Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06110533
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2023-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-04-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and risk factors for pulmonary tuberculosis in children hospitalized at Strasbourg University Hospital between 2012 and 2022', 'timeFrame': '1 month after hospitalization for pulmonary tuberculosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary tuberculosis', 'Tuberculosis in children', 'Childhood tuberculosis', 'Mycobacterium tuberculosis'], 'conditions': ['Pulmonary Tuberculosis']}, 'descriptionModule': {'briefSummary': 'Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide.\n\nIn France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019.\n\nPulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis.\n\nThe aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Child (1 to 17 years old) hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child (1 to 17 years old)\n* Child hospitalized for pulmonary tuberculosis at Strasbourg University Hospital between January 1, 2012 and December 31, 2022.\n* Child and/or his/her parental authority who have not expressed their opposition to the reuse of data for scientific research purposes.\n\nExclusion Criteria:\n\n\\- Subject and/or their parental authority having expressed their opposition to the re-use of the child's data for scientific research purposes."}, 'identificationModule': {'nctId': 'NCT06110533', 'acronym': 'TPE', 'briefTitle': 'Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Descriptive Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals', 'orgStudyIdInfo': {'id': '8907'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurence WEISS, MD', 'role': 'CONTACT', 'email': 'laurence.weiss@chru-strasbourg.fr', 'phone': '33 3 88 12 83 95'}, {'name': 'Laurence WEISS, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'asma BOUDERBALAH, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Laurence WEISS, MD', 'role': 'CONTACT', 'email': 'laurence.weiss@chru-strasbourg.fr', 'phone': '33 3 88 12 83 95'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}