Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 5:22 PM
Study NCT ID:
NCT00567151
Status:
COMPLETED
Last Update Posted:
2009-06-23
First Post:
2007-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Co-Infection of NTM in Patients With Smear Positive Pulmonary TB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Sputa with positive AFB smear'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-20', 'studyFirstSubmitDate': '2007-12-02', 'studyFirstSubmitQcDate': '2007-12-02', 'lastUpdatePostDateStruct': {'date': '2009-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tuberculosis, Pulmonary']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (NTM) co-infection in patients with smear positive pulmonary TB. To detect the NTM co-infection, we will perform duplex PCR targeted for mycobacterial hsp 65 gene using sputa. In addition, the clinical significance of this co-infection will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients visited Seoul National University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New patients with pulmonary TB\n* Sputum AFB smear-positivity\n\nExclusion Criteria:\n\n* Non-applicable'}, 'identificationModule': {'nctId': 'NCT00567151', 'briefTitle': 'Co-Infection of NTM in Patients With Smear Positive Pulmonary TB', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Detection of Nontuberculous Mycobacterial co-Infection Using Duplex PCR for Mycobacterial Hsp 65 Gene and Its Clinical Significance in Patients With Smear Positive Pulmonary Tuberculosis', 'orgStudyIdInfo': {'id': 'H-0711-022-225'}, 'secondaryIdInfos': [{'id': 'Non-applicable'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jae-Joon Yim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National Univeristy Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jae-Joon Yim/Associate Professor, Division of Pulmonary and Critical Care Medicine', 'oldOrganization': 'Seoul National University Hospital'}}}}