Evaluating Modes of Influenza Transmission Observational Study of Community Acquired Influenza
Status: | Completed |
---|---|
Conditions: | Influenza, Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 10 - Any |
Updated: | 4/17/2018 |
Start Date: | December 2012 |
End Date: | March 2013 |
Evaluating Modes of Influenza Transmission Work Package 1: Observational Study of Community Acquired Influenza
The recent swine origin influenza pandemic (2009), new emergence of swine origin H3N2v, and
delayed availability of vaccine for these agents highlight the need to test and optimize
public health intervention strategies to reduce transmission of influenza. We will use a new
technology for biological particle collection (U.S. Provisional Patent Application No.
61/162,395, McDevitt et al., Aerosol Sci Technol 2013) to make fundamental observations on
infectious respiratory droplets in a study of up to 200 naturally occurring seasonal
influenza cases. We will collect respiratory droplets shed by participants while breathing
normally, talking, and spontaneously coughing. We will characterize the size distribution of
droplets containing infectious virus. We will use these basic data to examine the roles of
large and small respiratory droplets and examine how the interaction of host factors and
virus type impact the shedding of infectious respiratory droplets. Subjects will be recruited
through a web based respiratory illness surveillance system, health clinics and advertisement
in the campus community. Sitting in the collection booth will not create additional
discomfort or risk for volunteers already suffering from influenza infection. We will recruit
up to 1000 persons with symptoms of acute respiratory illness for screening with collection
of nasopharyngeal swabs and questionnaire. From among those screened, we will recruit 250 to
give exhaled breath samples, and ask 50 people with influenza to return for follow up exhaled
breath samples on up to two subsequent days. We hypothesize that (1) fine aerosols (<5
microns in aerodynamic diameter) will contain more viral copies than coarse aerosol particles
(>= 5 microns) (2) fine aerosols will contain culturable virus indicating that the fine
aerosols are infectious, (3) aerosol shedding will correlate with virus load measured by
swabs, (4) presence of active cough during sampling will be associated with increased aerosol
shedding, (5) clinical symptoms and signs, including fever can be used to predict viral
aerosol shedding.
delayed availability of vaccine for these agents highlight the need to test and optimize
public health intervention strategies to reduce transmission of influenza. We will use a new
technology for biological particle collection (U.S. Provisional Patent Application No.
61/162,395, McDevitt et al., Aerosol Sci Technol 2013) to make fundamental observations on
infectious respiratory droplets in a study of up to 200 naturally occurring seasonal
influenza cases. We will collect respiratory droplets shed by participants while breathing
normally, talking, and spontaneously coughing. We will characterize the size distribution of
droplets containing infectious virus. We will use these basic data to examine the roles of
large and small respiratory droplets and examine how the interaction of host factors and
virus type impact the shedding of infectious respiratory droplets. Subjects will be recruited
through a web based respiratory illness surveillance system, health clinics and advertisement
in the campus community. Sitting in the collection booth will not create additional
discomfort or risk for volunteers already suffering from influenza infection. We will recruit
up to 1000 persons with symptoms of acute respiratory illness for screening with collection
of nasopharyngeal swabs and questionnaire. From among those screened, we will recruit 250 to
give exhaled breath samples, and ask 50 people with influenza to return for follow up exhaled
breath samples on up to two subsequent days. We hypothesize that (1) fine aerosols (<5
microns in aerodynamic diameter) will contain more viral copies than coarse aerosol particles
(>= 5 microns) (2) fine aerosols will contain culturable virus indicating that the fine
aerosols are infectious, (3) aerosol shedding will correlate with virus load measured by
swabs, (4) presence of active cough during sampling will be associated with increased aerosol
shedding, (5) clinical symptoms and signs, including fever can be used to predict viral
aerosol shedding.
This study is a follow-on to earlier projects funded by the US Centers for Disease Control
and Prevention (CDC) and the National Institute for Allergy and Infectious Diseases (NIAID)
that developed the sampler and studied the impact of surgical masks on reducing viral aerosol
release by persons infected with influenza virus. The funding organizations have no direct
control over the study design, execution, or reporting and no access to identifiable human
data. The CDC IRB has determined that the CDC is not engaged in human subjects research in
this cooperative agreement.
Hypotheses:
- Fine particle aerosols will contain greater numbers of viral copies than will coarse
aerosol particles.
- Clinical symptoms and signs, including fever can be used to predict viral aerosol
shedding
- Fine aerosols will contain culturable virus indicating that the fine aerosols are
infectious
- Aerosol shedding will correlate with virus load measured by nasopharyngeal and throat
swabs
- Presence of active cough during sampling will be associated with increased aerosol
shedding with a stronger correlation to be found with coarse than fine particle virus
aerosols
and Prevention (CDC) and the National Institute for Allergy and Infectious Diseases (NIAID)
that developed the sampler and studied the impact of surgical masks on reducing viral aerosol
release by persons infected with influenza virus. The funding organizations have no direct
control over the study design, execution, or reporting and no access to identifiable human
data. The CDC IRB has determined that the CDC is not engaged in human subjects research in
this cooperative agreement.
Hypotheses:
- Fine particle aerosols will contain greater numbers of viral copies than will coarse
aerosol particles.
- Clinical symptoms and signs, including fever can be used to predict viral aerosol
shedding
- Fine aerosols will contain culturable virus indicating that the fine aerosols are
infectious
- Aerosol shedding will correlate with virus load measured by nasopharyngeal and throat
swabs
- Presence of active cough during sampling will be associated with increased aerosol
shedding with a stronger correlation to be found with coarse than fine particle virus
aerosols
Inclusion Criteria:
- Presence of symptomatic respiratory infection or other evidence of respiratory
infection:
- During the influenza season, subjects will be enrolled if they have
- influenza-like illness (symptoms of fever and either cough or sore throat)
and either
- a positive point of care rapid test for influenza infection or
- objectively documented fever in the setting of a documented local influenza
outbreak (presence of rapid test or PCR confirmed cases).
- Onset within the previous 48 hours
- Prior to onset of influenza season and if we have not achieved enrollment of our
target population by the end of flu season, we will enroll subjects with cough,
coryza (stuffy runny nose, sore throat, sneezing), and malaise (fatigue)
characteristic of the 'common cold' often resulting from Human Rhinovirus, RSV,
parainfluenza, and to some extent influenza virus.
Exclusion Criteria:
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