Intervention Study of Face Mask and Hand Sanitizer to Reduce Influenza Transmission (M-FLU)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00490633
First received: June 21, 2007
Last updated: August 18, 2011
Last verified: June 2007
  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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Number of laboratory confirmed cases of Influenza [ Time Frame: 8 weeks, including the 6 weeks of intervention and two weeks post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of cases of Influenza Like Illness [ Time Frame: 6 weeks of intervention ] [ Designated as safety issue: No ]

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
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
No Intervention: Control
Control, no intervention.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 29, 2014