Trial Review

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
ACTRN12607000183482
Ethics application status
Approved
Date submitted
20/03/2007
Date registered
27/03/2007
Date last updated
29/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A cluster-randomised study of mask use in control of influenza or other respiratory virus transmission within the family with at least two adults and only one ill child
Scientific title
A cluster-randomised study of mask use in control of influenza or other respiratory virus transmission within the family with at least two adults and only one ill child.
Secondary ID [1] 288861 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Control of influenza or other respiratory virus transmission. 1701 0
Condition category
Condition code
Infection 298325 298325 0 0
Other infectious diseases
Respiratory 298326 298326 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Families will be divided into three groups for the study. Group one and two are the intrevention groups and group three is the control group.
Group 1: adults in the family will receive surgical masks for use while in the same room as the sick child.
Group 2: adults in the family will wear P2 masks while in the same room as the sick child.
The P2 masks , is a facial mask which protects against airborne micro-organisms.
Intervention code [1] 1661 0
Prevention
Comparator / control treatment
Group 3: will not receive masks.
Groups one and two willl wear the masks daily for one week or until a contact develops a influenza like illness.
Control group
Active

Outcomes
Primary outcome [1] 2513 0
Influneza like illness and laboratory diagnosis of influenza or other respiratory viruses, determined from a nose and/or throat swab.
Timepoint [1] 2513 0
Within one week of enrolment
Secondary outcome [1] 4327 0
Impact on influenza transmission within the household.
Timepoint [1] 4327 0
At baseline and one week post enrolment

Eligibility
Key inclusion criteria
1) The child is the first and only person ill in the family and 2) The child lives with at least two adults at home.3) The childs aged between 0 to 15 years4) The adults can be anyone over the age of 16 years.
Minimum age
0 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability or refusal to consent 2) Child’s admission to hospital3) Residing in household with less than two adults 4) Other family members who have been ill in the 2 weeks prior to or simultaneous to the child.

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)
central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2007
Actual
9/10/2006
Date of last participant enrolment
Anticipated
Actual
30/08/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
286
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1945 0
Government body
Name [1] 1945 0
National Health and Medical Research Council
Country [1] 1945 0
Australia
Primary sponsor type
Government body
Name
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
Address
Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St
Westmead NSW 2145, Australia
Country
Australia
Secondary sponsor category [1] 1758 0
Individual
Name [1] 1758 0
Doctor Dominic Dwyer,
Address [1] 1758 0
Institute for Clinical Pathology and Medical Research (ICPMR)
Cnr Darcy Rd & Bridge St,
Westmead Hospital
Westmead NSW 2145
Country [1] 1758 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3623 0
Children's Hospital at Westmead
Ethics committee address [1] 3623 0
Westmead, NSW
Ethics committee country [1] 3623 0
Australia
Date submitted for ethics approval [1] 3623 0
Approval date [1] 3623 0
01/09/2006
Ethics approval number [1] 3623 0
2006/058

Summary
Brief summary
This study is a prospective, 3-armed cluster-randomised trial to determine the effect of the use of two different kinds of face masks on the transmission of influenza and other respiratory viruses. The starting point will be patients with influenza-like illness (ILI), whose households will then become the focus of the study. Index cases with ILI will be identified using the emergency department of the Children's Hospital at Westmead and their families will be approached to give their consent. In two arms of the study, adult contacts in the household will be provided with one of two types of face mask (surgical masks or P2 masks) to be worn when in the same room as the index case. Families in the third arm of the study will receive only education about infection control. Several measures will be used to measure compliance, including observation by family members within the household, self report through the use of diary cards, and interviews with a random selection of participants. There will be two main outcomes: ILI and laboratory diagnosis of influenza or other respiratory viruses (as determined from nasopharyngeal swabs and blood samples), and impact on influenza transmission within the household.
Trial website
Trial related presentations / publications
Maclntyre, C.R., Cauchemez, S., Dwyer, D.E., Seale, H., Cheung, P., Browne, G., Fasher, M., Wood, J., Gao, Z., Booy, R., Ferguson, N. Face mask use and control of respiratory virus transmission in households. (2009) Emerging Infectious Diseases, 15 (2), pp. 233-241
Public notes

Contacts
Principal investigator
Name 27764 0
Prof Raina MacIntyre
Address 27764 0
School of Public Health and Community Medicine
University of New South Wales
Level 3, Samuels Building
Gate 11, Botany St, Randwick, NSW, 2031
Country 27764 0
Australia
Phone 27764 0
+61 02 9385 3811
Fax 27764 0
Email 27764 0
[email protected]
Contact person for public queries
Name 10850 0
Dr Holly Seale
Address 10850 0
School of Public Health and Community Medicine
University of New South Wales
Level 3, Samuels Building
Gate 11, Botany St, Randwick, NSW, 2031
Country 10850 0
Australia
Phone 10850 0
+61 02 9385 3129
Fax 10850 0
+61 02 9313 6185
Email 10850 0
[email protected]
Contact person for scientific queries
Name 1778 0
Prof Prof Raina MacIntryre
Address 1778 0
School of Public Health and Community Medicine
University of New South Wales
Level 3, Samuels Building
Gate 11, Botany St, Randwick, NSW, 2031
Country 1778 0
Australia
Phone 1778 0
+61 02 9385 3811
Fax 1778 0
+61 02 9313 6185
Email 1778 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
No additional documents have been identified.