Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-28 @ 11:18 AM
Study NCT ID:
NCT04568967
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TB-CAPT EXULTANT - HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D015658', 'term': 'HIV Infections'}], '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'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003672', 'term': 'Defecation'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-13', 'size': 1830304, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-02T04:29', 'hasProtocol': True}, {'date': '2022-12-06', 'size': 1286696, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-02T04:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-28', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment', 'timeFrame': '72 hours after enrolment', 'description': 'The proportion of participants diagnosed with microbiologically confirmed TB and started on TB treatment within 72 hours of enrolment, separately for intervention and control arm. The numerator is the number of participants per study arm who are diagnosed with microbiologically confirmed TB and start on treatment within 72 hours of enrolment. The denominator is the number of participants enrolled per study arm. We will compare this indicator between both study arms.'}], 'secondaryOutcomes': [{'measure': 'Eight-week all-cause mortality', 'timeFrame': '8 weeks after enrolment', 'description': 'Eight-week all-cause mortality (main secondary endpoint) among all participants enrolled. The numerator will be number of deaths during eight weeks after enrolment, the denominator is the number of participants enrolled. We will compare this indicator between both study arms.'}, {'measure': 'The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment.', 'timeFrame': '72 hours after enrolment', 'description': 'The proportion of participants who are diagnosed with TB (irrespective of bacteriological confirmation) and started TB treatment within 72 hours of enrolment. The numerator is the number of participants diagnosed with TB (with or without bacteriological confirmation) who started treatment within 72 hours of enrolment; the denominator is the number of participants enrolled.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis', 'HIV Coinfection', 'Diagnoses Disease']}, 'referencesModule': {'references': [{'pmid': '39148008', 'type': 'DERIVED', 'citation': 'Mangu C, Cossa M, Ndege R, Khosa C, Leukes V, de la Torre-Perez L, Machiana A, Kivuma B, Mnzava D, Zachariah C, Manjate P, Tagliani E, Schacht C, Buech J, Singh S, Ehrlich J, Riess F, Sanz S, Kranzer K, Cox H, Sabi I, Nguenha D, Meggi B, Weisser M, Ntinginya N, Schumacher S, Ruhwald M, Penn-Nicholson A, Garcia-Basteiro AL; TB-CAPT Consortium. Expanding Xpert MTB/RIF Ultra(R) and LF-LAM testing for diagnosis of tuberculosis among HIV-positive adults admitted to hospitals in Tanzania and Mozambique: a randomized controlled trial (the EXULTANT trial). BMC Infect Dis. 2024 Aug 15;24(1):831. doi: 10.1186/s12879-024-09651-z.'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of this study is to assess the potential of an expanded TB testing strategy to increase the number of HIV-positive patients with microbiologically diagnosed TB who are started on treatment in adult wards of sub-Saharan Africa.', 'detailedDescription': "To investigate the effect of an expanded TB screening strategy among HIV-positive patients admitted to hospital (including Ultra on sputum, stool and urine, and AlereLAM on urine, performed regardless of presence of TB symptoms) on the proportion of microbiologically-confirmed TB cases starting treatment within 72 hours of enrolment, compared to Ultra testing (on sputum/any tissue) and AlereLAM (on urine) in only those patients who are symptomatic for TB or fulfilling WHO testing recommendations.\n\nto assess the impact of this screening strategy on 2-month all-cause mortality.\n\n• to assess the feasibility of multiple specimens' collection for TB diagnosis within 72 hours of enrolment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults (18 years old and above)\n2. Confirmed HIV infection by serology (including both antiretroviral (ART)- naïve and experienced)\n3. Admitted to the hospital (adult medical wards) at the time of enrolment.\n\nExclusion Criteria:\n\n1. Unable to provide informed consent (if no authorized relatives are in the position to provide the consent)\n2. Living outside the catchment area of the participating hospital(s)\n3. with plans to migrate outside the catchment area within 2 months after recruitment.\n4. Currently receiving anti-TB therapy or having received anti TB therapy in the last 6 months prior to enrolment\n5. Receiving preventive TB treatment in the preceding 6 months\n6. Patients admitted for traumatic reasons, acute abdomen, delivery (maternal conditions), or for planned/scheduled surgery.\n7. Referred from other hospital.'}, 'identificationModule': {'nctId': 'NCT04568967', 'briefTitle': 'TB-CAPT EXULTANT - HIV', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Innovative New Diagnostics, Switzerland'}, 'officialTitle': 'Expanding Xpert Ultra Testing for TB Diagnosis Among HIV-positive Patients Admitted to Hospital in Africa', 'orgStudyIdInfo': {'id': 'TB043-3/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention arm', 'description': 'The intervention arm for this trial consists of HIV patients with TB testing performed regardless of presence of TB symptoms. Testing will be done on expectorated sputum, stool and concentrated urine with Ultra, and urine with AlereLAM.\n\nTo fulfil exploratory objectives, we will also collect and store 2x tongue swabs for molecular TB diagnostic assay (Xpert Ultra and/or LumiraDx) testing, blood for testing with CRP, and urine samples which will be stored for retrospective FujiLAM testing and analysis.', 'interventionNames': ['Diagnostic Test: Concentrated urine with Xpert Ultra', 'Diagnostic Test: Stool with Xpert Ultra']}, {'type': 'NO_INTERVENTION', 'label': 'control arm', 'description': 'The control arm for this trial will consist of patients managed according to the current WHO recommended TB testing practices for HIV positive inpatients (as of Q1 2020).\n\nTB testing will be done as follows:\n\nSputum Ultra performed whenever the patient has cough, fever, weight loss over night sweats and/or Ultra performed on any tissue (including lymph nodes) from patients with clinical suspicion of extrapulmonary TB.\n\nand/or: Urine Alere TB-LAM performed if patients have signs and symptoms of TB (pulmonary and/or extrapulmonary), or with advanced HIV disease, or who are seriously ill, or else irrespective of signs and symptoms of TB, but combined with a CD4 cell count of less than 200 cells/mm .'}], 'interventions': [{'name': 'Concentrated urine with Xpert Ultra', 'type': 'DIAGNOSTIC_TEST', 'description': 'Molecular TB diagnostic test on urine', 'armGroupLabels': ['intervention arm']}, {'name': 'Stool with Xpert Ultra', 'type': 'DIAGNOSTIC_TEST', 'description': 'Molecular TB diagnostic test on stool', 'armGroupLabels': ['intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1929', 'city': 'Manhiça', 'state': 'Vila Da Manhiça', 'country': 'Mozambique', 'facility': 'Centro de Investigação em Saúde de Manhiça-Fundação', 'geoPoint': {'lat': -25.40222, 'lon': 32.80722}}, {'zip': '1100', 'city': 'Maputo', 'country': 'Mozambique', 'facility': 'Instituto Nacional de Saúde (INS)', 'geoPoint': {'lat': -25.96553, 'lon': 32.58322}}, {'zip': '53502', 'city': 'Bagamoyo', 'country': 'Tanzania', 'facility': 'Ifakara Health Institute (IHI)', 'geoPoint': {'lat': -6.44222, 'lon': 38.90422}}, {'zip': '2410', 'city': 'Mbeya', 'country': 'Tanzania', 'facility': 'National Institute of Medical Research (NIMR)', 'geoPoint': {'lat': -8.9, 'lon': 33.45}}], 'overallOfficials': [{'name': 'Alberto García-Basteiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barcelona Institute for Global Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'After publication of the primary peer-reviewed manuscript', 'ipdSharing': 'YES', 'description': 'Individual, de-identified participant data may be shared, including data dictionaries. Available documents include the study protocol and statistical analysis plan. Templates of the informed consent forms may be shared upon request. The data will be available immediately following publication with no end date, will be shared with anyone who wishes to access them, and will be available for any purpose of analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Innovative New Diagnostics, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Instituto Nacional de Saúde, Mozambique', 'class': 'OTHER_GOV'}, {'name': 'Centro de Investigação em Saúde de Manhiça', 'class': 'OTHER'}, {'name': 'National Institute for Medical Research, Tanzania', 'class': 'OTHER_GOV'}, {'name': 'Ifakara Health Institute', 'class': 'OTHER'}, {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, {'name': 'Swiss Tropical & Public Health Institute', 'class': 'OTHER'}, {'name': 'African Society for Laboratory Medicine', 'class': 'UNKNOWN'}, {'name': 'Heidelberg University', 'class': 'OTHER'}, {'name': 'Barcelona Institute for Global Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}