Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-25 @ 7:32 AM
Study NCT ID:
NCT02861768
Status:
COMPLETED
Last Update Posted:
2023-04-21
First Post:
2016-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving the Diagnostic of Tuberculosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 991}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03-22'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2016-08-05', 'studyFirstSubmitQcDate': '2016-08-09', 'lastUpdatePostDateStruct': {'date': '2023-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with microbiological diagnosis of M. tuberculosis infection', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'pulmonary tuberculosis diagnostic time.', 'timeFrame': '3years'}, {'measure': 'Prevalence of diagnosed patients Beijing', 'timeFrame': '3 years'}, {'measure': 'Direct cost of microbiological diagnosis of extra Beijing genotype', 'timeFrame': '3 years', 'description': '(compared to the cost of the kit TB), reported the percentage of patients diagnosed Beijing.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': 'The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.\n\nHypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal.\n\nSecondary\n\n1. Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely.\n2. Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely.\n3. Beijing genotype prevalence among patients with pulmonary tuberculosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient taken for microbiological examinations "kit mycobacterium"\n* Patient Major (\\> 18 years).\n* Patient who freely signed the informed written consent.\n* Patient affiliated to a system of social security. Exclusion criteria\n* Patient minor (\\<18 years).\n* Patient pregnant or nursing.\n* Major Patient under guardianship.\n* Private Patient liberty or under court order.\n* Patient refusing to sign the informed consent form.'}, 'identificationModule': {'nctId': 'NCT02861768', 'briefTitle': 'Improving the Diagnostic of Tuberculosis', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Improving the Diagnostic of Tuberculosis', 'orgStudyIdInfo': {'id': '2012-49'}, 'secondaryIdInfos': [{'id': '2012-A01598-35', 'type': 'REGISTRY', 'domain': 'ansm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'diagnosis of M.tuberculosis infection', 'interventionNames': ['Biological: Pharyngeal swab']}], 'interventions': [{'name': 'Pharyngeal swab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['diagnosis of M.tuberculosis infection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'catherine GEINDRE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hopitaux De Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}