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NCT01769430 · ClinicalTrials.gov registry record

Evaluating Modes of Influenza Transmission Observational Study of Community Acquired Influenza

A clinical trial, sponsored by University of Maryland, College Park.

Completed
Registry status
178
Enrollment target

NCT01769430: Completed study, sponsored by University of Maryland, College Park.

NCT01769430 is a clinical trial that has completed, run by University of Maryland, College Park. The registered enrollment target is 178 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01769430 has completed, sponsored by University of Maryland, College Park.

COMPLETED
Registry status
178 participants
Enrollment target

Study 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

Primary Outcome

Total viral RNA copies detected in breath aerosol exhaled during a 30-minute sample collection. Participants sit for 30 minutes with face inside the cone/funnel of the Gesundheit-II (G-II) human bioaerosol collector (https://doi.org/10.1080/02786826.2012.762973) collecting air at 130 L/min. Particles in air are concentrated into a small volume of buffer. The copies per mL of buffer is measured by PCR and corrected to the total amount collected per 30-min sample. See publication in the Proceeding

Interventions

  • OTHER Observational Study of influenza aerosol shedding -- No Intervention

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2012-12
Est. Completion 2013-03

What the finished NCT01769430 record still lists

NCT01769430 is an observational study that tracks outcomes without assigning an intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Observational Study of influenza aerosol shedding -- No Intervention is the first listed.

NCT01769430 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01769430 about?

NCT01769430 is a clinical study titled "Evaluating Modes of Influenza Transmission 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 ...

What is the current status of trial NCT01769430?

This trial is currently completed. The enrollment target is 178 participants. The study started on 2012-12. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01769430?

The interventions under investigation include: Observational Study of influenza aerosol shedding -- No Intervention (OTHER).

Who is sponsoring clinical trial NCT01769430?

This trial is sponsored by University of Maryland, College Park, which has 46 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01769430, the US trial registry maintained by the National Library of Medicine. NCT01769430 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.