Emission Patterns of Respiratory Pathogens

January 13, 2025 updated by: Wake Forest University Health Sciences
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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
particle size distribution patterns: ICU
Time Frame: throughout study completion, up to 7 days
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
Time Frame: throughout study completion, up to 7 days
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
Time Frame: throughout study completion, up to 7 days
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
Time Frame: throughout study completion, up to 7 days
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
Time Frame: throughout study completion, up to 7 days
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
Time Frame: throughout study completion, up to 7 days
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
Time Frame: throughout study completion, up to 7 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Werner Bischoff, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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