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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03491020
Other study ID # IRB00038054
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 2024
Est. completion date May 2025

Study information

Verified date July 2023
Source Wake Forest University Health Sciences
Contact Werner Bischoff, MD
Phone 336-716-5116
Email wbischof@wakehealth.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Airborne transmission represents one of the most rapidly spreading and dangerous dissemination mechanisms for pathogens. Public health strategies to prevent and control the often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment, if available, 2) isolation and barrier precautions such as face masks, and 3) decontamination of the exposed areas and surfaces. A lack of understanding how these pathogens are transmitted hampers the ability to develop effective prevention measures. This study will be used to collect preliminary data of the emission patterns of respiratory pathogens.


Description:

Airborne transmission represents one of the most rapidly spreading and dangerous dissemination mechanisms for pathogens. The study team have been investigating bacterial and viral transmission routes and barrier precautions. In a recent clinical study, it was observed that Measles virus RNA was detected from a patient for at least up to 10 feet. In addition, the group has been studying barrier precautions (facemasks) for their ability to prevent the spread of aerosolized viruses. Finally, in a controlled lab setting the investigators have assessed the impact of environmental conditions (temperature, humidity) on pathogen transmission and the effect of UV-C light to prevent the spread of influenza. The purpose of this observational study is to describe the human aerosolization patterns of respiratory pathogens. The study team hypothesizes that the emission patterns of specific airborne pathogens varies between individual patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 55
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients >18 years of age admitted to the ED or an inpatient care unit of Wake Forest Baptist Medical Center (WFBMC) - Positive Exclusion Criteria: - positive respiratory pathogen tests

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary particle size distribution patterns: ICU This outcome measure will determine the particle size distribution patterns of the pathogen in the intensive care unit (ICU). throughout study completion, up to 7 days
Primary particle size distribution patterns: non-ICU setting This outcome measure will determine the particle size distribution patterns of the pathogen in the non-intensive care unit (ICU). throughout study completion, up to 7 days
Primary quantities of the pathogen: ICU This outcome measure will determine the quantities of the pathogen in the intensive care unit (ICU). throughout study completion, up to 7 days
Primary quantities of the pathogen: non-ICU setting This outcome measure will determine the quantities of the pathogen in the non-intensive care unit (ICU). throughout study completion, up to 7 days
Primary spatial model: ICU This outcome measure will establish a spatial model (1 foot vs. 3- feet vs. 8-10 feet) of airborne pathogen dispersal in the ICU. throughout study completion, up to 7 days
Primary spatial model: non-ICU setting This outcome measure will establish a spatial model (1 foot vs. 3- feet vs. 8-10 feet) of airborne pathogen dispersal in a non-ICU setting. throughout study completion, up to 7 days
Primary correlation between the human aerosolization patterns and the severity of illness This outcome measure is to determine the correlation between the human aerosolization patterns and the severity of illness (fever, respiratory symptoms, malaise) in individual participants. throughout study completion, up to 7 days
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