Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-31 @ 6:48 AM
Study NCT ID:
NCT04567368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-01
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TB-CAPT MTB/XDR Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-23', 'releaseDate': '2025-04-03'}], 'estimatedResultsFirstSubmitDate': '2025-04-03'}}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-16', 'size': 4143893, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-26T04:21', 'hasProtocol': True}, {'date': '2021-03-28', 'size': 522757, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-26T04:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 753}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of Xpert MTB/XDR assay', 'timeFrame': 'enrolment', 'description': 'Sensitivity and specificity of Xpert MTB/XDR assay vs. the composite reference standard for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of Xpert MTB/XDR assay compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately', 'timeFrame': 'enrolment', 'description': 'Sensitivity and specificity of Xpert MTB/XDR assay for detection of resistance to Isoniazid, Fluoroquinolones, Ethionamide, Second-line injectable anti-tuberculosis drugs compared to phenotypic anti-tuberculosis drug susceptibility testing and WGS separately'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis', 'Resistance Bacterial', 'Diagnoses Disease']}, 'descriptionModule': {'briefSummary': 'The Cepheid Xpert MTB/XDR cartridge, which runs on the same platform as Xpert MTB/RIF Ultra, has been developed to detect additional resistance to isoniazid, fluoroquinolones and second-line injectable anti-tuberculosis drugs and provides results within 2 hours and on primary samples. An evaluation of the the Xpert MTB/XDR assay is currently underway in clinical settings in South Africa, India and Moldova. The TB-CAPT MTB/XDR Study will add further diagnostic accuracy and feasibility data to the evidence base for the Xpert MTB/XDR assay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Respiratory specimens testing rifampicin-resistant Mtb positive on Xpert MTB/RIF Ultra.\n\nThe proposed study procedures would not affect the usual care of patients as we will utilise specimens that would ordinarily be discarded. Similarly, the reference standard tests (next generation sequencing) are non-routine tests not currently utilised for patient care in South Africa. These tests will be performed post hoc with patient identifiers removed.\n\nFor these reasons, we are proposing a waiver of informed consent for this diagnostic accuracy and feasibility study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mtb-positive, rifampicin-resistant respiratory specimen identified on Xpert MTB/RIF Ultra\n\nExclusion Criteria:\n\n* Residual SR-sputum mix not retained or not found\n* Patient previously included in the study\n\nExclusion for diagnostic accuracy and time-to-result endpoints:\n\n* Insufficient residual SR-sputum mix remaining for Xpert MTB/XDR (\\<2 ml)\n* Xpert MTB/XDR unsuccessful\n* No second / follow-up specimen received\n* Second / follow-up specimen culture-negative, contaminated or not available\n* Reference standard uninterpretable (phenotyping or WGS)\n\n * Where phenotypic susceptibility testing results are uninterpretable, specimens will still be included in WGS comparison\n * Where WGS results are uninterpretable, specimens will still be included in phenotypic susceptibility testing comparison'}, 'identificationModule': {'nctId': 'NCT04567368', 'briefTitle': 'TB-CAPT MTB/XDR Study', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Innovative New Diagnostics, Switzerland'}, 'officialTitle': 'Two-site Laboratory-based Diagnostic Accuracy and Feasibility Study of the Xpert MTB/XDR Assay for Detection of Isoniazid, Fluoroquinolone, Ethionamide and Second-line Injectable Anti-tuberculosis Drug Resistance', 'orgStudyIdInfo': {'id': 'TB042'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Xpert MTB/XDR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cape Town', 'country': 'South Africa', 'facility': 'University of Cape Town', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'University of the Witwatersrand', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Innovative New Diagnostics, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Cape Town', 'class': 'OTHER'}, {'name': 'Wits Health Consortium (Pty) Ltd', 'class': 'OTHER'}, {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, {'name': 'Swiss Tropical & Public Health Institute', 'class': 'OTHER'}, {'name': 'Heidelberg University', 'class': 'OTHER'}, {'name': 'African Society for Laboratory Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-04-03', 'type': 'RELEASE'}, {'date': '2025-04-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Foundation for Innovative New Diagnostics, Switzerland'}}}}