Emission Patterns of Respiratory Syncytial Virus

NCT03909867 | Terminated

• 1 other identifier: IRB00056852
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 4.Determine the correlation between the human aerosolization patterns and the severity of illness (fever, respiratory symptoms, malaise) in individual participants (super spreader?).

Conditions

RSV Infection; Aerosol Disease

Outcome Measures

Primary Outcomes (1)

• airborne emission patterns of Respiratory Syncytial Virus

  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)

  30min - 1 hour

Secondary Outcomes (1)

• Risk of RSV infection based on emission pattern

  72 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• less than age 18
• Mechanically intubated patients

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

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.

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Werner Bischoff, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 10, 2019
• Study Start: September 17, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 3, 2020
• Last Updated: February 28, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)