Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-30 @ 12:20 AM
Study NCT ID:
NCT05568368
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2022-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time-to-Detection in Culture of Mycobacterium Tuberculosis
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 705}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-04', 'studyFirstSubmitDate': '2022-10-04', 'studyFirstSubmitQcDate': '2022-10-04', 'lastUpdatePostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tuberculosis transmission', 'timeFrame': '2 months', 'description': 'duration of Tuberculosis transmission between an infected person and a contact case'}, {'measure': 'contact case tracking', 'timeFrame': '2 months', 'description': 'screening time for contact cases'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Tuberculoses']}, 'descriptionModule': {'briefSummary': 'determination if time-to-detection in cultures of M. tuberculosis samples is more discriminating than acid-fast staining in transmission'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '94 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all cases of pulmonary tuberculosis who had a sample analysed by the laboratory of bacteriology of Nice University Hospital, and that was positive in culture before treatment and of which contact cases were explored by the CLAT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have at least 1 contact case explored for tuberculosis\n* latent tuberculosis infection\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05568368', 'briefTitle': 'Time-to-Detection in Culture of Mycobacterium Tuberculosis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Time-to-Detection in Culture of Mycobacterium Tuberculosis : Performance for Assessing Index Cases Infectivity', 'orgStudyIdInfo': {'id': '22Infectio01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Index cases', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Index cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}