Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-31 @ 5:54 AM
Study NCT ID:
NCT04600232
Status:
UNKNOWN
Last Update Posted:
2020-10-23
First Post:
2020-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TB-LAM in the Diagnosis of TB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'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'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2020-10-20', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity against microbiological reference standard', 'timeFrame': '2 months', 'description': 'Number of TB-LAM positive/Number of positive by culture or Gene Xpert'}, {'measure': 'Specificity against microbiological reference standard', 'timeFrame': '2 months', 'description': '1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear'}], 'secondaryOutcomes': [{'measure': 'Sensitivity against composite reference standard', 'timeFrame': '2 months', 'description': 'Number of TB-LAM positive/Number of active TB diagnosed clinically'}, {'measure': 'Specificity against composite reference standard', 'timeFrame': '2 months', 'description': '1-Number of TB-LAM negative/Number of TB excluded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections', 'Tuberculosis', 'Non-Tuberculous Mycobacterial Pneumonia']}, 'descriptionModule': {'briefSummary': 'Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized HIV-infected patients.\n* Willing to participate into the study.\n\nExclusion Criteria:\n\n* Already diagnosed with active TB\n* Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.'}, 'identificationModule': {'nctId': 'NCT04600232', 'briefTitle': 'TB-LAM in the Diagnosis of TB', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shanghai Public Health Clinical Center'}, 'officialTitle': 'Clinical Utility of TB-LAM in the Diagnosis of Active TB in Hospitalized HIV-infected Patients', 'orgStudyIdInfo': {'id': 'TB-LAM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnosis arm', 'description': 'Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture', 'interventionNames': ['Diagnostic Test: Alere TB-LAM']}], 'interventions': [{'name': 'Alere TB-LAM', 'type': 'DIAGNOSTIC_TEST', 'description': 'Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.', 'armGroupLabels': ['Diagnosis arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jun Chen, M.D', 'role': 'CONTACT', 'email': 'qtchenjun@163.com', 'phone': '+86-21-37990333', 'phoneExt': '3222'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Participant data without individual identification can be provided upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Public Health Clinical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Shanghai Public Health Clinical Center', 'investigatorFullName': 'Jun Chen', 'investigatorAffiliation': 'Shanghai Public Health Clinical Center'}}}}