[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524832":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":10,"centralContacts":57,"locations":63,"responsibleParty":85,"collaborators":89,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":10,"eligibilityCriteria":101,"healthyVolunteers":98,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":103,"studyType":108,"phases":10,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Tulane University","OTHER",[8,19,23,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Presumptive pediatric TB cases-- Test population",null,"Inclusion criteria: Children ages 2 months to 14 years with symptomatic disease and suspicion of TB (based on Bolivian Ministry of Health guidelines).\n\nExclusion criteria (prior treatment for TB in 12 mo, current treatment for TB, weight \\\u003C 2.5 kg., instability, positive COVID-19 test) Study subgroups are determined in part based on the results of diagnostic tests and on clinical response.\n\nA. Confirmed TB\n\n* Symptomatic by case definition from the 2015 NIH Expert Panel\n* Positive culture or positive Xpert MTB\u002FRIF from at least one sample.\n\nB. Unconfirmed TB-\n\n* Symptomatic and clinical\u002Fradiographic evaluation consistent with TB, by case definition from the 2015 NIH Expert Panel\n* Negative M. tuberculosis culture and negative Xpert MTB\u002FRIF from all samples.\n\nC. Unlikely TB---\n\n* Symptomatic BUT clinical\u002Fradiographic eval does NOT meet criteria for Unconfirmed TB, per clinical definition-2015 Expert Panel\n* Negative culture and negative Xpert MTB\u002FRIF from all specimens.",[13,14,15,16,17,18],"Diagnostic Test: Quantiferon Gold","Diagnostic Test: HIV serology","Diagnostic Test: Respiratory secretion culture (sputum or gastric aspirate_","Diagnostic Test: Chest radiograph","Diagnostic Test: Lung ultrasound","Diagnostic Test: cell free DNA test",{"label":20,"type":10,"description":21,"interventionNames":22},"Control group--Test population","Well Children Control Group-One for each child in groups A-C above, age matched for paired case.\n\n* Well children presenting for reasons other than respiratory diseases, and not symptomatic for TB.\n* Clinical and radiographic evaluation (if performed) NOT suggestive of TB, and NOT diagnosed or treated for TB during the follow-up period (minimum 8 weeks).\n* Divided into 2 subgroups based on presence or absence of LTBI (by Quantiferon Gold assay).",[13,14,18],{"label":24,"type":10,"description":11,"interventionNames":25},"Presumptive pediatric TB cases-- Validation population",[13,14,15,16,17,18],{"label":27,"type":10,"description":21,"interventionNames":28},"Control group--Validation population",[13,14,18],[30,35,39,43,49,53],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":10},"DIAGNOSTIC_TEST","Quantiferon Gold","Test for TB infection",[20,27,9,24],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":10},"HIV serology","Test for HIV infection",[20,27,9,24],{"type":31,"name":40,"description":41,"armGroupLabels":42,"otherNames":10},"Respiratory secretion culture (sputum or gastric aspirate_","TB culture by MODS",[9,24],{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Chest radiograph","Chest imaging test by traditional X ray",[9,24],[48],"Chest X ray",{"type":31,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"Lung ultrasound","Chest imaging test by ultrasound",[9,24],{"type":31,"name":54,"description":55,"armGroupLabels":56,"otherNames":10},"cell free DNA test","Blood test for TB infection",[20,27,9,24],[58],{"name":59,"role":60,"phone":61,"phoneExt":10,"email":62},"Richard Oberhelman, MD","CONTACT","001-504-952-0964","oberhel@tulane.edu",[64],{"facility":65,"status":66,"city":67,"state":10,"zip":10,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Hospital de Ninos \"Mario Ortiz Suarez\"","RECRUITING","Santa Cruz","Bolivia","BO",{"type":71,"coordinates":72},"Point",[73,74],-65.31667,-21.75,{"lat":74,"lon":73},[77,81],{"name":78,"role":60,"phone":79,"phoneExt":10,"email":80},"Shirley Equilia","+591-7362-9688","equilia.skeb@gmail.com",{"name":82,"role":60,"phone":83,"phoneExt":10,"email":84},"Freddy Tinajeros, PhD","+591-7098-2086","ftinajeros@gmail.com",{"type":86,"investigatorFullName":87,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Richard A. Oberhelman","Professor",[90,92,94],{"name":91,"class":6},"Asociacion Benefica Prisma",{"name":93,"class":6},"Universidad Peruana Cayetano Heredia",{"name":95,"class":6},"Johns Hopkins Bloomberg School of Public Health","100524832","diagnostic-innovations-for-pediatric-tuberculosis-in-bolivia-100524832",false,"NCT06113861","Diagnostic Innovations for Pediatric Tuberculosis in Bolivia","Inclusion Criteria:\n\n* Children presenting for evaluation for symptomatic respiratory disease and suspicion of tuberculosis will be eligible for enrollment (inclusion criteria based on Bolivian Ministry of Health guidelines for suspect cases of tuberculosis in children\n\nExclusion Criteria:\n\n* prior treatment for TB within the past year,\n* current treatment for prevention of TB,\n* weight \\\u003C 2.5 kg., or\n* clinical instability,\n* positive COVID-19 diagnostic test","ALL","2 Months","14 Years",{"count":106,"type":107},1220,"ESTIMATED","OBSERVATIONAL","Pediatric tuberculosis (TB) continues to pose diagnostic challenges in low- and middle-income countries with high rates of TB disease, due to the well-described impact of paucibacillary disease in children, and current TB culture and polymerase-chain reaction tests are of limited usefulness due to cost, restricted availability, and poor sensitivity in specimens available from younger children. Our team of experts from Tulane, Johns Hopkins University, Universidad Peruana Cayetano Heredia, and Asociación Benéfica Prisma have confronted all of these challenges through more than 25 years of collaboration in Peru and Bolivia. Our goal is to directly address the challenges of TB in children by evaluating a new diagnostic approach developed by MPI Tony Hu at Tulane University using a CRISPR-mediated TB assay (CRISPR-TB) optimized to detect circulating Mycobacterium tuberculosis cell-free DNA (Mtb-cfDNA), and used to analyze cryopreserved serum in pilot studies from adults and children with presumptive TB, their asymptomatic household contacts, and a cohort of symptomatic children living with HIV (CLHIV) at high risk for TB. Results from symptomatic adult cohorts yielded a pooled sensitivity of 93%; specificity of 93%; positive predictive value of 95%; and negative predictive value of 92%. In limited pilot studies in CLHIV CRISPR-TBD results accurately identified all confirmed TB (13\u002F13) and most children with unconfirmed TB (80%; 52\u002F65). We propose to enroll 200 presumptive TB cases and an equal number of well control subjects in each of 2 study populations (test population and validation population) identified through clinics associated with the \"Dr. Mario Ortiz Suarez\" Children's Hospital in Santa Cruz, Bolivia. We will determine the distribution of cfDNA concentrations in peripheral blood in a \"test population\" composed of two age-based groups of children (2 months-6 years, 7-14 years) with respiratory disease grouped by likelihood of TB based on the NIH consensus case definitions (confirmed TB, unconfirmed TB, and unlikely TB) and in age-matched controls grouped by presence of latent TB infection (LTBI), with cfDNA measured serially in time among TB cases receiving antibiotic therapy. We will also validate standard ranges of quantitative cfDNA established for clinical subgroups of children with TB disease or LTBI in an independent validation cohort. An additional aim will determine the correlation between quantitative cfDNA and quantitative imaging-based TB scores based on evidence of disease in the lung, the primary target organ in TB disease, by (1) chest radiograph, measured by computer-aided analysis using the CAD4TB v7 system, and by (2) lung ultrasound, performed with a portable\u002Flow-cost probe assisted by machine learning algorithms for automatic interpretation. These biomarkers will be tested as potential cofactors that may be combined with cfDNA levels in peripheral blood, to improve the detection of TB disease in children. The results of this study will be the first step in a process to find a path to allow detection of the many \"unconfirmed\" TB cases and ideally make the diagnosis of pediatric TB in reach for low resource settings where it is so critically needed.",[111],"Tuberculosis",[113,114,115],"Diagnostic testing","Children","Imaging analysis","2025-09-03",{"date":118,"type":119},"2025-09-05","ACTUAL",{"date":121,"type":119},"2024-04-15",{"date":123,"type":107},"2028-10",{"name":5,"class":6},1]