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

This study has been completed.
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00425893
First received: January 19, 2007
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention
Influenza
 Behavioral: hand hygiene
Other: health education
Device: face masks

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised Controlled Trial of Face Masks and Hand Hygiene in Reducing Influenza Transmission in Households

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • secondary influenza infection [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 6069
Study Start Date: February 2007
Study Completion Date: November 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
health education
 Other: health education
Proper nutrition, etc.
Experimental: 2
hand hygiene
 Behavioral: hand hygiene
alcohol-based hand wash
Experimental: 3
masks and hand hygiene
 Behavioral: hand hygiene
alcohol-based hand wash
Device: face masks
face masks

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Member of family with influenza infected member

Exclusion Criteria:

  • Age less than 2 yr
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425893

Locations
China, Hong Kong
University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Centers for Disease Control and Prevention
The University of Hong Kong
Investigators
Principal Investigator: Benjamin J Cowling, PhD The University of Hong Kong
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peter Houck, MD, CDC
ClinicalTrials.gov Identifier: NCT00425893     History of Changes
Other Study ID Numbers: CDC-NCCID-UCI000439A, CDC Grant# 1 U01 CI000439-01
Study First Received: January 19, 2007
Last Updated: April 12, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
influenza
masks
transmission
hand hygiene
non-pharmacologic interventions

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013