Emission Patterns of Respiratory Pathogens

NCT03491020 | Withdrawn

• 1 other identifier: IRB00038054
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pathogen Transmission

Keywords

Emission Patterns; Respiratory; Aerosolization; Airborne

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (11)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• positive respiratory pathogen tests

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

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.

Study Officials

• Werner Bischoff, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 6, 2018
• Study Start: December 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share