Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-20 @ 3:31 PM
Study NCT ID:
NCT03822156
Status:
COMPLETED
Last Update Posted:
2019-06-25
First Post:
2019-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D018088', 'term': 'Tuberculosis, Multidrug-Resistant'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046508', 'term': 'Culture Techniques'}], 'ancestors': [{'id': 'D066298', 'term': 'In Vitro Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '8 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-23', 'studyFirstSubmitDate': '2019-01-25', 'studyFirstSubmitQcDate': '2019-01-25', 'lastUpdatePostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TLSD', 'timeFrame': 'at baseline', 'description': 'Treatment of anti-TB medication to Last Smear positive Duration'}, {'measure': 'TLCD', 'timeFrame': 'at baseline', 'description': 'Treatment of anti-TB medication to Last Culture positive Duration'}, {'measure': 'ACSD', 'timeFrame': 'at baseline', 'description': 'AFB Culture-Smear positive Dissociation'}, {'measure': 'TCV/RLV', 'timeFrame': 'at baseline', 'description': 'TCV/RLV (Total Cavity\\[ies\\] Volume/Total Lung Volume) on enhance CT'}, {'measure': 'TTV/RLV', 'timeFrame': 'at baseline', 'description': 'TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT'}], 'secondaryOutcomes': [{'measure': 'Radiological measure for Tb lesions including cavity size, number', 'timeFrame': 'at baseline', 'description': 'analysis by BioView Duet Workstation (BioView Ltd, Rehovot, Israel) \\[cavitary pulmonary TB\\]'}, {'measure': 'Admission Duration', 'timeFrame': 'at baseline', 'description': "The patients' Hospital admission duration \\[cavitary pulmonary TB and endobronchial TB\\]"}, {'measure': 'Isolation Duration', 'timeFrame': 'at baseline', 'description': "The patients' isolation duration during hospital admission \\[cavitary pulmonary TB and endobronchial TB\\]"}, {'measure': 'Hemoptysis /Bronchial artery embolization (BAE)', 'timeFrame': 'at baseline', 'description': "The patients' history of Hemoptysis /Bronchial artery embolization (BAE) \\[cavitary pulmonary TB and endobronchial TB\\]"}, {'measure': 'TB PCR, XPERT', 'timeFrame': 'at baseline', 'description': "The patients' result of TB PCR, XPERT \\[cavitary pulmonary TB and endobronchial TB\\]"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cavitary Pulmonary Tuberculosis', 'Acid fast bacilli (AFB)', 'Isolation', 'Endobronchial Tuberculosis', 'Transmission', 'Drug susceptible test (DST)', 'Ant-tuberculous agent'], 'conditions': ['Tuberculosis', 'Tuberculosis, Pulmonary', 'Cavity', 'Bronchoscopy', 'Acid Fast Bacilli Infection', 'Multi-drug Resistant Tuberculosis', 'Transmission', 'Insolation']}, 'descriptionModule': {'briefSummary': 'This study is a retrospective cohort study. The purpose of this study is to investigate clinical features of the patients with the cavitary pulmonary tuberculosis (TB) and endobronchial TB from the patients who have been registered in this hospital for treatment and follow-up, as part of the "PPM Project (Private-Public Mix project) for Korean National Tuberculosis Control" introduced in Korea since 2007.', 'detailedDescription': 'Cavitary pulmonary tuberculosis (TB) is known to remain its Infectivity for a longer period of time than the non-cavitary pulmonary TB, which is usually almost inactivated its infectivity within two weeks after the administration of the anti - TB drugs.\n\nHowever, there are few studies on this, so it is not known how long the infectivity persists, whether there is a correlation with the number of cavities or the size of the cavities between persistence of infectivity.\n\nMeanwhile, endobronchial TB is known also to be highly infectious, unlike simple pulmonary TB.\n\nIt is not known how long infectivity can persist after the administration of anti-TB medication, and whether there is any difference in persistence of infectivity regarding the clinical characteristics of endobronchial TB.\n\nIn this study, investigators will analyze the retrospective data analysis of UUH-PPM Cohort, a cohort of PPM project patients in the Ulsan University Hospital (UUH).\n\nThe PPM project is a "Private-Public Mix project" for the eradication of tuberculosis from Korea, which the Korean government and private medical institutions have been conducting since 2007.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients who have been registered in this hospital for treatment and follow-up, as part of the "PPM Project (Private-Public Mix project) for Korean National Tuberculosis Control" introduced in Korea since 2007.', 'healthyVolunteers': False, 'eligibilityCriteria': "A. Cavitary Pulmonary TB Group\n\nInclusion Criteria:\n\n1. Aged 18 years and older\n2. The patient who has the cavitary pulmonary TB\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Any Malignant patient\n3. Patients with bacterial or viral or fungal pneumonia based on the judgment of the attending physician\n4. Patients who had a history of any pulmonary cystic lesion such as infected bulla, bullous emphysema\n5. Patients who were diagnosed with pulmonary fungal infection or previous its history or any documented culture of the fungus from a bronchial sample including sputum\n6. Patients who were diagnosed with bronchiectasis\n7. Patients who were diagnosed with NTM-PD (non-tuberculous mycobacterial pulmonary disease) or any documented culture of NTM from a bronchial sample including sputum\n8. Patients who were diagnosed with connective tissue disease such as Wegener's granulomatosis, SLE\n9. Patients who were diagnosed with TB destroyed lung\n10. Patients who were diagnosed with congenital lung disease such as Congenital Cystic Adenomatoid Malformation (CCAM), pulmonary sequestration\n11. Patients who were diagnosed with interstitial lung disease such as Lymphangioleiomyomatosis (LAM), idiopathic pulmonary fibrosis (IPF)\n12. Patients who were diagnosed with culture-negative pulmonary TB\n13. Patients who did not take anti-TB medication more than twice a week on average\n14. Patients who were diagnosed with sarcoidosis\n15. Patients who were diagnosed with paragonimiasis\n16. Patients who were diagnosed with pulmonary thromboembolism due to excluding pulmonary infarction\n17. The patient who did not consent\n18. Patients who were diagnosed with MDR/XDR TB through AFB culture\n\nB. Endobronchial TB Group\n\nInclusion Criteria:\n\n1. Aged 18 years and older\n2. The patient who has the endobronchial TB through bronchoscopy\n\nExclusion Criteria:\n\n1. Age \\< 18 years\n2. Patient who was not consented"}, 'identificationModule': {'nctId': 'NCT03822156', 'briefTitle': 'Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulsan'}, 'officialTitle': 'Clinical Analysis of the Patients With Cavitary Pulmonary Tuberculosis and Endobronchial Tuberculosis in the Private-Public Mix Project for Tuberculosis, Ulsan University Hospital Cohort (PPM-UUH Cohort)', 'orgStudyIdInfo': {'id': 'UUlsan'}, 'secondaryIdInfos': [{'id': 'KCT0003707', 'type': 'OTHER', 'domain': 'Clinical Research Information Service, Republic of Korea'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cavitary Pulmonary Tuberculosis', 'description': 'The patients who are diagnosed with the cavitary pulmonary tuberculosis', 'interventionNames': ['Other: Observation of AFB smear/culture']}, {'label': 'Endobronchial Tuberculosis', 'description': 'The patients who are diagnosed with the endobronchial tuberculosis', 'interventionNames': ['Other: Observation of AFB smear/culture']}], 'interventions': [{'name': 'Observation of AFB smear/culture', 'type': 'OTHER', 'description': 'Observation of the patients from group for their AFB smear/culture results', 'armGroupLabels': ['Cavitary Pulmonary Tuberculosis', 'Endobronchial Tuberculosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44033', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital, 877 Bangeojin Sunwhando-ro', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Kwang Won Seo, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ulsan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulsan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ulsan University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor, division of pulmonology, dept. of internal medicine', 'investigatorFullName': 'Kwang Won Seo', 'investigatorAffiliation': 'University of Ulsan'}}}}