Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT03909867
Other study ID # IRB00056852
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date September 17, 2021
Est. completion date September 2025

Study information

Verified date March 2024
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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?).


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.


Recruitment information / eligibility

Status Suspended
Enrollment 29
Est. completion date September 2025
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wake Forest School of Medicine 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 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 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?). 72 hours
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03698084 - RESCEU: Defining the Burden of RSV Disease
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05587478 - A Study of EDP-323 in Healthy Subjects Phase 1
Recruiting NCT06180993 - Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
Recruiting NCT06259487 - Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis. N/A
Not yet recruiting NCT04144816 - Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants
Completed NCT01090557 - Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study N/A
Terminated NCT01475305 - Intranasal Challenge of Healthy Adults With Respiratory Syncytial Virus (RSV) Phase 1
Not yet recruiting NCT05928507 - FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
Completed NCT03062917 - Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis N/A
Completed NCT03691623 - A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model Phase 2
Completed NCT03387137 - Evaluating the Infectivity, Safety, and Immunogenicity of a Respiratory Syncytial Virus Vaccine (RSV 6120/∆NS2/1030s) in RSV-Seropositive Children and RSV-Seronegative Infants and Children Phase 1
Completed NCT05070975 - Severity of RSV Infections in Twins
Active, not recruiting NCT04938830 - Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) Phase 3
Recruiting NCT05568706 - A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. Phase 2
Completed NCT03755778 - Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects Phase 1
Completed NCT01483911 - ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers Phase 1
Recruiting NCT06170242 - A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model Phase 2
Completed NCT03750383 - Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects Phase 1
Completed NCT05118386 - Safety, Tolerability, and Pharmacokinetics of RSV Monoclonal Antibody RSM01 in Healthy Adults Phase 1