[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517554":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":7,"responsibleParty":18,"collaborators":7,"id":20,"slug":21,"hasResults":22,"nctId":23,"briefTitle":24,"officialTitle":25,"acronym":26,"eligibilityCriteria":27,"healthyVolunteers":22,"sex":28,"minAge":29,"maxAge":7,"enrollmentInfo":30,"targetDuration":7,"studyType":33,"phases":7,"briefSummary":34,"conditions":35,"keywords":37,"overallStatus":47,"whyStopped":7,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":7},{"fullName":5,"class":6},"Foundation for Innovative New Diagnostics, Switzerland","OTHER",null,[9,14],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Pamela Nabeta, Medical Doctor","CONTACT","+41 22 710 27 87","pamela.nabeta@finddx.org",{"name":15,"role":11,"phone":16,"phoneExt":7,"email":17},"Charu Paliwal, Master in Biotechnology","09560003368","charu.paliwal@finddx.org",{"type":19,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100517554","evaluating-next-generation-lam-assays-and-molecular-diagnostics-poc-and-near-poc-for-the-diagnosis-of-tb-among-people-with-presumptive-tb-a-prospective-multicentre-diagnostic-accuracy-study-100517554",false,"NCT06019052","Evaluating Next Generation LAM Assays and Molecular Diagnostics (POC and Near POC) for the Diagnosis of TB Among People With Presumptive TB: a Prospective Multicentre Diagnostic Accuracy Study","Testing New Diagnostic Technology Classes for TB (DriveDx4TB)","DriveDx4TB","Inclusion Criteria:\n\n* Adult (≥18 years), with presumptive pulmonary TB i.e., self-reporting cough ≥2 weeks and ≥1 other symptom typical of pulmonary TB\\*\n* Willing to provide written informed consent\n* Willing to provide sputum, and other samples (tongue swabs, urine)\n* Willingness to have a telephonic follow-up call 2-3 months post-enrolment\n* Documented HIV status and CD4 count within last 6 months, or if unavailable, then willing to undergo testing\n* fever, night sweats or unintended weight-loss\n\nExclusion Criteria:\n\n* Participants currently on anti-TB treatment \\*\n* Any anti-TB treatment or antibiotics not specifically used for TB treatment, but which have anti-TB activity, e.g., fluoroquinolones given for respiratory tract infection within 60 days prior to enrolment\n* Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment\n* Participants who have conditions or circumstances that preclude their participation, based on the judgement of the site investigator\n* Unable to produce at least 3ml of sputum \\* Participants starting anti-TB treatment at the time of enrolment will not be excluded from the study provided that all study specimens are collected before starting the 3rd dose of treatment.","ALL","18 Years",{"count":31,"type":32},1890,"ESTIMATED","OBSERVATIONAL","This prospective multicentre study is planned to evaluate the next generation LAM assays and molecular diagnostics (POC and near POC) among people with presumptive Tuberculosis. The DriveDx4TB study aims to generate evidence needed to accelerate the introduction of three new classes of TB diagnostics, complemented by alternative sampling for use at primary healthcare and community settings. To this end, the study will leverage the accelerated innovation spurred by the COVID-19 pandemic, particularly the rapid development of swab-based sampling and molecular diagnostic (MDx) platforms.",[36],"Tuberculosis",[38,39,40,41,42,43,44,45,46],"TB","Diagnostics","HIV","Diagnostic accuracy study","Alternative samples","Point of care (POC)","Near POC","Molecular diagnostic (MDx) platforms","Urine LAM","NOT_YET_RECRUITING","2025-06-18",{"date":50,"type":51},"2025-06-24","ACTUAL",{"date":53,"type":32},"2025-09",{"date":55,"type":32},"2026-12",{"name":5,"class":6}]