RSV InfectionNCT03909867
Emission Patterns of Respiratory Syncytial Virus
An observational study of RSV Infection and Aerosol Disease, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RSV Infection, Aerosol Disease
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2019to 3 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients > age 18, seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with RSV infection
Who cannot join
- less than age 18
- Mechanically intubated patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Detection of the Human Aerosolization Patterns of Respiratory Syncytial Virus
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?).
Read the detailed description
Research Design and Methods The main objective of this study is to identify and determine airborne emission and subsequent surface burden patterns of RSV in naturally infected patients.
Patient Information:
Patients seen at the Emergency Department( ED) 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.
Setting:
Wake forest baptist medical center (WFBMC) is an 885 bed tertiary care teaching hospital. There are approximately 36,000 inpatient admissions and >89,000 ED visits annually (pediatric/adult). Air sampling is conducted in patient rooms under turbulent airflows (6 total air changes/hour) at approximately 20°C temperature and 40% Relative Humidity. Air is filtered by ANSI/ASHRAE 52.2 compliant endfilters with a minimum efficiency reporting value of 15.
Sampling:
One nasopharyngeal swab will be obtained from each subject. The sample will be used to confirm RSV infection and determine the amount of the pathogen carried by the individual. Samples will be inoculated into Becton Dickinson Universal Viral Transport System (VTM, BD Diagnostics, Franklin Lakes, NJ) for real-time reverse transcriptase PCR (rRT-PCR) analysis.
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 (11):
Samples will be collected in viral transport media (VTM), supplemented with RNA stabilization buffer (Qiagen AVL buffer) and carrier RNA and then stored at -80C. Carrier RNA will serve as both a carrier and an internal control by containing genomic RNA of the plant tobacco mosaic virus. A 540 ul volume of RNA sample will be purified with the QIAmp Viral RNA Mini Extraction Kit and concentrated approximately 10-fold. RSV serotypes A and B as well as the control viral tobacco mosaic virus RNA will be detected by reverse transcription and quantitative PCR. Additionally, nNasopharyngeal swab with also be used for cultures with inoculation in petri dish containing RSV specific media.
The surface burden of RSV will be assessed by placement of open standard Petri dishes filled with VTM at the three air sampling locations. The covers of the Petri dishes will be removed at the beginning of and closed after the air sampling session. Selected environmental surfaces will be sampled with sterile swabs moistened with VTM or TSB broth. A two square inch area will be swabbed once at three high-touch locations daily: head of the bed hand rail, middle of food tray table, and a table/horizontal surface at back of room (approximately 10 feet away past foot of bed). The swabs will be vortexed for 30 seconds, and processed as described for RSV detection in air samples.
During the sampling health care professional (HCP) and study staff will wear respirators (N-95) to reduce the risk of external contamination due to potential RSV carrier status. The respirators will be collected and a two square inch midsection of the respirator will be cut out using sterile scissors. The cut-outs are placed in 2mLs VTM or TSB broth and frozen. After thawing, samples are vortexed/agitated, and further processed as described for the RSV samples.
- Conditions
- RSV Infection, Aerosol Disease
- Medical subject headings
- Respiratory Syncytial Virus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30min - 1 hour
Secondary outcomes (1)
Risk of RSV infection based on emission pattern
Determine the correlation between the human aerosolization patterns and the severity of illness (fever, respiratory symptoms, malaise) in individual participants (super spreader?).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start17 Sep 2019
- Primary completion1 Feb 2020
- Study completion3 Feb 2020
Why it stopped: The emergence of SARS-CoV-2 required hold of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Bischoff, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909867
- Sponsor's protocol ID
- IRB00056852
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of the Human Aerosolization Patterns of Respiratory Syncytial Virus
- ClinicalTrials.gov ID
- NCT03909867
- Acronym / sponsor ID
- IRB00056852
- Conditions
- RSV Infection, Aerosol Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The emergence of SARS-CoV-2 required hold of recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?).
Detailed description
Research Design and Methods The main objective of this study is to identify and determine airborne emission and subsequent surface burden patterns of RSV in naturally infected patients.
Patient Information:
Patients seen at the Emergency Department( ED) 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.
Setting:
Wake forest baptist medical center (WFBMC) is an 885 bed tertiary care teaching hospital. There are approximately 36,000 inpatient admissions and >89,000 ED visits annually (pediatric/adult). Air sampling is conducted in patient rooms under turbulent airflows (6 total air changes/hour) at approximately 20°C temperature and 40% Relative Humidity. Air is filtered by ANSI/ASHRAE 52.2 compliant endfilters with a minimum efficiency reporting value of 15.
Sampling:
One nasopharyngeal swab will be obtained from each subject. The sample will be used to confirm RSV infection and determine the amount of the pathogen carried by the individual. Samples will be inoculated into Becton Dickinson Universal Viral Transport System (VTM, BD Diagnostics, Franklin Lakes, NJ) for real-time reverse transcriptase PCR (rRT-PCR) analysis.
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 (11):
Samples will be collected in viral transport media (VTM), supplemented with RNA stabilization buffer (Qiagen AVL buffer) and carrier RNA and then stored at -80C. Carrier RNA will serve as both a carrier and an internal control by containing genomic RNA of the plant tobacco mosaic virus. A 540 ul volume of RNA sample will be purified with the QIAmp Viral RNA Mini Extraction Kit and concentrated approximately 10-fold. RSV serotypes A and B as well as the control viral tobacco mosaic virus RNA will be detected by reverse transcription and quantitative PCR. Additionally, nNasopharyngeal swab with also be used for cultures with inoculation in petri dish containing RSV specific media.
The surface burden of RSV will be assessed by placement of open standard Petri dishes filled with VTM at the three air sampling locations. The covers of the Petri dishes will be removed at the beginning of and closed after the air sampling session. Selected environmental surfaces will be sampled with sterile swabs moistened with VTM or TSB broth. A two square inch area will be swabbed once at three high-touch locations daily: head of the bed hand rail, middle of food tray table, and a table/horizontal surface at back of room (approximately 10 feet away past foot of bed). The swabs will be vortexed for 30 seconds, and processed as described for RSV detection in air samples.
During the sampling health care professional (HCP) and study staff will wear respirators (N-95) to reduce the risk of external contamination due to potential RSV carrier status. The respirators will be collected and a two square inch midsection of the respirator will be cut out using sterile scissors. The cut-outs are placed in 2mLs VTM or TSB broth and frozen. After thawing, samples are vortexed/agitated, and further processed as described for the RSV samples.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients > age 18, seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with RSV infection
Key exclusion criteria (2 listed)
- less than age 18
- Mechanically intubated patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Risk of RSV infection based on emission pattern
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: The emergence of SARS-CoV-2 required hold of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for RSV Infection
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Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
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RSV Burden in Outpatient and Hospital Settings
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Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
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Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Bischoff, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection and Aerosol Disease, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The emergence of SARS-CoV-2 required hold of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airborne emission patterns of Respiratory Syncytial Virus (time frame: 30min - 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.