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Trial registered on ANZCTR
Registration number
ACTRN12607000314426
Ethics application status
Approved
Date submitted
8/06/2007
Date registered
13/06/2007
Date last updated
13/06/2007
Type of registration
Retrospectively registered
Titles & IDs
Public title
A Randomised, controlled trial of mask use in control of respiratory virus transmission in Health Care Workers
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Scientific title
A Randomised, controlled trial of mask use in control of respiratory virus transmission in Health Care Workers
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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:
Prevention of respiratory infections by face masks
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Condition category
Condition code
Respiratory
1952
1952
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0
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Normal development and function of the respiratory system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Surgical masks, P2 particulate respirators. The health care worker (HCW) will be asked to wear the mask when they are within 1 metre of a child with respiratory symptoms, for four weeks.
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Intervention code [1]
1815
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Prevention
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Comparator / control treatment
No masks (control).
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Control group
Active
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Outcomes
Primary outcome [1]
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Laboratory confirmed viral respiratory infection reported in HCW
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Assessment method [1]
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Timepoint [1]
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Within the four week follow up period
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Secondary outcome [1]
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Influenza like illness (clinical) reported in HCW
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Assessment method [1]
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Timepoint [1]
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Within the four week follow up period
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Eligibility
Key inclusion criteria
Must not have had any influenza like illness within a week prior to recruitment. Must sign the consent form.
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Secure computer randomisation program
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software program
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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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/08/2006
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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
100
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Accrual to date
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Final
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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The Office Of Health Protection, Department of Health and Ageing, Australian government
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
The Children's Hospital at Westmead
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Address
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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The Office Of Health Protection, Department of Health and Ageing
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Address [1]
1901
0
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Country [1]
1901
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Children's Hospital at Westmead
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Ethics committee address [1]
3885
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Ethics committee country [1]
3885
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Australia
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Date submitted for ethics approval [1]
3885
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Approval date [1]
3885
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04/08/2006
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Ethics approval number [1]
3885
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00005163
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Summary
Brief summary
Influenza (the flu) causes a lot of sickness in the winter, and can sometimes cause death. It causes more sickness and death than any other infectious disease in Australia. Current flu control measures include the flu vaccine and antivirals. Although it is believed that other measures such as hand washing/drying and wearing masks and/or gloves help to slow down the spread of the flu virus and other respiratory viruses, experts don’t know how effective face masks really are. This is important to know to protect people both during the annual flu season and in the case of pandemic influenza.
By doing this study, we want to find how well face masks stop the spread of flu and other respiratory virus infections. We also want to know if there is a difference between ordinary paper face masks (surgical masks) and special face masks called “P2” masks, which are thought to be (but not proven to be) more protective than ordinary paper face masks. We will be studying this question in health care staff working in the emergency department and wards of a hospital.
Health care workers have a bigger chance of coming in contact with children suffering respiratory infections and contracting a respiratory illness as a result. The study will allow the evaluation of the mask as a protective measure against respiratory illness.
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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
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Holly Seale
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Address
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National Centre for Immunisation Research
Children's Hospital at Westmead
National Centre for Immunisation Research and Surveillance (NCIRS)
Level 2
Kerry Packer Institute for Child Health Research
Children's Hospital at Westmead
Westmead NSW 2145
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Country
11004
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Australia
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Phone
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+61 2 98450134
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Fax
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+61 2 98451418
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Email
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[email protected]
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Contact person for scientific queries
Name
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Holly Seale
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Address
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National Centre for Immunisation Research
Children's Hospital at Westmead
National Centre for Immunisation Research and Surveillance (NCIRS)
Level 2
Kerry Packer Institute for Child Health Research
Children's Hospital at Westmead
Westmead NSW 2145
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Country
1932
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Australia
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Phone
1932
0
+61 2 98450134
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Fax
1932
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+61 2 98451418
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Email
1932
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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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