Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT03498534
Status:
WITHDRAWN
Last Update Posted:
2018-04-17
First Post:
2012-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D000085343', 'term': 'Latent Infection'}, {'id': 'D014376', 'term': 'Tuberculosis'}], '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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007538', 'term': 'Isoniazid'}], 'ancestors': [{'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007539', 'term': 'Isonicotinic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to administrative procedures', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-15', 'studyFirstSubmitDate': '2012-03-28', 'studyFirstSubmitQcDate': '2018-04-07', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of active TB', 'timeFrame': '6 months', 'description': 'Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Treatment', 'Latent infection', 'Tuberculosis', 'Interferon gamma'], 'conditions': ['Latent Tuberculosis', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': "Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts.\n\nElispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive HIV TST tuberculin\n\nExclusion Criteria:\n\n* Previous TB treatment Hepatic failure AIDS'}, 'identificationModule': {'nctId': 'NCT03498534', 'briefTitle': 'Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Salud Publica, Mexico'}, 'officialTitle': 'Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population', 'orgStudyIdInfo': {'id': 'CI-543'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with a -TST', 'description': 'In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months', 'interventionNames': ['Drug: Isoniazid 300Mg Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with a +TST', 'description': 'In patients with a +TST test researchers will test for HIV, hepatic function and we will take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months', 'interventionNames': ['Drug: Isoniazid 300 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HIV positive patients', 'description': 'The researchers will test hepatic function and take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months', 'interventionNames': ['Drug: Isoniazid 300 MG']}], 'interventions': [{'name': 'Isoniazid 300Mg Tab', 'type': 'DRUG', 'otherNames': ['Isoniazid 300 mgs.'], 'description': '-TST tests will receive isoniazid 300Mg Tab for 6 months', 'armGroupLabels': ['Patients with a -TST']}, {'name': 'Isoniazid 300 MG', 'type': 'DRUG', 'otherNames': ['Isoniazid'], 'description': '\\+ TST test will receive isoniazid 300MG Tab for 6 months', 'armGroupLabels': ['Patients with a +TST']}, {'name': 'Isoniazid 300 MG', 'type': 'DRUG', 'otherNames': ['Isoniazid 300 mg per day'], 'description': 'HIV positive patient will receive isoniazid 300MGTab for 6 months', 'armGroupLabels': ['HIV positive patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Garcia-Garcia Lourdes, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Salud Publica, Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Center of Research in Infectious Diseases', 'investigatorFullName': 'Ma. de Lourdes Garcia Garcia', 'investigatorAffiliation': 'Instituto Nacional de Salud Publica, Mexico'}}}}