CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 178 enrolled
Drug / intervention
Observational Study of influenza aerosol shedding -- No Interventionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01769430
NCT01769430N/ACompleted

Evaluating Modes of Influenza Transmission Work Package 1: Observational Study of Community Acquired Influenza

University of Maryland, College Park·observational·Posted Jan 16, 2013·Updated Apr 25, 2025

In Brief

An observational study evaluating Observational Study of influenza aerosol shedding -- No Intervention for Influenza Virus Infection Transmission in Humans. Completed, enrolled 178 participants across 1 site.

Detailed 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 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2013
Enrollment StartDec 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.5 years ago

Interventions

Observational Study of influenza aerosol shedding -- No Interventionother

No intervention -- observational study only