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NCT00425893 Clinical Trial

A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households

Influenza Clinical Trial

Official title:
A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00425893
Other study ID # CDC-NCCID-UCI000439A
Secondary ID CDC Grant# 1 U01
Status Completed
Phase N/A
First received January 19, 2007
Last updated April 12, 2012
Start date February 2007
Est. completion date November 2008

Study information
Verified date April 2012
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Joint CUHK-NTEC Clinical Research Ethics CommitteeUnited States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will test the effectiveness of face masks and hand cleaning in preventing the spread of influenza within households

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.

Recruitment information / eligibility
Status Completed
Enrollment 6069
Est. completion date November 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Member of family with influenza infected member

Exclusion Criteria:

- Age less than 2 yr

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• hand hygiene
alcohol-based hand wash
Other:
• health education
Proper nutrition, etc.
Device:
• face masks
face masks

Locations
Country Name City State
China University of Hong Kong Hong Kong Hong Kong

Sponsors (2)
Lead Sponsor Collaborator
Centers for Disease Control and Prevention The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary secondary influenza infection 7 days No
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