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Trial registered on ANZCTR


Registration number
ACTRN12613000852752
Ethics application status
Approved
Date submitted
26/07/2013
Date registered
2/08/2013
Date last updated
12/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effectiveness of mask use as source infection control for people with influenza-like-illness in Beijing, China
Scientific title
Randomised control trial of the effectiveness of mask use as source infection control for people with influenza-like-illness
Secondary ID [1] 282897 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Viral or bacterial respiratory infections 289714 0
Condition category
Condition code
Infection 290036 290036 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The index case will be randomised into one of two arms:
1. Intervention arm – the index case will wear a surgical mask at home

2. Control arm – the index case will not receive any intervention.

Participants from group one will be asked to wear a mask whenever they are in the same room as a family member or visitor to the household. They will be informed that they can remove their masks during meal times and while asleep. They will be shown how to wear the mask and informed to wash their hands when donning and removing the mask.

Participants will be provided with three masks per day for 7 days (21 masks in total). They will be informed that they can cease wearing a mask once their symptoms resolve.

Mask use by other family members is not required.

Participants will be asked to complete a diary card for seven 7 which will record their mask use, their contact with family members etc.

Exit interviews will be conducted with all participants to examine standard practices around mask use, issues affecting compliance and attitudes towards mask/respirator use.
Intervention code [1] 287597 0
Prevention
Comparator / control treatment
Participants will continue with their normal practices and will not be given any masks
Control group
Active

Outcomes
Primary outcome [1] 290084 0
Clinical respiratory illness (CRI), defined as two or more respiratory symptoms or one respiratory symptom and a systemic symptom.

The outcomes will be measured in family members of the primary participant (index case). Time to development of outcome will be measured.

Respiratory and systemic symptoms will be documented for both the index cases and the all unwell family members over the seven day period.
Timepoint [1] 290084 0
Participants will be actively followed up for seven days following recruitment, for the development of illness amongst household members.
Primary outcome [2] 290085 0
Influenza-like illness (ILI), defined as fever equal to or greater than 38 degrees C plus one respiratory symptom.

The outcomes will be measured in family members of the primary participant (index case). Time to development of outcome will be measured.

Respiratory and systemic symptoms will be documented for both the index cases and the all unwell family members over the seven day period.
Timepoint [2] 290085 0
Participants will be actively followed up for seven days following recruitment, for the development of illness amongst household members.
Primary outcome [3] 290094 0
Laboratory-confirmed viral or bacterial respiratory infection:

Viral- adenoviruses, human metapneumovirus, coronaviruses 229E/NL63 and OC43/HKU1, parainfluenzaviruses 1, 2 and 3, influenza viruses A and B, respiratory syncytial virus A and B, or rhinovirus A/B

Bacterial- Streptococcus pneumoniae, legionella, Bordetella pertussis, chlamydia, Mycoplasma pneumoniae or Haemophilus influenzae type B

The outcomes will be measured in family members of the primary participant (index case). Time to development of outcome will be measured.

Specimens will be collected from index cases and symptomatic family members and tested via multiplex PCR. Double rayon-tipped, plastic-shafted swabs will be used to scratch both the tonsilar areas and the posterior pharyngeal wall of symptomatic subjects.
Timepoint [3] 290094 0
Participants will be actively followed up for seven days following recruitment, for the development of illness amongst household members.
Secondary outcome [1] 303917 0
Laboratory confirmed virus (adenoviruses, human metapneumovirus, coronaviruses 229E/NL63 and OC43/HKU1, parainfluenzaviruses 1, 2 and 3, influenza viruses A and B, respiratory syncytial virus A and B, or rhinovirus A/B)

The outcomes will be measured in family members of the primary participant (index case). Time to development of outcome will be measured.

Specimens will be collected from index cases and symptomatic family members and tested via multiplex PCR. Double rayon-tipped, plastic-shafted swabs will be used to scratch both the tonsilar areas and the posterior pharyngeal wall of symptomatic subjects.
Timepoint [1] 303917 0
Participants will be actively followed up for seven days following recruitment, for the development of illness amongst household members.
Secondary outcome [2] 303924 0
Laboratory-confirmed influenza A or B

The outcomes will be measured in family members of the primary participant (index case). Time to development of outcome will be measured.

Specimens will be collected from index cases and symptomatic family members and tested via multiplex PCR. Double rayon-tipped, plastic-shafted swabs will be used to scratch both the tonsilar areas and the posterior pharyngeal wall of symptomatic subjects.
Timepoint [2] 303924 0
Participants will be actively followed up for seven days following recruitment, for the development of illness amongst household members.
Secondary outcome [3] 303925 0
Laboratory confirmed bacterial respiratory infection (Streptococcus pneumoniae, legionella, Bordetella pertussis, chlamydia, Mycoplasma pneumoniae or Haemophilus influenzae type B )

The outcomes will be measured in family members of the primary participant (index case). Time to development of outcome will be measured.

Specimens will be collected from index cases and symptomatic family members and tested via multiplex PCR. Double rayon-tipped, plastic-shafted swabs will be used to scratch both the tonsilar areas and the posterior pharyngeal wall of symptomatic subjects.
Timepoint [3] 303925 0
Participants will be actively followed up for seven days following recruitment, for the development of illness amongst household members.
Secondary outcome [4] 303926 0
Compliance with mask use (for participants in group 1)
Timepoint [4] 303926 0
A diary card with tick boxes for the mask use will be given to each subject. They will tick the responses after each day for seven day.

Eligibility
Key inclusion criteria
The index case must:
1. Be the only person in the household to currently have an influenza-like-illness and there should be no history of influenza-like-illness amongst family members in the last 14 days.

2. Live with at least two other people at home

3. Be a permanent resident in Beijing

4. Be able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability or refusal to consent

2. Symptom onset >24 hours prior to recruitment

3. Admission to hospital

4. Residing in household with less than two people

5. Other family members who have been influenza-like-illness in the two weeks prior to or simultaneous to the index patient.

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)
Adults who attend a fever clinic in Beijing China, will be screened by hospital staff to identify if they are eligible for the study. If eligible, a study staff member will approach each patient while they are in attendance at the clinic and invite them to participate about the study. Informed consent will be collected from the patient prior to randomisation. Recruitment will be carried out over a period of 6 weeks.

Due to the nature of the intervention, it is not feasible to conceal allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program will be used to generate the sequence in which the subjects will be randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome of interest will be the efficacy of patient mask use on preventing infection outcomes in household contacts.

The attack rates and incidence rate of infection in households will also be an outcome.

An intention to treat analysis will be performed to look at the impact of masks on attack rate and incidence rate. Intention to treat analysis will also be done to determine the efficacy of masks as patient source control in preventing clinical respiratory illness in family members.

Arms will be compared for socio-demographic characteristics, and if any imbalance in randomisation is suggested, unevenly distributed variables will be adjusted for by multivariate logistic regression.

Levels of compliance will be quantified, and correlated to levels of respiratory virus transmission. Attack rates and incidence rates of respiratory virus infections will be quantified. Relative risks will be calculated for masks.

Assuming the attack rate of clinical respiratory infection (CRI) in the control families is 16-20%, with 5% significance level and 85% power, if we want to see a minimum relative risk of 0.5 (intervention/control), we will need 385 participants in each group which is composed of 118 families and on average, 3 members per family. An estimated 250 patients with ILI will be recruited into the study to allow for possible patient fall out through the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/11/2013
Actual
18/11/2013
Date of last participant enrolment
Anticipated
9/12/2013
Actual
24/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment outside Australia
Country [1] 5245 0
China
State/province [1] 5245 0
Beijing

Funding & Sponsors
Funding source category [1] 287678 0
University
Name [1] 287678 0
University of New South Wales
Country [1] 287678 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
University of New South Wales
Gate 9, High St
Randwick, NSW 2052
Country
Australia
Secondary sponsor category [1] 286413 0
Government body
Name [1] 286413 0
Beijing Centers for Disease Control and Prevention
Address [1] 286413 0
No.16 He Pingli Middle Street
Dong Cheng District,
Beijing, 100013,
Country [1] 286413 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289642 0
Human Research Ethics Committee (University of New South Wales)
Ethics committee address [1] 289642 0
Ethics committee country [1] 289642 0
Australia
Date submitted for ethics approval [1] 289642 0
06/08/2013
Approval date [1] 289642 0
10/09/2013
Ethics approval number [1] 289642 0
HC13236
Ethics committee name [2] 290154 0
Beijing Center for Disease Prevention and Control IRB
Ethics committee address [2] 290154 0
Ethics committee country [2] 290154 0
China
Date submitted for ethics approval [2] 290154 0
Approval date [2] 290154 0
16/08/2013
Ethics approval number [2] 290154 0

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

Contacts
Principal investigator
Name 41718 0
Prof Raina MacIntyre
Address 41718 0
School of Public Health and Community Medicine
Level 3, Samuels Building, University of New South Wales
Botany St
Randwick, NSW 2052
Country 41718 0
Australia
Phone 41718 0
+61 2 9385 3811
Fax 41718 0
+61 2 9313 6185
Email 41718 0
r.macintyre@unsw.edu.au
Contact person for public queries
Name 41719 0
Holly Seale
Address 41719 0
School of Public Health and Community Medicine
Level 2, Samuels Building, University of New South Wales
Botany St
Randwick, NSW 2052
Country 41719 0
Australia
Phone 41719 0
+61 2 9385 3129
Fax 41719 0
+61 2 9313 6185
Email 41719 0
h.seale@unsw.edu.au
Contact person for scientific queries
Name 41720 0
Raina MacIntyre
Address 41720 0
School of Public Health and Community Medicine
Level 3, Samuels Building, University of New South Wales
Botany St
Randwick, NSW 2052
Country 41720 0
Australia
Phone 41720 0
+61 2 9385 3811
Fax 41720 0
+61 2 9313 6185
Email 41720 0
r.macintyre@unsw.edu.au

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
Dimensions AICluster randomised controlled trial to examine medical mask use as source control for people with respiratory illness2016https://doi.org/10.1136/bmjopen-2016-012330
N.B. These documents automatically identified may not have been verified by the study sponsor.