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Emission Patterns of Respiratory Syncytial Virus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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:

  1. 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).
  2. 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).
  3. 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).
  4. 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

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Study Type : Observational
Estimated Enrollment : 29 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with RSV are eligible for enrollment. The results of routine in-house laboratory diagnostic tests such as the Respiratory Viral Panel (RVP) will be used to identify patients.
Criteria

Inclusion Criteria:

  • Patients > age 18, seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with RSV infection

Exclusion Criteria:

  • less than age 18
  • Mechanically intubated patients

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Werner Bischoff, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03909867    
Other Study ID Numbers: IRB00056852
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases