Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-29 @ 6:54 AM
Study NCT ID:
NCT03497195
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2018-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Achieving Tuberculosis (TB) Control In Zambia
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2018-04-06', 'studyFirstSubmitQcDate': '2018-04-06', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'increase TB case detection', 'timeFrame': '6 months', 'description': 'comparison of two diagnostic tools (Chest Xray with CAD versus CRP) and Xpert Ultra for active community based TB case detection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '33616229', 'type': 'DERIVED', 'citation': 'Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.'}]}, 'descriptionModule': {'briefSummary': 'To achieve TB control, innovative case finding interventions are needed that will reach the broader affected population including those that do not access the health facilities. Systematic community case finding with highly sensitive screening and diagnostic tools are needed. At the facility level, the index of suspicion for TB by health care workers needs to be raised to ensure that all those that need TB screening are appropriately screened.', 'detailedDescription': 'The purpose of this study is to initiate sustained, active health facility and community-based case finding interventions to achieve improved TB case detection in high burden settings (Zambia) and contribute to TB control.\n\nThe interventions are expected to increase the impact of Xpert on TB case finding, thus increase TB case detection through scaling up of a combination of community level and facility level TB case finding interventions. The study will generate evidence on the added value of using Chest X-ray (CXR) screening at community level, whilst also comparing the performance of CXR with computer assisted diagnosis (CAD) and C-reactive protein (CRP) and symptoms as screening tools in terms sensitivity, specificity and cost effectiveness. Symptom screen alone has been shown to be suboptimal for screening as it misses a significant percentage of TB due to atypical presentation of TB in HIV-infected populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nProgram Implementation:\n\nInclusion criteria:\n\n* Any adult or child with TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)\n* Ability to produce sputum\n* Verbal consent of parent or guardian if \\< 18 years old\n\nOperations Research:\n\nInclusion criteria\n\n* Adults (18 years and older)\n* TB symptoms (weight loss, chest pain, shortness of breath, fever, cough, hemoptysis, night sweats)\n* Ability to provide a sputum sample\n* Willing to provide written informed consent\n* Willing to undergo full clinical evaluation\n* Willing to undergo a CXR'}, 'identificationModule': {'nctId': 'NCT03497195', 'acronym': 'TB', 'briefTitle': 'Achieving Tuberculosis (TB) Control In Zambia', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Achieving TB Control In Zambia Through Scale Up Of Innovative Tools And Proven Active TB Case Finding Interventions', 'orgStudyIdInfo': {'id': 'IRB-300001132'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Community level screening; Arm 1', 'description': 'use of chest X-ray plus Xpert Ultra for community level TB screening', 'interventionNames': ['Diagnostic Test: Screening at community level']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Community level screening: Arm 2', 'description': 'use of C-reactive Protein and Xpert Ultra for community level TB screening', 'interventionNames': ['Diagnostic Test: Screening at community level']}], 'interventions': [{'name': 'Screening at community level', 'type': 'DIAGNOSTIC_TEST', 'description': 'comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening', 'armGroupLabels': ['Community level screening: Arm 2', 'Community level screening; Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10102', 'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Center for Infectious Disease Research in Zambia (CIDRZ)', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Monde Muyoyeta, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Infectious Disease Research in Zambia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Stewart Reid', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}