Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01097005
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2010-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'takao.miki@mylan.com', 'title': 'Takao Miki, Medical Affairs', 'organization': 'Mylan EPD Japan'}, 'certainAgreement': {'otherDetails': 'The investigators will be granted by sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During treatment with clarithromycin up to 3.4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Clarithromycin', 'description': 'Those with an exposure', 'otherNumAtRisk': 441, 'otherNumAffected': 0, 'seriousNumAtRisk': 441, 'seriousNumAffected': 35}], 'seriousEvents': [{'term': 'Bile duct cancer', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Colon cancer', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Thrombocytopenia', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyponatraemia', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Decreased appetite', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Disorientation', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Somnolence', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Interstitial lung disease', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Drug eruption', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Erythema', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nephrotic syndrome', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Weight decreased', 'notes': 'Causal relationship with the study drug was rated as "possible" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bronchopulmonary aspergillosis', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Bacterial infection', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia bacterial', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Atypical mycobacterial infection', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lung neoplasm malignant', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hepatocellular carcinoma', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Anti-neutrophil cytoplasmic antibody positive vasculitis', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dehydration', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Loss of consciousness', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Optic neuritis', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Peripheral sensory neuropathy', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Subarachnoid haemorrhage', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vertigo positional', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arrhythmia', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure acute', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alveoliltis allergic', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haemoptysis', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Interstitial lung disease', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia aspiration', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumothorax', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Respiratory failure', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysphagia', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Large intestine polyp', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urticaria', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Calculus urinary', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Haematuria', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyrexia', 'notes': 'Causal relationship with the study drug was rated as "Not related" by the investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 441, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bacilli Negative Conversion Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin', 'description': 'Negative conversion / Yes'}], 'classes': [{'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the treatment with clarithromycin, from 40 days to 1232 days', 'description': 'Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of the bacilli negative conversion'}, {'type': 'SECONDARY', 'title': 'Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin', 'description': 'Those with an exposure'}], 'classes': [{'title': 'Effective', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}]}]}, {'title': 'Ineffective', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Deterioration', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Impossible to assess', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'When treatment with clarithromycin is discontinued, from 40 days to 1232 days', 'description': 'Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales ("Effective", "Ineffective", "Deterioration", "Impossible")', 'unitOfMeasure': 'Number of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of Clinical Global Improvement (CGI). Number of patients with each rank scale.'}, {'type': 'SECONDARY', 'title': 'Bacteriological Relapse Related to Duration of Clarithromycin Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clarithromycin', 'description': 'The subjects who completed the study'}], 'classes': [{'title': '0-14 months CLR', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '≥15 months CLR', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36 months', 'description': 'Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'End of study (completers). Analysis of bacteriological relapse.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clarithromycin', 'description': 'Those with an exposure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'number of participants who were enrolled for this study.', 'groupId': 'FG000', 'numSubjects': '466'}]}, {'type': 'Analysis of Safety', 'achievements': [{'comment': 'number of participants who could be measured for Adverse Events', 'groupId': 'FG000', 'numSubjects': '441'}]}, {'type': 'Analysis of NTM Lung Disease', 'achievements': [{'comment': 'number of participants who contributed to the Baseline data', 'groupId': 'FG000', 'numSubjects': '340'}]}, {'type': 'Analysis of Bacilli Negative Conversion', 'achievements': [{'comment': 'number of participants who were analysed for bacilli negative conversion', 'groupId': 'FG000', 'numSubjects': '285'}]}, {'type': 'Analysis of CGI', 'achievements': [{'comment': 'number of participants who were measured for Clinical Global Improvement (CGI)', 'groupId': 'FG000', 'numSubjects': '249'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '365'}]}], 'dropWithdraws': [{'type': 'Case Report Form not collected', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Subjects cannot visit the hospital', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Poor medication compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No examination data available', 'reasons': [{'groupId': 'FG000', 'numSubjects': '244'}]}, {'type': 'Deviation from exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Discontinuance by complication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}]}]}], 'recruitmentDetails': 'Patients will be registered using a central registration system. The investigators will register eligible patients with the registration center via FAX by 7 days after initiation of clarithromycin treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '340', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Clarithromycin', 'description': 'Those with an exposure'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}]}]}, {'title': '65-74 years', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}]}]}, {'title': '>=75 years', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '256', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 466}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2010-02-26', 'resultsFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2010-03-30', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-28', 'studyFirstPostDateStruct': {'date': '2010-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacilli Negative Conversion Rate', 'timeFrame': 'During the treatment with clarithromycin, from 40 days to 1232 days', 'description': 'Number of participants who tested positive for Bacilli before treatment and converted to Bacilli Negative at any point during the treatment with clarithromycin'}], 'secondaryOutcomes': [{'measure': 'Efficacy Evaluation Using the 4-rank Scale of "Effective", "Ineffective", "Deterioration", or "Impossible" by the Investigator', 'timeFrame': 'When treatment with clarithromycin is discontinued, from 40 days to 1232 days', 'description': 'Number of participants who evaluated for efficacy of clarithromycin with the 4-rank Scales ("Effective", "Ineffective", "Deterioration", "Impossible")'}, {'measure': 'Bacteriological Relapse Related to Duration of Clarithromycin Administration', 'timeFrame': '36 months', 'description': 'Number of patients who have bacteriological relapse related to duration of Clarithromycin (CLR) administration after initial negative conversion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mycobacterium Infections, Atypical'], 'conditions': ['Mycobacterium Infections, Atypical']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of long-term treatment with clarithromycin in patients with Non-tuberculous Mycobacterial Pulmonary Infections.', 'detailedDescription': 'Background: The revised 2007 American Thoracic Society/Infectious Diseases Society of America guidelines recommend a clarithromycin-based combination therapy for treatment of Mycobacterium avium complex (MAC) lung disease and stipulate approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient.\n\nObjectives: To obtain data on the clinical outcome of clarithromycin-based regimens by conducting a nationwide prospective study mainly of MAC lung disease.\n\nMethods: In accordance with the guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multi-drug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin -based regimen) until bacilli negative conversion on continual treatment for 1 year. Data were collected "pre-administration," "on the bacilli negative conversion," and "at 6 months after the end of treatment."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with Pulmonary non-tuberculous mycoplasma infection and who are indicated for treatment with Klaricid\n\nExclusion Criteria\n\n* Contraindications according to the package insert\n* Patients with a history of hypersensitivity to any ingredient of Klaricid\n* Patients who are receiving pimozide, ergot-containing products, or cisapride\n* Patients who have AIDS (Acquired Immune Deficiency Syndrome)'}, 'identificationModule': {'nctId': 'NCT01097005', 'briefTitle': 'Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'Special Investigation of Clarith/Klaricid in Patients With Non-tuberculous Mycobacterial Pulmonary Infections', 'orgStudyIdInfo': {'id': 'P10-765'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Klaricid', 'description': 'Those with an exposure'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36460', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Aichi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39122', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Akita', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36463', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'city': 'Ehime', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36470'}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36471', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36472', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36473', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Gifu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36474', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'city': 'Hiroshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36475', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Hyōgo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36482', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'city': 'Inzai', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36465', 'geoPoint': {'lat': 35.83479, 'lon': 140.16361}}, {'city': 'Ishikawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36483', 'geoPoint': {'lat': 26.42333, 'lon': 127.82139}}, {'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36484', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36485', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36486', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36487', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'city': 'Kitakyushu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54466', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kobe', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54468', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kochi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36488', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'city': 'Kofu', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36513', 'geoPoint': {'lat': 35.66667, 'lon': 138.56667}}, {'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39126', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36489', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36493', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Kyoto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39123', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Maebashi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54469', 'geoPoint': {'lat': 36.4, 'lon': 139.08333}}, {'city': 'Miyagi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36494', 'geoPoint': {'lat': 26.62566, 'lon': 128.18236}}, {'city': 'Miyazaki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36495', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36459', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nagoya', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36461', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Nara', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54465', 'geoPoint': {'lat': 34.68505, 'lon': 135.80485}}, {'city': 'Obihiro', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 37145', 'geoPoint': {'lat': 42.91722, 'lon': 143.20444}}, {'city': 'Okayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36497', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Okinawa', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39125', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 28404', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36492', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Ōita', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36496', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36501', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Saitama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54464', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36477', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36478', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sapporo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36481', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Seto', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36462', 'geoPoint': {'lat': 35.23333, 'lon': 137.1}}, {'city': 'Shimane', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36503', 'geoPoint': {'lat': 35.78334, 'lon': 139.79727}}, {'city': 'Shimotsuke', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36506', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36504', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36505', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'city': 'Takatsuki', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36499', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 15101', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36507', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36508', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36509', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36510', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 42710', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 54470', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'city': 'Toyohashi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36458', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'city': 'Wakayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36511', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'city': 'Wakayama', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 37144', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}, {'city': 'Yamaguchi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 36512', 'geoPoint': {'lat': 34.18333, 'lon': 131.46667}}, {'city': 'Yamanashi', 'country': 'Japan', 'facility': 'Site Reference ID/Investigator# 39124', 'geoPoint': {'lat': 35.67152, 'lon': 138.69827}}], 'overallOfficials': [{'name': 'Jun Kato, MD., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott Japan Co.,Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Please contact the investigator, and discuss with us.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Taisho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}