Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-05 @ 11:18 PM
Study NCT ID:
NCT00600769
Status:
COMPLETED
Last Update Posted:
2017-05-23
First Post:
2008-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015270', 'term': 'Mycobacterium avium-intracellulare Infection'}], 'ancestors': [{'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1991-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2008-01-14', 'studyFirstSubmitQcDate': '2008-01-14', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures', 'timeFrame': '6 months', 'description': 'neg culture x3( sputum conversion)'}], 'secondaryOutcomes': [{'measure': 'Microbiological cultures', 'timeFrame': '1yr', 'description': 'neg culture for 1 yr on treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MAC', 'NTM'], 'conditions': ['Nontuberculous Mycobacteria', 'Mycobacterium Avium Complex']}, 'descriptionModule': {'briefSummary': 'Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria', 'detailedDescription': 'Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet American Thoracic Society criteria for nontuberculous lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential lung pathogens (except for the coexistence of M. abscessus)\n* Age 18 years and older\n\nExclusion Criteria:\n\n* History of macrolide allergy\n* Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin\n* Children less than 18 years of age\n* If a menstruating female, not pregnant and on adequate birth control'}, 'identificationModule': {'nctId': 'NCT00600769', 'briefTitle': 'Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at Tyler'}, 'officialTitle': 'Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)', 'orgStudyIdInfo': {'id': '263'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'treatment of MAC and other NTM', 'description': 'Clarithromycin drug given twice daily.', 'interventionNames': ['Drug: Clarithromycin']}], 'interventions': [{'name': 'Clarithromycin', 'type': 'DRUG', 'otherNames': ['Biaxin'], 'description': 'Dosage dependent on clinical factors such as age, weight and patient-specific health status', 'armGroupLabels': ['treatment of MAC and other NTM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75708', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Richard J Wallace, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSCT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at Tyler', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman Department of Microbiology', 'investigatorFullName': 'Richard J. Wallace, Jr., M.D.', 'investigatorAffiliation': 'The University of Texas Health Science Center at Tyler'}}}}