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Satlin, MD, MS","Weill Medical College of Cornell University","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":39},"Jeffrey D. Klausner, MD, MPH","University of Southern California - Los Angeles",{"name":44,"affiliation":5,"role":45},"Vance G. Fowler, MD, MHS","STUDY_DIRECTOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},"Nyssa Schwager, MSN, RN","CONTACT","708-217-1146","nyssa.schwager@duke.edu",{"name":37,"role":49,"phone":53,"phoneExt":10,"email":54},"434-531-6218","mjs9012@med.cornell.edu",[56,80,101,121,145,166,187,210],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"San Francisco Public Health Laboratory","RECRUITING","San Francisco","California","94102","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-122.41942,37.77493,{"lat":68,"lon":67},[71,75,78],{"name":72,"role":49,"phone":73,"phoneExt":10,"email":74},"Lina Castro, PHM, MPH, M(ASCP)CM, TS (ABB)","415-554-2800","lina.castro@sfdph.org",{"name":76,"role":49,"phone":73,"phoneExt":10,"email":77},"John Lei, Virology Supervisor","john.lei@sfdph.org",{"name":79,"role":39,"phone":10,"phoneExt":10,"email":10},"Godfred Masinde, Laboratory 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Roberts","601-576-7973","whitney.roberts@msdh.ms.gov",{"name":117,"role":49,"phone":114,"phoneExt":10,"email":118},"Terrika Flowers","terrika.flowers1@msdh.ms.gov",{"name":120,"role":39,"phone":10,"phoneExt":10,"email":10},"Anna Scasny",{"facility":122,"status":58,"city":123,"state":124,"zip":125,"country":62,"countryCode":63,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Corewell Health","Royal Oak","Missouri","48073",{"type":65,"coordinates":127},[128,129],-91.47236,36.73395,{"lat":129,"lon":128},[132,136,140,142],{"name":133,"role":49,"phone":134,"phoneExt":10,"email":135},"Maureen Cooney, RN, BSN, CCRP","248-551-0027","maureen.cooney@corewellhealth.org",{"name":137,"role":49,"phone":138,"phoneExt":10,"email":139},"Kimberly Powell","248-551-2685","kimberly.powell2@corewellhealth.org",{"name":141,"role":39,"phone":10,"phoneExt":10,"email":10},"Carmen Demarco, MD",{"name":143,"role":144,"phone":10,"phoneExt":10,"email":10},"Matthew Sims, MD PhD, FACP, 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MB(ASCP)","801-583-2787","jadyn.schoemaker@aruplab.com",{"name":182,"role":49,"phone":179,"phoneExt":183,"email":184},"Megan Hirschi, Research Manager","6252","megan.hirschiadamson@aruplab.com",{"name":186,"role":39,"phone":10,"phoneExt":10,"email":10},"Salika Shakir, Ph.D., D(ABMM)",{"facility":188,"status":58,"city":189,"state":190,"zip":191,"country":62,"countryCode":63,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"University of Virginia School of Medicine","Charlottesville","Virginia","22908",{"type":65,"coordinates":193},[194,195],-78.47668,38.02931,{"lat":195,"lon":194},[198,202,206,207,208],{"name":199,"role":49,"phone":200,"phoneExt":10,"email":201},"Melinda D Poulter, Ph.D., D (ABMM)","434-924-5667","mdp3s@uvahealth.org",{"name":203,"role":49,"phone":204,"phoneExt":10,"email":205},"Emily Snavely, Ph.D., D(ABMM)","434-243-7401","xjx4nh@uvahealth.org",{"name":199,"role":39,"phone":10,"phoneExt":10,"email":10},{"name":203,"role":144,"phone":10,"phoneExt":10,"email":10},{"name":209,"role":144,"phone":10,"phoneExt":10,"email":10},"Amy J Mathers, MD, D(ABMM)",{"facility":211,"status":58,"city":212,"state":213,"zip":214,"country":62,"countryCode":63,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Molecular Testing Labs","Vancouver","Washington","98684",{"type":65,"coordinates":216},[217,218],-122.66149,45.63873,{"lat":218,"lon":217},[221,225],{"name":222,"role":49,"phone":223,"phoneExt":10,"email":224},"Chris Hemphill","360-693-8850","chemphill@moleculartestinglabs.com",{"name":226,"role":39,"phone":10,"phoneExt":10,"email":10},"Charles Sailey",{"type":228,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[230,233,236,238],{"name":231,"class":232},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":234,"class":235},"SpeeDx Pty Ltd","INDUSTRY",{"name":237,"class":235},"Abbott",{"name":239,"class":240},"Seegene USA Inc","UNKNOWN","100578764","master-protocol-for-evaluating-multiple-infection-diagnostics-for-ciprofloxacin-resistant-neisseria-gonorrhoeae-100578764",false,"NCT06815536","Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae","MASTERMINDRING","Inclusion Criteria:\n\n* Be N. gonorrhoeae-positive on an FDA-cleared molecular assay\n* Have sufficient N. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing\n* Undergo proper handling and storage conditions\n\nExclusion Criteria:\n\n* The N. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site\n* The N. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source","ALL",{"count":250,"type":251},3291,"ESTIMATED","OBSERVATIONAL","The goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyrA 91F) that predicts ciprofloxacin resistance in clinical specimens that harbor Neisseria gonorrhoeae. The main question the study aims to answer:\n\nCan the investigational reflex test find the correct gene mutation (Neisseria gonorrhoeae gyrA 91F or gyrA 91S) as compared to the sequenced result?\n\nSpecimens that are collected for routine clinical care and harbor Neisseria gonorrhoeae will be evaluated in this study.",[255],"Neisseria Gonorrheae Infection",[257,258,259],"mutant allele gyrA 91F","wildtype allele gyrA 91S","ciprofloxacin-resistant Neisseria gonorrhoeae","2026-03-04",{"date":262,"type":263},"2026-03-05","ACTUAL",{"date":265,"type":263},"2025-04-16",{"date":267,"type":251},"2026-07",{"name":5,"class":6},8]