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Trial registered on ANZCTR


Registration number
ACTRN12609000257268
Ethics application status
Approved
Date submitted
2/02/2009
Date registered
13/05/2009
Date last updated
29/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The first randomised, controlled clinical trial of surgical masks compared to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in hospital health care workers in Beijing, China.
Scientific title
Randomised control trial of health care workers using N95 and surgical masks in prevention of clinical and viral respiratory infection
Secondary ID [1] 288860 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Clinical and viralogical respiratory infection amongst hospital health care workers 4258 0
Condition category
Condition code
Infection 4480 4480 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Surgical masks (Arm 1), N95 masks (fit tested, Arm 2), N95 masks (not fit tested, Arm 3), Control (No masks, Arm 4)
Participants will be provided with surgical masks or N95 masks, (depending on which hospital they work in) to be worn for four weeks when working on the ward. Masks will be worn when participants are working in the emergency department or respiratory ward; they will be allowed to remove the mask when: (1) they exit the department/ward; and (2) enter the tea room for meal breaks.
Subjects recruited to Arm 2 will have the masks correctly fit-tested using a 3M (trademark) FT-30 Bitrex Fit Test Kit according to the manufacturers’ instructions (3M, St Paul, Minnesota (MN), USA). This kit uses a nebulized solution sprayed into an enclosed chamber and relies on the subject tasting the solution through the mask. If the subject is able to taste the solution, the mask is incorrectly fitted and needs to be re-fitted until the subject cannot taste the solution.
All participants will be followed up for five weeks (which includes four weeks of wearing the masks and an extra week of non-mask wearing)
Intervention code [1] 3980 0
Prevention
Comparator / control treatment
No masks
Control group
Active

Outcomes
Primary outcome [1] 5360 0
Clinical respiratory infection
Outcome will be assessed through daily monitoring by study staff
Timepoint [1] 5360 0
Daily for five weeks
Primary outcome [2] 5361 0
Laboratory confirmed viral respiratory infection
Timepoint [2] 5361 0
Daily for five weeks
Primary outcome [3] 5362 0
Adherence with mask use, and variance in adherence with duration of enrolment.
Outcome will be assessed through daily monitoring by study staff and by the use of a daily diary completed by the participant
Timepoint [3] 5362 0
Daily for four weeks
Secondary outcome [1] 9010 0
Time from recruitment of an enrolled subject to infection with an clinical respiratory infection
Outcome will be assessed through daily monitoring by study staff
Timepoint [1] 9010 0
Daily for five weeks

Eligibility
Key inclusion criteria
Any nurse or doctor who works full time in the selected ward at the study hospitals in Beijing, China.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability or refusal to consent
Males with beards, long moustaches or long facial hair stubble
Clinical staff with a current respiratory illness, rhinitis and/or allergy
Part-time worker
Does not work on the abovementioned wards

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)
The study was cluster randomised with the hospital being the unit of randomisation. Health workers in emergency, paediatric and respiratory wards were included. The study coordinator provided information about the study and recruited participants. Consenting staff were evaluated for signs and symptoms of influenza at baseline (against a checklist of standard signs and symptoms used for defining clinical respiratory illness (CRI)). Eligible subjects were then be randomized to the intervention arms (Surgical masks, N95 (fit tested), N95 (non fit tested). Blinding was not possible because of the nature of the intervention, however, laboratory testing will be blinded. Controls were selected prospectively from a convenience sample of health care workers in hospitals where mask wearing was uncommon. This is because mask wearng is very common in Beijing, and a control arm was unacceptable to health workers in most hospitals.
Recruitment commenced on December 1st 2008.
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation program was designed in Microsoft access
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2008
Actual
1/12/2008
Date of last participant enrolment
Anticipated
5/12/2008
Actual
19/12/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
1600
Accrual to date
Final
1441
Recruitment outside Australia
Country [1] 1555 0
China
State/province [1] 1555 0
Beijing

Funding & Sponsors
Funding source category [1] 4437 0
University
Name [1] 4437 0
University of New South Wales
Country [1] 4437 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Samuels Building, University of New South Wales
Botany St
Randwick, 2031
NSW, Australia
Country
Australia
Secondary sponsor category [1] 3998 0
Government body
Name [1] 3998 0
Beijing Centers for Disease Control and Prevention
Address [1] 3998 0
No. 16 He Pingli Middle Street, Dong Cheng District, Beijing, 100013, China
Country [1] 3998 0
China
Other collaborator category [1] 545 0
Hospital
Name [1] 545 0
Westmead Hospital
Address [1] 545 0
Institute of Clinical Pathology and Medical Research (ICPMR), Westmead Hospital, Westmead,
NSW, Australia 2145
Country [1] 545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6488 0
Beijing Center for Disease Prevention and Control Medical Ethics Committee
Ethics committee address [1] 6488 0
Ethics committee country [1] 6488 0
China
Date submitted for ethics approval [1] 6488 0
12/07/2008
Approval date [1] 6488 0
02/10/2008
Ethics approval number [1] 6488 0
2008/2/2

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29238 0
Prof Raina MacIntyre
Address 29238 0
Samuels Building, University of New South Wales Botany St Randwick, 2031 NSW, Australia
Country 29238 0
Australia
Phone 29238 0
+61 2 9385 2517
Fax 29238 0
Email 29238 0
[email protected]
Contact person for public queries
Name 12485 0
Dr Holly Seale
Address 12485 0
Samuels Building, University of New South Wales
Botany St
Randwick, 2031
NSW, Australia
Country 12485 0
Australia
Phone 12485 0
+61 2 9385 3129
Fax 12485 0
+61 2 9313 6185
Email 12485 0
[email protected]
Contact person for scientific queries
Name 3413 0
Professor Raina MacIntyre
Address 3413 0
Samuels Building, University of New South Wales
Botany St
Randwick, 2031
NSW, Australia
Country 3413 0
Australia
Phone 3413 0
+61 2 9385 3811
Fax 3413 0
+61 2 9313 6185
Email 3413 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
SourceTitleYear of PublicationDOI
EmbaseA 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.2011https://dx.doi.org/10.1111/j.1750-2659.2011.00198.x
EmbaseHerd protection effect of N95 respirators in healthcare workers.2017https://dx.doi.org/10.1177/0300060516665491
N.B. These documents automatically identified may not have been verified by the study sponsor.