Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT03491020
Status:
WITHDRAWN
Last Update Posted:
2025-01-15
First Post:
2018-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emission Patterns of Respiratory Pathogens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Trial has been withdrawn due to logistical support issues.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2018-03-30', 'studyFirstSubmitQcDate': '2018-03-30', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'particle size distribution patterns: ICU', 'timeFrame': 'throughout study completion, up to 7 days', 'description': 'This outcome measure will determine the particle size distribution patterns of the pathogen in the intensive care unit (ICU).'}, {'measure': 'particle size distribution patterns: non-ICU setting', 'timeFrame': 'throughout study completion, up to 7 days', 'description': 'This outcome measure will determine the particle size distribution patterns of the pathogen in the non-intensive care unit (ICU).'}, {'measure': 'quantities of the pathogen: ICU', 'timeFrame': 'throughout study completion, up to 7 days', 'description': 'This outcome measure will determine the quantities of the pathogen in the intensive care unit (ICU).'}, {'measure': 'quantities of the pathogen: non-ICU setting', 'timeFrame': 'throughout study completion, up to 7 days', 'description': 'This outcome measure will determine the quantities of the pathogen in the non-intensive care unit (ICU).'}, {'measure': 'spatial model: ICU', 'timeFrame': 'throughout study completion, up to 7 days', 'description': 'This outcome measure will establish a spatial model (1 foot vs. 3- feet vs. 8-10 feet) of airborne pathogen dispersal in the ICU.'}, {'measure': 'spatial model: non-ICU setting', 'timeFrame': 'throughout study completion, up to 7 days', 'description': '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.'}, {'measure': 'correlation between the human aerosolization patterns and the severity of illness', 'timeFrame': 'throughout study completion, up to 7 days', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emission Patterns', 'Respiratory', 'Aerosolization', 'Airborne'], 'conditions': ['Pathogen Transmission']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients \\>18 years of age admitted to the ED or an inpatient care unit of Wake Forest Baptist Medical Center (WFBMC)\n* Positive\n\nExclusion Criteria:\n\n* positive respiratory pathogen tests'}, 'identificationModule': {'nctId': 'NCT03491020', 'briefTitle': 'Emission Patterns of Respiratory Pathogens', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Emission Patterns of Respiratory Pathogens', 'orgStudyIdInfo': {'id': 'IRB00038054'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Respiratory syncytial virus (RSV)', 'description': '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.'}, {'label': 'Enteroviruses', 'description': '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.'}, {'label': 'Adenoviruses', 'description': '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.'}, {'label': 'Coronaviruses', 'description': '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.'}, {'label': 'Metapneumoviruses', 'description': '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.'}, {'label': 'Chlamydia pneumoniae', 'description': '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.'}, {'label': 'Mycoplasma', 'description': '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.'}, {'label': 'Parainfluenza', 'description': '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.'}, {'label': 'Neisseria meningitides', 'description': '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.'}, {'label': 'Bordetella pertussis', 'description': '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.'}, {'label': 'Rhinovirus', 'description': '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.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Werner Bischoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}