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Intervention Study of Face Mask and Hand Sanitizer to Reduce Influenza Transmission (M-FLU)
This study is ongoing, but not recruiting participants.
First Received: June 21, 2007   Last Updated: June 22, 2007   History of Changes
Sponsors and Collaborators: University of Michigan
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

MedlinePlus related topics: Flu
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Uncontrolled, Factorial Assignment, Efficacy Study
Official Title: Reducing the Transmission of Influenza by Face Masks

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Number of laboratory confirmed cases of Inlfuenza [ Time Frame: 8 weeks, including the 6 weeks of intervention and two weeks post-intervention ]

Secondary Outcome Measures:
  • Number of cases of Influenza Like Illness [ Time Frame: 6 weeks of intervention ]

Enrollment: 1420
Study Start Date: October 2006
Estimated Study Completion Date: April 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Residence in selected University of Michigan Residence Halls

Exclusion Criteria:

  • Non-residence in selected Residence Halls
  • Unwillingness to utilize face mask and hand sanitizer and complete online surveys
  • Already study employee
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490633

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Arnold S Monto, MD University of Michigan
Principal Investigator: Allison E Aiello, PhD University of Michigan
  More Information

Additional Information:
No publications provided

Study ID Numbers: HUM00008566
Study First Received: June 21, 2007
Last Updated: June 22, 2007
ClinicalTrials.gov Identifier: NCT00490633     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Federal Government

Keywords provided by University of Michigan:
Influenza
Non Pharmaceutical Intervention
Face Mask
Hand Hygiene

Study placed in the following topic categories:
Virus Diseases
Anti-Infective Agents, Local
Respiratory Tract Diseases
Respiratory Tract Infections
Facies
Influenza, Human
Central Nervous System Depressants
Orthomyxoviridae Infections
Ethanol

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Physiological Effects of Drugs
Central Nervous System Depressants
Orthomyxoviridae Infections
Pharmacologic Actions
Virus Diseases
Anti-Infective Agents, Local
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Influenza, Human
Central Nervous System Agents
Ethanol

ClinicalTrials.gov processed this record on May 07, 2009