N/A
N=178
Evaluating Modes of Influenza Transmission Observational Study of Community Acquired Influenza
Influenza Virus Infection Transmission in Humans
Bottom Line
View on ClinicalTrials.gov: NCT01769430 ↗Enrolled (actual)
178
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Viral Copy Number in 30-minute Exhaled Breath Sample — 38,000; 12,000 Fine aerosol RNA copy number
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Observational Study of influenza aerosol shedding -- No Intervention (Other)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of Maryland, College Park
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Copy Number in 30-minute Exhaled Breath Sample |
38,000; 12,000 | — |
| PRIMARY Total Fine Aerosol Infectious Influenza Virus in 30-minute Exhaled Breath Sample |
41 | — |
Summary
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) (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.
Eligibility Criteria
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
-
Data sourced from ClinicalTrials.gov (NCT01769430). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.