- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01769430
Evaluating Modes of Influenza Transmission Observational Study of Community Acquired Influenza (EMIT)
Evaluating Modes of Influenza Transmission Work Package 1: Observational Study of Community Acquired Influenza
Study Overview
Status
Detailed Description
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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College Park, Maryland, United States, 20742
- University of Maryland School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Community acquired respiratory infection
Measurement of exhaled breath aerosol
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Viral copy number in exhaled breath aerosol coarse and fine particle fractions
Time Frame: At enrollment and over 2 days follow-up
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Participants will sit for 30 minutes with their face inside the cone/funnel of the Gesundheit-II (G-II)human bioaerosol collector (McDevitt JJ et al.
Aerosol Sci Technol 2013, in press).
Subjects are free to tidal breathe, cough, and talking.
A conventional slit impactor collects particles > 5.0 μm.
Condensation of water vapor is used to grow remaining particles for efficient collection by a 1.0 μm slit impactor and be deposited into a buffer-containing collector.
Samples are assayed by RT-PCR and viral culture.
The method was previously used to assess effectiveness of surgical masks for containing influenza virus aerosols (Milton DK, et al.
PLoS Pathogens 2013, in press).
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At enrollment and over 2 days follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of exhaled particle counts and viral copy numbers
Time Frame: At enrollment and over 2 days follow-up
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Hypothesis: exhaled particle numbers counted with an optical particle counter (Exhalair, Pulmatrix, Inc, Lexington, MA) during tidal breathing will correlate with exhaled viral copy numbers, especially in the fine particle fraction
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At enrollment and over 2 days follow-up
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Impact of multiple infection
Time Frame: At enrollment and over 2 days of follow-up
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Hypothesis: co-infection with other respiratory agents will increase aerosol production
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At enrollment and over 2 days of follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Correlation of exhaled virus in community acquired and experimental infection
Time Frame: At enrollment and up to 2 days of follow-up
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These data will be used to compare subjects with community acquired influenza with donor subjects artificially infected with influenza in EMIT-Work Package 3 and with recipient subjects exposed the the donors.
We will test the hypothesis that the donor subjects in EMIT-WP3 produce similar amounts of viral aerosol as do community acquired infection cases.
We will also examine whether recipients exposed only to aerosols differ from those exposed by contact and large droplet as well as aerosol routes with respect to exhaled aerosol virus.
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At enrollment and up to 2 days of follow-up
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RSV and other respiratory infections
Time Frame: At enrollment
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Hypothesis: RSV and cases with other respiratory infections who are not infected with influenza will have the infecting agent present in exhaled breath aerosols
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At enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Donald K Milton, MD, DrPH, University of Maryland
Publications and helpful links
General Publications
- Fabian P, McDevitt JJ, DeHaan WH, Fung RO, Cowling BJ, Chan KH, Leung GM, Milton DK. Influenza virus in human exhaled breath: an observational study. PLoS One. 2008 Jul 16;3(7):e2691. doi: 10.1371/journal.pone.0002691.
- Milton DK, Fabian MP, Cowling BJ, Grantham ML, McDevitt JJ. Influenza virus aerosols in human exhaled breath: particle size, culturability, and effect of surgical masks. PLoS Pathog. 2013 Mar;9(3):e1003205. doi: 10.1371/journal.ppat.1003205. Epub 2013 Mar 7.
- McDevitt JJ, Koutrakis P, Ferguson ST, Wolfson JM, Fabian MP, Martins M, Pantelic J, Milton DK. Development and Performance Evaluation of an Exhaled-Breath Bioaerosol Collector for Influenza Virus. Aerosol Sci Technol. 2013 Jan 1;47(4):444-451. doi: 10.1080/02786826.2012.762973. Epub 2013 Jan 25.
- Yan J, Grantham M, Pantelic J, Bueno de Mesquita PJ, Albert B, Liu F, Ehrman S, Milton DK; EMIT Consortium. Infectious virus in exhaled breath of symptomatic seasonal influenza cases from a college community. Proc Natl Acad Sci U S A. 2018 Jan 30;115(5):1081-1086. doi: 10.1073/pnas.1716561115. Epub 2018 Jan 18.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 017086-001
- 1U01IP000497 (NIH)
- 3U01CI000446 (NIH)
- RC1AI086900 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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