Emission Patterns of Respiratory Pathogens

Airborne transmission represents one of the most rapidly spreading and dangerous dissemination mechanisms for pathogens. Public health strategies to prevent and control the often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment, if available, 2) isolation and barrier precautions such as face masks, and 3) decontamination of the exposed areas and surfaces. A lack of understanding how these pathogens are transmitted hampers the ability to develop effective prevention measures. This study will be used to collect preliminary data of the emission patterns of respiratory pathogens.

Study Overview

• Status: Not yet recruiting
• Conditions: Pathogen Transmission

Detailed Description

Airborne transmission represents one of the most rapidly spreading and dangerous dissemination mechanisms for pathogens. The study team have been investigating bacterial and viral transmission routes and barrier precautions. In a recent clinical study, it was observed that Measles virus RNA was detected from a patient for at least up to 10 feet. In addition, the group has been studying barrier precautions (facemasks) for their ability to prevent the spread of aerosolized viruses. Finally, in a controlled lab setting the investigators have assessed the impact of environmental conditions (temperature, humidity) on pathogen transmission and the effect of UV-C light to prevent the spread of influenza. The purpose of this observational study is to describe the human aerosolization patterns of respiratory pathogens. The study team hypothesizes that the emission patterns of specific airborne pathogens varies between individual patients.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Werner Bischoff, MD; Phone Number: 336-716-5116; Email: wbischof@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients >18 years of age admitted to the ED or an inpatient care unit of Wake Forest Baptist Medical Center (WFBMC) will be screened for respiratory pathogens (performed as part of standard clinical care). Participants with positive respiratory pathogen tests will be consecutively enrolled.

Description

Inclusion Criteria:

• patients >18 years of age admitted to the ED or an inpatient care unit of Wake Forest Baptist Medical Center (WFBMC)
• Positive

Exclusion Criteria:

• positive respiratory pathogen tests

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

11

Cohorts and Interventions

Group / Cohort
Respiratory syncytial virus (RSV); Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify RSV.
Enteroviruses; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify enterovirus.
Adenoviruses; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify adenovirus.
Coronaviruses; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify coronavirus.
Metapneumoviruses; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify metapneumovirus.
Chlamydia pneumoniae; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify chlamydia pneumoniae.
Mycoplasma; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify mycoplasma.
Parainfluenza; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify parainfluenza.
Neisseria meningitides; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify neisseria meningitides.
Bordetella pertussis; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify bordetella pertussis.
Rhinovirus; Patients seen at the Emergency Department or admitted to the hospital with respiratory symptoms and diagnosed with a respiratory pathogen. A nasopharyngeal swab will be obtained to identify rhinovirus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
particle size distribution patterns: ICU	This outcome measure will determine the particle size distribution patterns of the pathogen in the intensive care unit (ICU).	throughout study completion, up to 7 days
particle size distribution patterns: non-ICU setting	This outcome measure will determine the particle size distribution patterns of the pathogen in the non-intensive care unit (ICU).	throughout study completion, up to 7 days
quantities of the pathogen: ICU	This outcome measure will determine the quantities of the pathogen in the intensive care unit (ICU).	throughout study completion, up to 7 days
quantities of the pathogen: non-ICU setting	This outcome measure will determine the quantities of the pathogen in the non-intensive care unit (ICU).	throughout study completion, up to 7 days
spatial model: ICU	This outcome measure will establish a spatial model (1 foot vs. 3- feet vs. 8-10 feet) of airborne pathogen dispersal in the ICU.	throughout study completion, up to 7 days
spatial model: non-ICU setting	This outcome measure will establish a spatial model (1 foot vs. 3- feet vs. 8-10 feet) of airborne pathogen dispersal in a non-ICU setting.	throughout study completion, up to 7 days
correlation between the human aerosolization patterns and the severity of illness	This outcome measure is to determine the correlation between the human aerosolization patterns and the severity of illness (fever, respiratory symptoms, malaise) in individual participants.	throughout study completion, up to 7 days

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Werner Bischoff, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (Actual): April 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Respiratory; Emission Patterns; Aerosolization; Airborne
• Other Study ID Numbers: IRB00038054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No