[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515307":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":38,"centralContacts":46,"locations":55,"responsibleParty":101,"collaborators":103,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":23,"eligibilityCriteria":125,"healthyVolunteers":126,"sex":127,"minAge":23,"maxAge":128,"enrollmentInfo":129,"targetDuration":23,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":23,"overallStatus":58,"whyStopped":23,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Evaluation of various novel TB triage and diagnostic tests","EXPERIMENTAL","The investigators will conduct evaluation of novel TB triage and diagnostic tests in a cohort of children with presumed TB. The investigators aim to enroll 250 participants per year at each of three enrollment sites for evaluation of various novel TB triage and diagnostic tests and 30 health workers to assess test usability. Novel test evaluations will be conducted on a rolling basis as new tests ready for field evaluation are identified.",[13,14,15,16],"Diagnostic Test: Oral swab molecular testing","Diagnostic Test: Automated Cough Sound Analysis","Diagnostic Test: Automated Lung Sound Analysis","Other: Chest X Ray Computer Aided Detection",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DIAGNOSTIC_TEST","Oral swab molecular testing","Swab-based testing provides a non-invasive approach to collect respiratory specimens for TB testing. Data in adults suggests that swab-based testing could be valuable when sputum collection is not feasible or available.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Automated Cough Sound Analysis","Cough sounds can be collected through a mobile phone and tablet, and then analyzed with machine learning algorithms to predict TB.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Automated Lung Sound Analysis","Lung sounds can be collected with a non-invasive digital stethoscope, and then saved on a tablet or phone and analyzed by machine learning algorithms to predict TB.",[9],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Chest X Ray Computer Aided Detection","Several artificial intelligence algorithms have been developed to predict TB, though this has not yet been validated in children.",[9],[37],"Artificial Intelligence algorithm",[39,43],{"name":40,"affiliation":41,"role":42},"Adithya Cattamanchi, MD, MAS","University of California, Irvine","PRINCIPAL_INVESTIGATOR",{"name":44,"affiliation":45,"role":42},"Nilesh Bhatt","Elizabeth Glazer Pediatric AIDS Foundation",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":23,"email":51},"Devan Jaganath, MD","CONTACT","415-514-4692","devan.jaganath@ucsf.edu",{"name":53,"role":49,"phone":23,"phoneExt":23,"email":54},"Brittney Sweetser, MPH","bsweetse@hs.uci.edu",[56,72,87],{"facility":57,"status":58,"city":59,"state":23,"zip":23,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Instituto Nacional de Saúde","RECRUITING","Maputo","Mozambique","MZ",{"type":63,"coordinates":64},"Point",[65,66],32.58322,-25.96553,{"lat":66,"lon":65},[69],{"name":70,"role":49,"phone":23,"phoneExt":23,"email":71},"Celso Khosa","celso.khosa@ins.gov.mz",{"facility":73,"status":74,"city":75,"state":23,"zip":23,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Dora Nginza Hospital","NOT_YET_RECRUITING","Cape Town","South Africa","ZA",{"type":63,"coordinates":79},[80,81],18.42322,-33.92584,{"lat":81,"lon":80},[84],{"name":85,"role":49,"phone":23,"phoneExt":23,"email":86},"Heather Zar","heather.zar@uct.ac.za",{"facility":88,"status":74,"city":89,"state":23,"zip":23,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Mulago National Referral Hospital","Kampala","Uganda","UG",{"type":63,"coordinates":93},[94,95],32.58219,0.31628,{"lat":95,"lon":94},[98],{"name":99,"role":49,"phone":23,"phoneExt":23,"email":100},"Eric Wobudeya","ewobudeya@mujhu.org",{"type":102,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[104,107,109,111,113,115,118],{"name":105,"class":106},"Instituto Nacional de Saúde, Mozambique","OTHER_GOV",{"name":108,"class":106},"National Referral Hospital",{"name":110,"class":6},"University of Cape Town",{"name":112,"class":6},"Johns Hopkins University",{"name":114,"class":6},"Elizabeth Glaser Pediatric AIDS Foundation",{"name":116,"class":117},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":41,"class":6},"100515307","rapid-research-in-diagnostics-development-for-tb-network-r2d2-kids-and-assessing-diagnostics-at-poc-for-tb-in-children-adapt-for-kids-100515307",false,"NCT05989802","Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and Assessing Diagnostics At POC for TB in Children (ADAPT for Kids)","Rapid Research in Diagnostics Development for Tuberculosis Network (R2D2 Kids) and Assessing Diagnostics At Point-of-care for Tuberculosis in Children (ADAPT for Kids)","Participant eligibility criteria:\n\nParticipants will include children (age \\\u003C15 years) who present to care with:\n\nA. 2 or more of the following:\n\n* Unexplained cough for any duration\n* TB contact or tuberculin skin test or interferon gamma release assay positive\n* Abnormal chest X-ray (any abnormality) OR\n\nB. Any one of criteria A AND any one of the following:\n\n* Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition\n* Unexplained fever ≥2 weeks\n* Unexplained lethargy or reduced playfulness ≥2 weeks\n\nThe study will exclude participants who:\n\n1. Completed preventive or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);\n2. Have taken any medication with anti-mycobacterial activity for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives);\n3. Are unable to return for follow-up visits; or\n4. Whose parents\u002Fguardians are unwilling to provide informed consent or who are unwilling to provide assent if applicable (age determined by local IRB)\n\nAssessment of the usability of novel TB tests:\n\nThe study will also include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). Personnel who are unwilling to provide informed consent will be excluded.",true,"ALL","65 Years",{"count":130,"type":131},2100,"ESTIMATED","INTERVENTIONAL",[134],"NA","Every year there are an estimated 230,000 childhood deaths from TB. There is an urgent need for novel tests for TB diagnosis in children under 15 years. The Rapid Research in Diagnostics Development for TB Network (R2D2 Kids) and the Assessing Diagnostics at Point-of-care for Tuberculosis in children (ADAPT for Kids) studies seek to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests for use in children.",[137,138,139],"Tuberculosis","Diagnostics","Global Health","2026-03-09",{"date":142,"type":143},"2026-03-11","ACTUAL",{"date":145,"type":143},"2024-01-26",{"date":147,"type":131},"2026-09-01",{"name":5,"class":6},3]