[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Foundation for Innovative New Diagnostics, Switzerland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":91},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,36,59],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":25,"lastUpdatePostDateStruct":26,"startDateStruct":29,"completionDateStruct":31,"leadSponsor":33,"locationsCount":4},"100637081","performance-evaluation-of-mpox-molecular-poc-diagnostics-100637081",false,"NCT07620600","Performance Evaluation of Mpox Molecular POC Diagnostics","Clinical Performance Evaluation of Novel Rapid Molecular Point-of-care (POC) Diagnostics for Mpox Virus","Inclusion Criteria:\n\n* Lesion swabs stored in VTM\u002FUTM (non-inactivating)\n* Aliquot with sufficient volume to run the reference PCR and at least one index test (≥2600 μL per pair reference-index tests: ideally at least 1400 μL for 3 index tests and 1200 μL for reference PCR, including 1 possible repeat per test)\n* Available PCR result for specimen selection (i.e. confirmed MPXV positive or negative)\n* Samples collected from 2020 onwards.\n\nExclusion Criteria:\n\n* Unknown date of collection\n* \\>3 freeze-thaw cycles of sample.\n* Samples collected with expired swab collection devices or UTM\u002FVTM","ALL",{"count":18,"type":19},80,"ESTIMATED","OBSERVATIONAL","PP016 is a FIND-sponsored retrospective clinical performance study evaluating rapid molecular point-of-care (mPOC) tests for the detection of Mpox virus (MPXV) using archived lesion swab specimens collected in Uganda. Conducted at the Central Public Health Laboratory (CPHL) in Kampala, the study compares up to three investigational assays-Genes2Me VZV-Q, KH Medical RADI-ONE Mpox, and SD Biosensor STANDARD M10 MPX\u002FOPX-against the BioPerfectus laboratory PCR reference test. The primary objective is to determine the sensitivity and specificity of each assay for detecting MPXV in archived positive and negative samples, while secondary analyses assess performance by Ct value and viral clade. The study uses a blinded, non-interventional case-control design with de-identified specimens collected since 2020. Approximately 80 samples per device evaluation are included. PP016 was initiated in response to ongoing mpox outbreaks and the need for accurate decentralized diagnostics in low-resource settings. The study complies with ISO 20916, ICH-GCP principles where applicable, and Ugandan ethical and regulatory requirements, with findings expected to support future regulatory approvals and implementation of rapid mpox diagnostics in low- and middle-income countries",[23],"Monkey Pox","NOT_YET_RECRUITING","2026-05-27",{"date":27,"type":28},"2026-06-02","ACTUAL",{"date":30,"type":19},"2026-06-15",{"date":32,"type":19},"2026-09-15",{"name":34,"class":35},"Foundation for Innovative New Diagnostics, Switzerland","OTHER",{"id":37,"slug":38,"hasResults":11,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":4,"eligibilityCriteria":42,"healthyVolunteers":43,"sex":16,"minAge":44,"maxAge":4,"enrollmentInfo":45,"targetDuration":47,"studyType":20,"phases":4,"briefSummary":48,"conditions":49,"keywords":4,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":4},"100628079","non-invasive-malaria-diagnostic-data-collection-in-ethiopia-100628079","NCT07456969","Non-invasive Malaria Diagnostic Data Collection in Ethiopia","Data Collection Support for a Non-invasive Malaria Diagnostic Tool Using Volatile Organic Compounds (VOC) in Gondar, Ethiopia","Inclusion Criteria:\n\nAged 12 years or older\n\nPresenting at the study site with fever (37.5 degrees and above)\n\nFreely agreeing to participate by providing informed consent (and assent, if applicable)\n\nExclusion Criteria:\n\nPresence of symptoms and signs of severe illness and\u002For central nervous system infections.\n\nPresenting with any condition that prevents adequate breath collection:\n\nAsthma\n\nChronic Obstructive Pulmonary Disease (COPD)\n\nSevere respiratory illness\n\nInability to follow instructions\n\nPatient lacking capacity to provide informed consent.\n\nPrior antimalarial treatment within the last 14 days.",true,"12 Years",{"count":46,"type":19},200,"1 Day","This project supports the development of a non-invasive diagnostic tool for malaria, focusing on validating the link between VOCs (volatile organic compounds) and malaria infection using thermodynamic sensors. This technology aims to provide rapid, painless alternatives to blood-based diagnostics, enabling malaria detection without invasive sampling.\n\nTrace Sensing has already identified six potential VOC biomarkers based on published literature specific for malaria. Two of these are part of the company's existing library and can already be detected in purified form by the TRACE-E device, while the others are under active evaluation. To confirm the suitability of the selected VOC biomarkers for diagnosing malaria and strengthen the detection algorithm, high-quality, robust clinical data from well-characterized biological specimens are required. In partnership with Gondar University in Ethiopia, breath samples will be collected from individuals (12 years and older) suspected of having malaria presenting at two health clinics. PCR performed on blood samples will serve as reference method to confirm infection status, while non-invasive clinical breath tests will be performed using the TRACE-E device.\n\nThe resulting data will confirm whether the six candidate malaria VOC biomarkers can be detected in patient breath, and if other VOC biomarkers can be detected as well. This study will therefore act as a malaria VOC biomarker confirmation study.",[50],"Malaria Fever","2026-03-03",{"date":53,"type":28},"2026-03-09",{"date":55,"type":19},"2026-04",{"date":57,"type":19},"2026-09",{"name":34,"class":35},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":24,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":4},"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","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.","18 Years",{"count":69,"type":19},1890,"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.",[72],"Tuberculosis",[74,75,76,77,78,79,80,81,82],"TB","Diagnostics","HIV","Diagnostic accuracy study","Alternative samples","Point of care (POC)","Near POC","Molecular diagnostic (MDx) platforms","Urine LAM","2025-06-18",{"date":85,"type":28},"2025-06-24",{"date":87,"type":19},"2025-09",{"date":89,"type":19},"2026-12",{"name":34,"class":35},""]