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Emission Patterns of Respiratory Pathogens

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ClinicalTrials.gov Identifier: NCT03491020
Recruitment Status : Not yet recruiting
First Posted : April 6, 2018
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Emission Patterns of Respiratory Pathogens
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

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.



Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

  7. 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.


Biospecimen Retention:   Samples With DNA
The results of routine in-house laboratory diagnostic tests such as the Respiratory Viral Panel (RVP), serology tests or bacterial cultures will be used to identify patients.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491020


Contacts
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Contact: Werner Bischoff, MD 336-716-5116 wbischof@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Werner Bischoff, MD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03491020    
Other Study ID Numbers: IRB00038054
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Emission Patterns
Respiratory
Aerosolization
Airborne