Emission Patterns of Respiratory Syncytial Virus
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|ClinicalTrials.gov Identifier: NCT03909867|
Recruitment Status : Suspended (The emergence of SARS-CoV-2 required a temporary hold of recruitment)
First Posted : April 10, 2019
Last Update Posted : September 7, 2020
The purpose of this observational study is to describe the environmental aerosolization patterns burden of RSV in the air and on surfaces in surrounding adult patients in a real-life setting. Specific objectives are to determine the particle size distribution and the quantity of airborne pathogens dispersed by symptomatic participants, to establish a spatial model of airborne emission and subsequent surface burden of RSV emission and dispersal in clinical settings (emergency department and inpatient units; 1 foot vs. 3-6 feet vs. 8-10 feet), and to obtain information regarding the potential association of illness severity and risk factors to the scale of airborne dispersal (e.g., super spreaders). This study will be used to collect data of the emission patterns of RSV. Subsequent investigations will help guide policymakers in the assessment of the airborne exposure risk to RSV and the implementation of appropriate infection prevent measures such as respirators and face masks.
The investigators hypothesize that the airborne emission patterns of Respiratory Syncytial Virus varies between individual patients. The investigators are proposing to assess the particle size and spatial distribution of airborne RSV emitted by affected patients within a routine care environment:
- Characterize individuals who develop respiratory illnesses caused by RSV in terms of demographics, co-morbid conditions, prior vaccinations (e.g., influenza vaccine, DTAP), use of antivirals, and severity of illness (fever, respiratory symptoms, malaise).
- Determine the particle size distribution patterns and quantities of the pathogen in two settings, an emergency department and an inpatient unit (ICU and non-ICU settings).
- Establish a spatial model (1 foot vs. 3-6 feet vs. 8-10 feet) of airborne pathogen dispersal and subsequent surface burden in two settings, an emergency department and an inpatient unit (ICU and non-ICU settings).
- Determine the correlation between the human aerosolization patterns and the severity of illness (fever, respiratory symptoms, malaise) in individual participants (super spreader?).
|Condition or disease|
|RSV Infection Aerosol Disease|
|Study Type :||Observational|
|Estimated Enrollment :||29 participants|
|Official Title:||Detection of the Human Aerosolization Patterns of Respiratory Syncytial Virus|
|Actual Study Start Date :||September 17, 2019|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||June 2021|
- airborne emission patterns of Respiratory Syncytial Virus [ Time Frame: 30min - 1 hour ]Determine the particle size distribution patterns and quantities of RSV pathogen, establish a spatial model (1 foot vs. 3-6 feet vs. 8-10 feet) of airborne pathogen dispersal and subsequent surface burden in two settings, an emergency department and an inpatient unit (ICU and non-ICU settings)
- Risk of RSV infection based on emission pattern [ Time Frame: 72 hours ]Determine the correlation between the human aerosolization patterns and the severity of illness (fever, respiratory symptoms, malaise) in individual participants (super spreader?).
Biospecimen Retention: Samples Without DNA
One nasopharyngeal swab sample from each participant will be used to confirm RSV infection and determine the amount of the pathogen carried by the individual.
One-time air samples will be collected using six-stage Andersen air sampling devices and settle plates at three locations, head of bed/chair two feet away from patient head, foot of bed/chair eight feet away from head, and at the exit of the patient room.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909867
|United States, North Carolina|
|Wake Forest School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Werner Bischoff, MD||Wake Forest University Health Sciences|