Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12607000314426
Ethics application status
Approved
Date submitted
8/06/2007
Date registered
13/06/2007
Date last updated
29/07/2024
Date data sharing statement initially provided
29/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, controlled trial of mask use in control of respiratory virus transmission in Health Care Workers
Scientific title
A Randomised, controlled trial of mask use in control of respiratory virus transmission in Health Care Workers
Secondary ID [1] 312637 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory infections (laboratory confirmed) 1858 0
Respiratory infections (clinical case definition) 334597 0
Condition category
Condition code
Respiratory 1952 1952 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 1815 0
Prevention
Comparator / control treatment
No masks (control).
Control group
Active

Outcomes
Primary outcome [1] 2771 0
Laboratory confirmed viral respiratory infection reported in HCW
Timepoint [1] 2771 0
Within the four week follow up period
Secondary outcome [1] 4666 0
Influenza like illness (clinical) reported in HCW
Timepoint [1] 4666 0
Within the four week follow up period

Eligibility
Key inclusion criteria
Must not have had any influenza like illness within a week prior to recruitment. Must sign the consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Beard or facial hair

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)
Secure computer randomisation program
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software program
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2006
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
15/01/2009
Date of last data collection
Anticipated
Actual
30/01/2009
Sample size
Target
500
Accrual to date
Final
1441
Recruitment outside Australia
Country [1] 26480 0
China
State/province [1] 26480 0
Beijing

Funding & Sponsors
Funding source category [1] 2095 0
Government body
Name [1] 2095 0
The Office Of Health Protection, Department of Health and Ageing, Australian government
Country [1] 2095 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Country
Australia
Secondary sponsor category [1] 1901 0
Government body
Name [1] 1901 0
The Office Of Health Protection, Department of Health and Ageing
Address [1] 1901 0
Country [1] 1901 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3885 0
The Children's Hospital at Westmead
Ethics committee address [1] 3885 0
Email: [email protected] (preferred)

Phone: 7825 1253

Mailing Addresses:

The Children’s Hospital at Westmead, Kids Research Building, Corner Hawkesbury Road and Hainsworth Street, Westmead NSW 2145.
Locked Bag 4001, Westmead NSW 2145
Ethics committee country [1] 3885 0
Australia
Date submitted for ethics approval [1] 3885 0
Approval date [1] 3885 0
04/08/2006
Ethics approval number [1] 3885 0
00005163

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.
Trial website
Trial related presentations / publications
MacIntyre et al. (2011) A cluster randomized clinical trial comparing fit-tested and non-fit-tested N95 respirators to medical masks
to prevent respiratory virus infection in health care workers. Influenza and Other Respiratory Viruses 5(3), 170–179.
Public notes

Contacts
Principal investigator
Name 27629 0
C Raina MacIntyre
Address 27629 0
Biosecurity Program
Kirby Institute
Level 6, Wallace Wurth Building
UNSW SYDNEY 2052
Country 27629 0
Australia
Phone 27629 0
+6102 9385 0874
Fax 27629 0
Email 27629 0
[email protected]
Contact person for public queries
Name 11004 0
Holly Seale
Address 11004 0
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
Country 11004 0
Australia
Phone 11004 0
+61 2 98450134
Fax 11004 0
+61 2 98451418
Email 11004 0
[email protected]
Contact person for scientific queries
Name 1932 0
Holly Seale
Address 1932 0
School of Population Health,
UNSW
Country 1932 0
Australia
Phone 1932 0
+61 2 98450134
Fax 1932 0
+61 2 98451418
Email 1932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.