- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00425893
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households
April 12, 2012 updated by: Centers for Disease Control and Prevention
This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Randomised controlled trial of surgical masks and alcohol hand wash among approximately 6069 Hong Kong residents who have a household member diagnosed with influenza.
Influenza in index member and secondary infection will be documented with rapid influenza tests and PCR.
Minimal risk to participants.
Study Type
Interventional
Enrollment (Actual)
6069
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hong Kong
-
Hong Kong, Hong Kong, China
- University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Member of family with influenza infected member
Exclusion Criteria:
- Age less than 2 yr
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
health education
|
Proper nutrition, etc.
|
|
Experimental: 2
hand hygiene
|
alcohol-based hand wash
|
|
Experimental: 3
masks and hand hygiene
|
alcohol-based hand wash
face masks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
secondary influenza infection
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cowling BJ, Chan KH, Fang VJ, Cheng CK, Fung RO, Wai W, Sin J, Seto WH, Yung R, Chu DW, Chiu BC, Lee PW, Chiu MC, Lee HC, Uyeki TM, Houck PM, Peiris JS, Leung GM. Facemasks and hand hygiene to prevent influenza transmission in households: a cluster randomized trial. Ann Intern Med. 2009 Oct 6;151(7):437-46. doi: 10.7326/0003-4819-151-7-200910060-00142. Epub 2009 Aug 3.
- Cowling BJ, Fung RO, Cheng CK, Fang VJ, Chan KH, Seto WH, Yung R, Chiu B, Lee P, Uyeki TM, Houck PM, Peiris JS, Leung GM. Preliminary findings of a randomized trial of non-pharmaceutical interventions to prevent influenza transmission in households. PLoS One. 2008 May 7;3(5):e2101. doi: 10.1371/journal.pone.0002101.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
January 19, 2007
First Submitted That Met QC Criteria
January 22, 2007
First Posted (Estimate)
January 23, 2007
Study Record Updates
Last Update Posted (Estimate)
April 13, 2012
Last Update Submitted That Met QC Criteria
April 12, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCCID-UCI000439A
- CDC Grant# 1 U01 CI000439-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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