Intervention Study of Face Mask and Hand Sanitizer to Reduce Influenza Transmission

NCT00490633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1420

Last updated 2011-08-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Arnold S Monto, MD · University of Michigan

  • Allison E Aiello, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00490633 on ClinicalTrials.gov