[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522425":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":168,"collaborators":171,"id":175,"slug":176,"hasResults":177,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":11,"eligibilityCriteria":180,"healthyVolunteers":177,"sex":181,"minAge":11,"maxAge":182,"enrollmentInfo":183,"targetDuration":11,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":11,"overallStatus":42,"whyStopped":11,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Molecular testing for detection of T. pallidum and use of CDC guidelines for diagnosis of syphilis","EXPERIMENTAL",null,[13,14,15],"Diagnostic Test: Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum","Diagnostic Test: Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum","Other: Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis",[17,22,26],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"DIAGNOSTIC_TEST","Quantitative polymerase chain reaction (qPCR) assay for detection of Treponema pallidum","A quantitative polymerase chain reaction (qPCR) assay detects and quantifies DNA in a sample, and the qPCR assay used in this study targets the polA gene of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother\u002Fnewborn dyad at the time of birth. qPCR data will only be used to determine testing performance and will not be used in clinical management of study participants.",[9],{"type":18,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"Aptima Treponema pallidum transcription-mediated amplification (TMA) assay for detection of Treponema pallidum","The Aptima transcription-mediated amplification (TMA) assay used in this study will target RNA of T. pallidum to confirm presence of T. pallidum in a sample. Samples will be collected from the mother\u002Fnewborn dyad at the time of birth. TMA data will only be used to determine testing performance and will not be used in clinical management of study participants.",[9],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines for diagnosis of syphilis","Using the Center for Disease Control (CDC) Sexually Transmitted Infections (STI) 2021 Treatment Guidelines, new born syphilis infection is categorized by clinical providers at birth as follows: confirmed proven\u002Fhighly probably, possible congenital syphilis (CS), CS less likely, or CS unlikely. These CS categories are determined using neonatal nontreponemal test results, physical exam of the infant, placental pathology, and maternal serologies and treatment history, and comparison of maternal and neonatal nontreponemal tiers. These data will be collected as part of standard clinical care.",[9],[31],{"name":32,"affiliation":5,"role":33},"Irene Stafford, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":11,"email":38},"CONTACT","(713) 500-6412","Irene.Stafford@uth.tmc.edu",[40,63,74,93,103,118,137,147,157],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Southern California","RECRUITING","Los Angeles","California","90007","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-118.24368,34.05223,{"lat":52,"lon":51},[55,59],{"name":56,"role":36,"phone":57,"phoneExt":11,"email":58},"Brendan Grubbs, MD","323-361-6078","Brendan.grubbs@med.usc.edu",{"name":60,"role":36,"phone":61,"phoneExt":11,"email":62},"Alice Stek, MD","323-226-3353","stek@usc.edu",{"facility":64,"status":42,"city":43,"state":44,"zip":65,"country":46,"countryCode":47,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"University of California, Los Angeles","90095",{"type":49,"coordinates":67},[51,52],{"lat":52,"lon":51},[70],{"name":71,"role":36,"phone":72,"phoneExt":11,"email":73},"Karin Best, PhD","310-267-1908","kbest@mednet.ucla.edu",{"facility":75,"status":42,"city":76,"state":77,"zip":78,"country":46,"countryCode":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Johns Hopkins University","Baltimore","Maryland","21205",{"type":49,"coordinates":80},[81,82],-76.61219,39.29038,{"lat":82,"lon":81},[85,89],{"name":86,"role":36,"phone":87,"phoneExt":11,"email":88},"Jeanne Sheffield, MD","443-997-0400","jsheffi2@jhmi.edu",{"name":90,"role":36,"phone":91,"phoneExt":11,"email":92},"Chris Golden, MD","410-995-5259","cgolden@jhmi.edu",{"facility":94,"status":42,"city":76,"state":77,"zip":78,"country":46,"countryCode":47,"cosmosGeoPoint":95,"geoPoint":97,"contacts":98},"Kennedy Krieger Institute",{"type":49,"coordinates":96},[81,82],{"lat":82,"lon":81},[99],{"name":100,"role":36,"phone":101,"phoneExt":11,"email":102},"Alison Pritchard, PhD","443-923-9200","pritchard@kennedykrieger.org",{"facility":104,"status":42,"city":105,"state":106,"zip":107,"country":46,"countryCode":47,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":49,"coordinates":109},[110,111],-82.99879,39.96118,{"lat":111,"lon":110},[114],{"name":115,"role":36,"phone":116,"phoneExt":11,"email":117},"Pablo Sanchez","614-722-4559","pablo.sanchez@nationwidechildrens.org",{"facility":119,"status":42,"city":120,"state":121,"zip":122,"country":46,"countryCode":47,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Baylor College of Medicine","Houston","Texas","77030",{"type":49,"coordinates":124},[125,126],-95.36327,29.76328,{"lat":126,"lon":125},[129,133],{"name":130,"role":36,"phone":131,"phoneExt":11,"email":132},"Martha Rac, MD","832-826-7500","martha.rac@bcm.edu",{"name":134,"role":36,"phone":135,"phoneExt":11,"email":136},"Ryan Rochat, MD, PhD","936-262-0726","rochat@bcm.edu",{"facility":138,"status":42,"city":120,"state":121,"zip":122,"country":46,"countryCode":47,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"Texas Children's Hospital",{"type":49,"coordinates":140},[125,126],{"lat":126,"lon":125},[143],{"name":144,"role":36,"phone":145,"phoneExt":11,"email":146},"Lisa Noll, PhD","832-822-3700","lmnoll@texaschildrens.org",{"facility":148,"status":42,"city":120,"state":121,"zip":122,"country":46,"countryCode":47,"cosmosGeoPoint":149,"geoPoint":151,"contacts":152},"The University of Texas Health Science Center at Houston",{"type":49,"coordinates":150},[125,126],{"lat":126,"lon":125},[153],{"name":154,"role":36,"phone":155,"phoneExt":11,"email":156},"Norma Perez, DO","832-325-6516","norma.perez@uth.tmc.edu",{"facility":158,"status":42,"city":120,"state":121,"zip":159,"country":46,"countryCode":47,"cosmosGeoPoint":160,"geoPoint":162,"contacts":163},"Christus Health","78130",{"type":49,"coordinates":161},[125,126],{"lat":126,"lon":125},[164],{"name":165,"role":36,"phone":166,"phoneExt":11,"email":167},"James Hill, MD","210-704-3200","james.hill2@christushealth.org",{"type":33,"investigatorFullName":169,"investigatorTitle":170,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Irene Stafford","Associate Professor",[172],{"name":173,"class":174},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100522425","modernizing-perinatal-syphilis-testing-100522425",false,"NCT06082453","Modernizing Perinatal Syphilis Testing","Inclusion Criteria:\n\n* Maternal diagnosis of syphilis by 2021 CDC STI guidelines, irrespective of treatment status; AND viable pregnancy with gestational age ≥ 12 weeks OR postpartum ≤ 96 hours from delivery OR Neonates of pregnancies affected by syphilis ≤ 72 hours of birth\n* Individuals (men and non-pregnant) with syphilis in Harris Health clinic with syphilis\n\nExclusion Criteria:\n\n* Pregnant individuals and neonates who do not meet the criteria of syphilis (false positive)\n* Planning to move outside of study prior to ND testing","ALL","45 Years",{"count":184,"type":185},924,"ESTIMATED","INTERVENTIONAL",[188],"NA","The purpose of this study is to determine the testing performance of real-time quantitative polymerase chain reaction and transcription mediated amplification by comparing test performance of these novel molecular tests to current 2021 CDC CS guidelines for maternal\u002Fneonatal dyads at risk for syphilis infection and to determine whether CS is associated with adverse neurodevelopmental outcomes.",[191],"Syphilis","2025-10-30",{"date":194,"type":195},"2025-11-03","ACTUAL",{"date":197,"type":195},"2023-05-02",{"date":199,"type":185},"2027-11-30",{"name":5,"class":6},9]