cook University
Country
Australia
Secondary sponsor category [1] 288299 0
Individual
Name [1] 288299 0
Apoorva Saboo
Address [1] 288299 0
Apoorva Saboo
James Cook University
PO BOX 6314
Mackay Mail Centre
QLD 4741
Country [1] 288299 0
Australia

Ethics approval
Ethics application status
Approved

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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 161 161 0 0
/AnzctrAttachments/366736-newly revised ID Questionnaire version 2.docx

Contacts
Principal investigator
Name 50002 0
Mr Pirathaban Sivabalan
Address 50002 0
2 Griffin Street, Mackay, QLD, 4740
James Cook University
Country 50002 0
Australia
Phone 50002 0
61432472026
Fax 50002 0
Email 50002 0
[email protected]
Contact person for public queries
Name 50003 0
Apoorva Saboo
Address 50003 0
Apoorva Saboo
James Cook University
PO BOX 6314
Mackay Mail Centre
QLD 4741
Country 50003 0
Australia
Phone 50003 0
61451045880
Fax 50003 0
Email 50003 0
[email protected]
Contact person for scientific queries
Name 50004 0
Apoorva Saboo
Address 50004 0
Apoorva Saboo
James Cook University
PO BOX 6314
Mackay Mail Centre
QLD 4741
Country 50004 0
Australia
Phone 50004 0
61451045880
Fax 50004 0
Email 50004 0
[email protected]

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.