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| Sponsor: | University of Michigan |
|---|---|
| Collaborator: |
Centers for Disease Control and Prevention |
| Information provided by: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00490633 |
Purpose
Pharmaceutical interventions, particularly vaccination, have been the principal public health method of preventing and controlling seasonal influenza. Other less invasive non-pharmaceutical interventions include the use of face masks and hand hygiene. In Asia, masks are used extensively, especially in Japan, but with only circumstantial evidence of efficacy. Although there are numerous studies that support hand hygiene as an effective measure for decreasing transmission of enteric infections, there are fewer data assessing the effect of hand hygiene on respiratory illnesses. Therefore it is proposed that a study be conducted on the use of face masks with and without the use of hand hygiene in comparison to no intervention in residence housing units of the University of Michigan. The interventions will be carried out during a period of influenza transmission that is defined by surveillance conducted at the University Health Service. Data will be collected on use of the interventions and the occurrence of influenza and other illnesses. When illness occurs meeting a case definition, specimens for viral isolation will be collected in all intervention settings. Face masks could theoretically lead to a large reduction in transmission frequency of influenza, especially if most transmission occurs by the airborne (large or small droplet) route. Even a modest reduction could have a major effect during an influenza pandemic.
| Condition | Intervention |
|---|---|
|
Influenza |
Behavioral: Ear Loop Procedure Mask Behavioral: 62% Ethyl Alcohol Hand Sanitizer |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Reducing the Transmission of Influenza by Face Masks |
| Enrollment: | 1420 |
| Study Start Date: | October 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Facemask and hand hygiene
Facemask and hand hygiene provided for participants.
|
Behavioral: Ear Loop Procedure Mask
Facemasks were requested to be worn while participants were in the residence hall for year one, and while they were in residence halls for a minimum of six hours per day in year two.
Other Name: TECNOL™ procedure masks, Kimberly-Clark, Roswell GA
Behavioral: 62% Ethyl Alcohol Hand Sanitizer
Hand sanitizer was provided to participants in the facemask and hand hygiene arm for year one and year two of the study.
Other Name: Purell, 62% ethyl alcohol in a gel base
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Experimental: Facemask only
Facemask only provided for participants.
|
Behavioral: Ear Loop Procedure Mask
Facemasks were requested to be worn while participants were in the residence hall for year one, and while they were in residence halls for a minimum of six hours per day in year two.
Other Name: TECNOL™ procedure masks, Kimberly-Clark, Roswell GA
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No Intervention: Control
Control, no intervention.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48104 | |
| Principal Investigator: | Arnold S Monto, MD | University of Michigan |
| Principal Investigator: | Allison E Aiello, PhD | University of Michigan |
More Information
| Responsible Party: | Arnold S. Monto, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00490633 History of Changes |
| Other Study ID Numbers: | HUM00008566 |
| Study First Received: | June 21, 2007 |
| Last Updated: | August 18, 2011 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
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Influenza Non Pharmaceutical Intervention Face Mask Hand Hygiene |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Ethanol |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |