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Trial registered on ANZCTR


Registration number
ACTRN12609000778280
Ethics application status
Approved
Date submitted
4/09/2009
Date registered
8/09/2009
Date last updated
29/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of face masks against H1N1 swine influenza
Scientific title
A randomised clinical trial of respirators and surgical masks in the prevention of H1N109 and respiratory pathogen infection in Chinese healthcare workers
Secondary ID [1] 280478 0
NA.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pandemic (H1N1) 2009, seasonal influenza, viral or bacterial respiratory infections 243666 0
Condition category
Condition code
Infection 239936 239936 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm One: N95 respirator
Respirators are personal protective fitted devices that cover the nose and mouths and operate by purifying the air inhaled by the wearer through filtering materials.
In this trial, participants will be asked to wear the respirator continuously on every shift (around 8 hours) over the four week period. They are to remove the respirator when: they exit the department/ward or when they enter the tea room for a break.
Intervention code [1] 241216 0
Prevention
Comparator / control treatment
Arm 2: Surgical masks-are loose-fitting facial coverings that are designed to prevent wound contamination in the patient from the cough or exhaled secretions of the physician, nurse or other healthcare worker. In this trial, participants will be asked to wear the surgical mask continuously on every shift (around 8 hours) over the four week period. They are to remove the mask when: they exit the department/ward or when they enter the tea room for a break.
Arm 3: N95 respirator-Participants in this arm will be asked to wear a respirator only when they are involved with a high risk procedure (HRP) (aerosol generating) or when they are caring for a patient with influenza-like-illness (ILI). They will be asked to remove the respirator when they have completed the HRP or when they have finished caring for the patient with ILI.
Control group
Active

Outcomes
Primary outcome [1] 240736 0
Clinical respiratory illness (CRI): defined as two or more respiratory or systemic symptoms
Timepoint [1] 240736 0
The outcome of the study will be assessed on a daily basis over the five week period. Time to development of outcome will be measured
Primary outcome [2] 253131 0
Influenza-like illness (ILI): defined as fever >38C plus one respiratory symptom
Timepoint [2] 253131 0
The outcome of the study will be assessed on a daily basis over the five week period. Time to development of outcome will be measured
Primary outcome [3] 253132 0
Laboratory-confirmed viral or bacterial respiratory infection: adenoviruses, human metapneumovirus, influenza A or B, pandemic (H1N1) 2009 influenza, coronaviruses 229E/NL63, parainfluenzaviruses 1, 2 and 3, respiratory syncytial virus A and B, rhinovirus A/B and coronavirus OC43/HKU1, streptococcus pneumoniae, legionella sp., bordetella pertussis, chlamydia, mycoplasma or haemophilus influenzae type B)
Timepoint [3] 253132 0
The outcome of the study will be assessed on a daily basis over the five week period. Time to development of outcome will be measured
Primary outcome [4] 253133 0
Laboratory-confirmed influenza A or B
Timepoint [4] 253133 0
The outcome of the study will be assessed on a daily basis over the five week period. Time to development of outcome will be measured
Primary outcome [5] 253134 0
Adherence with mask or respirator use
Timepoint [5] 253134 0
We will monitor individual participant adherence with mask or respirator use over the four week time course by: (1) Observation: the head ward nurse will observe compliance on the ward on a daily basis and record the information on a structured form, (2) Self report: a diary card with tick boxes will be given to each subject, which they will carry with them during the day. Adherence to wearing the masks or respirators will be monitored by these diary cards and returned to researchers on a weekly basis. Exit interviews with participants will be conducted after the four weeks to gain further insights into adherence and other issues around the use of masks/respirators including adverse effects.
Primary outcome [6] 253295 0
Laboratory confirmed pandemic (H1N1) 2009
Timepoint [6] 253295 0
The outcome of the study will be assessed on a daily basis over the five week period. Time to development of outcome will be measured
Primary outcome [7] 253296 0
Laboratory confirmed virus (any respiratory virus)
Timepoint [7] 253296 0
The outcome of the study will be assessed on a daily basis over the five week period. Time to development of outcome will be measured
Primary outcome [8] 258132 0
Laboratory confirmed bacterial respiratory infection
Timepoint [8] 258132 0
The outcome of the study will be assessed on a daily basis over the five week period. Time to development of outcome will be measured
Secondary outcome [1] 257392 0
The following measure will be used to measure compliance and infection control:
Self report: a diary card with tick boxes for the respirator/mask use will be given to each subject, which they will carry with them during the day. They will tick the responses after each shift. Adherence to wearing the respirator/mask will be monitored by these diary cards that will be returned to researchers on a weekly basis. Time from enrolment to onset of illness will be measured.
Timepoint [1] 257392 0
Participants will be asked to complete their diary card on a daily basis. A member of the research team will assess these cards on a weekly basis.
Secondary outcome [2] 257431 0
The following measure will be used to measure compliance and infection control:
Exit interviews with participants will be conducted after the four weeks to gain further insights into adherence and other issues around the use of respirators/masks including adverse effects. We will specifically ask about pain, discomfort, skin necrosis, difficulty breathing, headaches, adherence to infection control protocol associated with respirator/mask use (hand hygiene, face touching etc) and perceptions about patient communication issues associated with respirator/mask wearing.
Timepoint [2] 257431 0
Interviews with participants will be completed at the end of the four weeks.

Eligibility
Key inclusion criteria
Any nurse, doctor or ward clerk who works full time at the hospital
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Males with beards, long moustaches or long facial hair stubble
2) Clinical staff with a current respiratory illness, rhinitis and/or allergy (Staff who report having a respiratory illness at the time of recruitment will have their participation delayed by two weeks once they have become asymptomatic)
3) Part-time worker

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 unit of randomisation will be hospitals, which will be randomised to one of the three trial arms. Allocation concealment will not be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A secure computerised randomisation program will be used to cluster randomise the hospitals.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2007 0
China
State/province [1] 2007 0

Funding & Sponsors
Funding source category [1] 243600 0
Government body
Name [1] 243600 0
National Health and Medical Research Council - NHMRC
Address [1] 243600 0
GPO Box 1421
Canberra ACT 2601
Country [1] 243600 0
Australia
Primary sponsor type
University
Name
School of Public Health and Community Medicine, University of New South Wales
Address
Samuels Building
The University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 237050 0
Government body
Name [1] 237050 0
Beijing Centre for Disease Control and Surviellance
Address [1] 237050 0
No. 16 He Pingli Middle Street, Dong Cheng District, Beijing, 100013, China
Country [1] 237050 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243728 0
University of New South Wales
Ethics committee address [1] 243728 0
UNSW Research Services
Rupert Myers Building, Level 3
The University of New South Wales NSW 2052
Ethics committee country [1] 243728 0
Australia
Date submitted for ethics approval [1] 243728 0
Approval date [1] 243728 0
20/08/2009
Ethics approval number [1] 243728 0
09225

Summary
Brief summary
A prospective, three-armed cluster randomized trial of respirator/mask use in frontline health care workers (HCWs) to determine the efficacy of two different kinds of respirators/face masks (N95’s, and surgical masks) during the influenza season on the transmission of pandemic H1N1 09, seasonal influenza and other respiratory viruses. Other respiratory viruses such as respiratory syncytial virus (RSV), adenovirus, parainfluenza viruses, coronaviruses, human metapneumovirus (hMPV), rhinoviruses etc are also associated with outbreaks of acute respiratory disease.
Health care workers (HCWs) from the emergency departments, respiratory wards and infectious disease wards of major hospitals in Beijing, China will be recruited. These wards are selected because they are a setting in which repeated and multiple exposures to viral respiratory infections are present for staff. Hospitals will be allocated to one of the three study arms.

Participants will be provided with one of two types of masks/respirators (depending on the arm to which the hospital they work in has been randomised) to be worn for four weeks when working on the ward. All participants will be followed up for five weeks (the four weeks of wearing the masks and an extra week of non-mask wearing)
Trial website
Trial related presentations / publications
MacIntyre C.R, Wang Q, Seale H, Yang P et.al. A randomised clinical trial of three policy options for N95 respirators and medical masks in health workers. (2013) American Journal of Respiratory and Critical Care Medicine. 187 (9), pp. 960-966
Public notes

Contacts
Principal investigator
Name 30146 0
Dr Raina MacIntyre
Address 30146 0
School of Public Health and Community Medicine Level 3,
Samuels Building
The University of New South Wales
Sydney NSW 2052
Country 30146 0
Australia
Phone 30146 0
+61 2 9385 2517
Fax 30146 0
Email 30146 0
r.macintyre@unsw.edu.au
Contact person for public queries
Name 13393 0
Dr Dr Holly Seale
Address 13393 0
School of Public Health and Community Medicine
Level 3, Samuels Building
The University of New South Wales
Sydney NSW 2052
Country 13393 0
Australia
Phone 13393 0
+61 2 9385 3129
Fax 13393 0
+61 2 9313 6185
Email 13393 0
h.seale@unsw.edu.au
Contact person for scientific queries
Name 4321 0
Prof Professor C. Raina MacIntyre
Address 4321 0
School of Public Health and Community Medicine
Level 3, Samuels Building
The University of New South Wales
Sydney NSW 2052
Country 4321 0
Australia
Phone 4321 0
+61 2 9385 2517
Fax 4321 0
+61 2 9313 6185
Email 4321 0
r.macintyre@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary