Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT04156568
Status:
UNKNOWN
Last Update Posted:
2019-11-07
First Post:
2019-11-06
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-11-06', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': 'During the 2 year follow-up study', 'description': 'Percentage of latent TB infections converted to active TB'}, {'measure': 'Proportion of adverse reactions', 'timeFrame': 'During the 2 year follow-up study', 'description': 'The incidence of adverse reactions in different treatment regimens'}, {'measure': 'Proportion of lost to follow-up', 'timeFrame': 'During the 2 year follow-up study', 'description': 'The proportion of lost to follow-up in different treatment regimens'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children', 'LTBI', 'Intervention'], 'conditions': ['Children LTBI']}, 'descriptionModule': {'briefSummary': 'The management of latent Mycobacterium tuberculosis infection is a new priority action for the WHO End Tuberculosis (TB) Strategy. However, national guidelines on latent tuberculosis infection testing and treatment have not yet been developed in children of China. Here, we present the results from the 3-year follow-up of a study that aimed to track the development of active disease in individuals with latent tuberculosis infection, identify priority populations for latent infection management, and explore the most suitable latent infection diagnostic approach.', 'detailedDescription': '1\\. Baseline analysis of a population-based, multicentre, prospective cohort study\n\n1. A baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18).\n2. Eligible participants were identifi ed by door-to-door survey with a household sampling design.\n3. Participants were screened for active tuberculosis and history of tuberculosis then used a tuberculin skin test and an interferon-γ release assay (QuantiFERON \\[QFT\\]) to test for latent infection.\n\n2\\. Incidence of active tuberculosis in individuals with latent tuberculosis infection in children of China under different treatment regimens\n\n1. Individuals who had tuberculosis infection at baseline (QFT-positivity or TST tuberculin reaction size \\[induration\\] of ≥10 mm) were divided and treatment with different therapeutic schedule.\n2. Follow-up study were conducted to assess the proportion of latent TB infection converted to active TB'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (0-18 years old).\n* Children with QFT-positive or TST induration ≥10 mm).\n\nExclusion Criteria:\n\n* Patients are allergic to anti-tuberculsis drugs.\n* Parents and/or guardians do not agree to participate in this study.\n* Participants with active tuberculosis.'}, 'identificationModule': {'nctId': 'NCT04156568', 'briefTitle': 'A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': 'A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children', 'orgStudyIdInfo': {'id': 'BCH_LTBI study 001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6INH Group', 'description': '10mg/kg 6INH were used in this group.', 'interventionNames': ['Drug: INH、RFT']}, {'type': 'EXPERIMENTAL', 'label': '3INH+RFT group', 'description': '3INH+RFTwere used in this grroup.', 'interventionNames': ['Drug: INH、RFT']}], 'interventions': [{'name': 'INH、RFT', 'type': 'DRUG', 'description': '6INH 10mg/kg 3INH+RFT 15mg/kg', 'armGroupLabels': ['3INH+RFT group', '6INH Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Adong Shen, Master', 'role': 'CONTACT', 'email': 'shenad16@hotmail.com', 'phone': '13370115087'}], 'facility': "Beijing Children's Hospital of Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'A-Dong Shen, Master', 'role': 'CONTACT', 'email': 'shenad16@hotmail.com', 'phone': '+86-010-59616898'}], 'overallOfficials': [{'name': 'A-Dong Shen, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Beijing Children's Hospital of Capital Medical University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief of China National Clinical Research Center for Respiratory Diseases', 'investigatorFullName': 'Adong Shen', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}