[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644546":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":47,"centralContacts":52,"locations":63,"responsibleParty":240,"collaborators":57,"id":242,"slug":243,"hasResults":244,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":57,"eligibilityCriteria":248,"healthyVolunteers":244,"sex":249,"minAge":250,"maxAge":251,"enrollmentInfo":252,"targetDuration":57,"studyType":255,"phases":256,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":266,"whyStopped":57,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"Global Alliance for TB Drug Development","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Sorfequline 200\u002F100-Pretomanid 200mg-Linezolid 600mg (Loading Dose)","EXPERIMENTAL","Regimen (17 weeks total):\n\nWeeks 1-4: Sorfequiline 200 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Weeks 5-17: Sorfequiline 100 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily",[13,14,15],"Drug: sorfequiline","Drug: Pretomanid","Drug: Linezolid",{"label":17,"type":10,"description":18,"interventionNames":19},"Sorfequiline 100-Pretomanid 200mg-Linezolid 600mg (No Loading Dose)","Regimen (17 weeks total):\n\nWeeks 1-17: Sorfequiline 100 mg + Pretomanid 200 mg + Linezolid 600 mg, once daily Includes sorfequiline placebo tablets during first 4weeks to maintain blinding vs the loading regimen.",[13,14,15],[21,29,37],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","sorfequiline","Two sorfequiline 100mg tablets taken once daily for 4 weeks then one sorfequiline taken once daily for 13 weeks OR one sorfequiline 100mg tablet taken once daily for 17 weeks (with one 100mg sorfequiline placebo tablet for the first 4 weeks)",[17,9],[27,28],"TBAJ876","S",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Pretomanid","one 200mg tablet taken once daily for 17 weeks",[17,9],[34,35,36],"PA-824","P","Dovprela",{"type":22,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Linezolid","one 600mg tablet taken once daily for 17 weeks",[17,9],[42,43,44,45,46],"L","Zyvox","Linospan","Linosept","Lizolid",[48],{"name":49,"affiliation":50,"role":51},"Morounfolu Olugbosi","TB Alliance","STUDY_DIRECTOR",[53,59],{"name":54,"role":55,"phone":56,"phoneExt":57,"email":58},"Leandra Lombard","CONTACT","+27 83 30 76784",null,"leandra.lombard@tballiance.org",{"name":60,"role":55,"phone":61,"phoneExt":57,"email":62},"Morounfolu Olugbosi, MD","+27 79 045 4917","morounfolu.olugbosi@tballiance.org",[64,84,101,118,135,151,167,183,198,212,226],{"facility":65,"status":57,"city":66,"state":67,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Isango Lethemba TB Research Unit","Port Elizabeth","Bethelsdorp","6200","South Africa","ZA",{"type":72,"coordinates":73},"Point",[74,75],25.61494,-33.96109,{"lat":75,"lon":74},[78,82],{"name":79,"role":55,"phone":80,"phoneExt":57,"email":81},"Simone Faesen, MD","+27 41 492 3195","SimFaesen@witshealth.co.za",{"name":79,"role":83,"phone":57,"phoneExt":57,"email":57},"PRINCIPAL_INVESTIGATOR",{"facility":85,"status":57,"city":86,"state":87,"zip":88,"country":69,"countryCode":70,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Setshaba Research Centre","Pretoria","Guateng","0152",{"type":72,"coordinates":90},[91,92],28.18783,-25.74486,{"lat":92,"lon":91},[95,99],{"name":96,"role":55,"phone":97,"phoneExt":57,"email":98},"Zinhie Zwane, MD","+27 12 799 2422","Zzwane@setshabe.org.za",{"name":100,"role":83,"phone":57,"phoneExt":57,"email":57},"Zinhle Zwane, MD",{"facility":102,"status":57,"city":103,"state":104,"zip":105,"country":69,"countryCode":70,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"University of Capetown Lung Institute","Cape Town","Mowbray","7700",{"type":72,"coordinates":107},[108,109],18.42322,-33.92584,{"lat":109,"lon":108},[112,116],{"name":113,"role":55,"phone":114,"phoneExt":57,"email":115},"Sherman PadayaChee, MD","+27 21 404 7747","Sherman.Padayachee@uct.ac.za",{"name":117,"role":83,"phone":57,"phoneExt":57,"email":57},"Sherman Padayachee, MD",{"facility":119,"status":57,"city":120,"state":121,"zip":122,"country":69,"countryCode":70,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"The Aurum Institute, Rustenburg","Rustenburg","North West","2999",{"type":72,"coordinates":124},[125,126],27.24208,-25.66756,{"lat":126,"lon":125},[129,131,134],{"name":130,"role":55,"phone":57,"phoneExt":57,"email":57},"William Brumskine, MD",{"name":130,"role":55,"phone":132,"phoneExt":57,"email":133},"+27 87 135 1575","wbrumskine@auruminstitute.org",{"name":130,"role":83,"phone":57,"phoneExt":57,"email":57},{"facility":136,"status":57,"city":137,"state":138,"zip":139,"country":69,"countryCode":70,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Madiberg Centre for Research","Brits","North West Provinvce","0250",{"type":72,"coordinates":141},[142,143],27.78022,-25.63473,{"lat":143,"lon":142},[146,150],{"name":147,"role":55,"phone":148,"phoneExt":57,"email":149},"Lindsey Faul, MD","+27 12 252 1140","lfaul@madibengresearch.co.za",{"name":147,"role":83,"phone":57,"phoneExt":57,"email":57},{"facility":152,"status":57,"city":153,"state":154,"zip":155,"country":69,"countryCode":70,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Durban International Clinical Research Site, Enhancing Care Foundation","Durban","Wentworth","4052",{"type":72,"coordinates":157},[158,159],31.0292,-29.8579,{"lat":159,"lon":158},[162,166],{"name":163,"role":55,"phone":164,"phoneExt":57,"email":165},"Umesh Lalloo, MD","+ 27 31 261 1093\u002F5","lalloo@ecarefoundation.com",{"name":163,"role":83,"phone":57,"phoneExt":57,"email":57},{"facility":168,"status":57,"city":169,"state":57,"zip":170,"country":69,"countryCode":70,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Synergy Biomed Research Institute","East London","5201",{"type":72,"coordinates":172},[173,174],27.91162,-33.01529,{"lat":174,"lon":173},[177,181],{"name":178,"role":55,"phone":179,"phoneExt":57,"email":180},"Mookho Mallahleha, MD","+27 34 722 2306","drmookho@sbri.org.za",{"name":182,"role":83,"phone":57,"phoneExt":57,"email":57},"Mookho Malahleha, MD",{"facility":184,"status":57,"city":185,"state":57,"zip":57,"country":186,"countryCode":57,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"INUKA Africa","Dar es Salaam","Tanzania",{"type":72,"coordinates":188},[189,190],39.26951,-6.82349,{"lat":190,"lon":189},[193,197],{"name":194,"role":55,"phone":195,"phoneExt":57,"email":196},"Frederik Haraka, MD","+255 22 270 0021\u002F4","fharaka@inuka-africa.org",{"name":194,"role":83,"phone":57,"phoneExt":57,"email":57},{"facility":199,"status":57,"city":200,"state":57,"zip":57,"country":186,"countryCode":57,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Mbeya Referral Hospital","Mbeya",{"type":72,"coordinates":202},[203,204],33.45,-8.9,{"lat":204,"lon":203},[207,211],{"name":208,"role":55,"phone":209,"phoneExt":57,"email":210},"Christina Manyama, MD","+255 25 250 3364","christina.manyama@nimr.or.tz",{"name":208,"role":83,"phone":57,"phoneExt":57,"email":57},{"facility":213,"status":57,"city":214,"state":57,"zip":57,"country":186,"countryCode":57,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Kilimanjaro Clinical Research Instuute","Moshi",{"type":72,"coordinates":216},[217,218],37.33333,-3.35,{"lat":218,"lon":217},[221,225],{"name":222,"role":55,"phone":223,"phoneExt":57,"email":224},"Blandina Mmbaga, MD","+255 27 275 4201","b.nmbaga@kcri.ac.tz",{"name":222,"role":83,"phone":57,"phoneExt":57,"email":57},{"facility":227,"status":57,"city":228,"state":57,"zip":57,"country":186,"countryCode":57,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"National Instittute for Medical Research","Mwanza",{"type":72,"coordinates":230},[231,232],32.9,-2.51667,{"lat":232,"lon":231},[235,239],{"name":236,"role":55,"phone":237,"phoneExt":57,"email":238},"Kidola Jeremiah, MD","+255 28 250 3012","kiddola.jeremiah@nimri.or..tz",{"name":236,"role":83,"phone":57,"phoneExt":57,"email":57},{"type":241,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100644546","phase-2-sorfequiline-based-regimens-in-adults-with-newly-diagnosed-drug-sensitive-pulmonary-tb-100644546",false,"NCT07672405","Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB","A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis","Inclusion Criteria:\n\n* DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB\n* Of non-childbearing potential OR using effective birth control methods\n* Body weight ≥ 35 k\n\nExclusion Criteria:\n\n* Karnofsky score \\\u003C 60 at screening\n* Any evidence of extrapulmonary TB\n* Cardiovascular or QT prolongation risk factors Pregnant or breast-feeding\n* Laboratory abnormalities as defined in the protocol. • For participants living with HIV only:\n\n  * CD4+ count\\\u003C200 cells\u002FμL.\n  * WHO Clinical Stage 4 HIV disease\n  * Participant does not agree to use DTG\u002FTFV\u002F3TC during study treatment if ARV therapy is indicated\n  * If initiation of ARV therapy is indicated, participants who are known to be intolerant, non-responsive to DTG\u002FTFV\u002F3TC or have DTG\u002FTFV\u002F3TC as a contraindication.","ALL","18 Years","65 Years",{"count":253,"type":254},100,"ESTIMATED","INTERVENTIONAL",[257],"PHASE2","The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200\u002F100SPaL-4\u002F13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis.\n\nParticipants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either :\n\n1. a sorfequiline loading-dose regimen (200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks) plus pretomanid 200 mg and linezolid 600 mg daily, or\n2. sorfequiline 100 mg daily for 17 weeks plus pretomanid 200 mg and linezolid 600 mg daily. Study treatment is administered orally once daily with food.\n\nThe primary objective is to assess safety through 17 weeks of treatment, including treatment-emergent adverse events, ECG findings, vital signs, laboratory assessments, visual acuity, and peripheral neuropathy. Secondary objectives include assessments of efficacy (time to stable sputum culture conversion; favorable outcome and treatment failure\u002Frelapse at 26 and 52 weeks after end of treatment) and pharmacokinetics of trial drugs, with exploratory analyses including predictors of culture conversion, exposure-response relationships, and quality of life.",[260],"Tuberculosis, Pulmonary",[262,23,263,264,265],"tuberculosis","drug sensitive tuberculosis","pretomanid","linezolid","NOT_YET_RECRUITING","2026-06-26",{"date":269,"type":270},"2026-06-30","ACTUAL",{"date":272,"type":254},"2026-07-01",{"date":274,"type":254},"2028-06-24",{"name":5,"class":6},11]