[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535583":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":59,"centralContacts":63,"locations":70,"responsibleParty":218,"collaborators":220,"id":224,"slug":225,"hasResults":226,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":226,"sex":231,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":68,"studyType":237,"phases":238,"briefSummary":240,"conditions":241,"keywords":246,"overallStatus":92,"whyStopped":68,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Regimen 1: Isoniazid (H), Rifampin (R), Pyrazinamide (Z), Ethambutol (E)","ACTIVE_COMPARATOR","8 weeks of daily HRZ(E) followed by either 16 or 24 weeks of daily HR, per local standard of care",[13,14,15,16],"Drug: Isoniazid","Drug: Rifampin","Drug: Pyrazinamide","Drug: Ethambutol",{"label":18,"type":19,"description":20,"interventionNames":21},"Regimen 2: Isoniazid (H), Rifapentine (P), Pyrazinamide (Z), Moxifloxacin (M)","EXPERIMENTAL","8 weeks of daily HPZM",[13,15,22,23],"Drug: Rifapentine","Drug: Moxifloxacin",[25,32,37,42,47,53],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Isoniazid","Once daily weight-based dose",[9,18],[31],"H",{"type":26,"name":33,"description":28,"armGroupLabels":34,"otherNames":35},"Rifampin",[9],[36],"R",{"type":26,"name":38,"description":28,"armGroupLabels":39,"otherNames":40},"Pyrazinamide",[9,18],[41],"Z",{"type":26,"name":43,"description":28,"armGroupLabels":44,"otherNames":45},"Ethambutol",[9],[46],"E",{"type":26,"name":48,"description":28,"armGroupLabels":49,"otherNames":50},"Rifapentine",[18],[51,52],"P","Priftin",{"type":26,"name":54,"description":28,"armGroupLabels":55,"otherNames":56},"Moxifloxacin",[18],[57,58],"M","Avelox",[60],{"name":61,"affiliation":5,"role":62},"Nicole Salazar-Austin, MD, ScM","PRINCIPAL_INVESTIGATOR",[64],{"name":65,"role":66,"phone":67,"phoneExt":68,"email":69},"Kisten Nolan, MPH, BSN","CONTACT","+14435403993",null,"knolan2@jh.edu",[71,90,105,121,138,155,172,188,201],{"facility":72,"status":73,"city":74,"state":68,"zip":68,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Indian Council of Medical Research - National Institute for Research in Tuberculosis","NOT_YET_RECRUITING","Chennai","India","IN",{"type":78,"coordinates":79},"Point",[80,81],80.27847,13.08784,{"lat":81,"lon":80},[84,89],{"name":85,"role":66,"phone":86,"phoneExt":87,"email":88},"Aishwarya Venkataraman, MBBS, DCH, PgDip PID, MRCPCH","+44 2836 9500","9533","venkataraman.a@icmr.gov.in",{"name":85,"role":62,"phone":68,"phoneExt":68,"email":68},{"facility":91,"status":92,"city":93,"state":68,"zip":68,"country":75,"countryCode":76,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Dr. D.Y. Patil Medical College, Hospital and Research Center","RECRUITING","Pune",{"type":78,"coordinates":95},[96,97],73.85535,18.51957,{"lat":97,"lon":96},[100,104],{"name":101,"role":66,"phone":102,"phoneExt":68,"email":103},"Shailaja Mane, MBBS, MD, PGDAP, FRIPH","+91 9822595553","shailaja.mane@dpu.edu.in",{"name":101,"role":62,"phone":68,"phoneExt":68,"email":68},{"facility":106,"status":92,"city":107,"state":68,"zip":68,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Faculty of Medicine, Universitas Padjadjaran","Bandung","Indonesia","ID",{"type":78,"coordinates":111},[112,113],107.60694,-6.92222,{"lat":113,"lon":112},[116,120],{"name":117,"role":66,"phone":118,"phoneExt":68,"email":119},"Rovina Ruslami, MD, PhD","+62895328254920","n.ruslami@gmail.com",{"name":117,"role":62,"phone":68,"phoneExt":68,"email":68},{"facility":122,"status":73,"city":123,"state":68,"zip":68,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Instituto Nacional de Saúde (INS)","Maputo","Mozambique","MZ",{"type":78,"coordinates":127},[128,129],32.58322,-25.96553,{"lat":129,"lon":128},[132,136],{"name":133,"role":66,"phone":134,"phoneExt":68,"email":135},"Celso Khosa, MD PhD","+25821311038","celso.khosa@ins.gov.mz",{"name":137,"role":62,"phone":68,"phoneExt":68,"email":68},"Celso Khosa, MD, PhD",{"facility":139,"status":92,"city":140,"state":68,"zip":68,"country":141,"countryCode":142,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Africa Health Research Institute (AHRI)","Durban","South Africa","ZA",{"type":78,"coordinates":144},[145,146],31.0292,-29.8579,{"lat":146,"lon":145},[149,153],{"name":150,"role":66,"phone":151,"phoneExt":68,"email":152},"Moherndran Archary, MBChB PhD","+270312604318","mo.archary@ahri.org",{"name":154,"role":62,"phone":68,"phoneExt":68,"email":68},"Moherndran Archary, MBChB, PhD",{"facility":156,"status":92,"city":157,"state":68,"zip":68,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"MU-JHU Care Ltd","Kampala","Uganda","UG",{"type":78,"coordinates":161},[162,163],32.58219,0.31628,{"lat":163,"lon":162},[166,170],{"name":167,"role":66,"phone":168,"phoneExt":68,"email":169},"Eric Wobudeya, MD","+256708162351","ewobudeya@mujhu.org",{"name":171,"role":62,"phone":68,"phoneExt":68,"email":68},"Eric Wobudeya, MBChB MMed MSc",{"facility":173,"status":92,"city":174,"state":68,"zip":68,"country":175,"countryCode":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"University of Zambia, School of Medicine","Lusaka","Zambia","ZM",{"type":78,"coordinates":178},[179,180],28.28713,-15.40669,{"lat":180,"lon":179},[183,187],{"name":184,"role":66,"phone":185,"phoneExt":68,"email":186},"Chishala Chabala, MBChB MMed MSc","+260977849537","cchabala@gmail.com",{"name":184,"role":62,"phone":68,"phoneExt":68,"email":68},{"facility":189,"status":92,"city":190,"state":68,"zip":68,"country":175,"countryCode":176,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Arthur Davison Children's Hospital","Ndola",{"type":78,"coordinates":192},[193,194],28.63659,-12.95867,{"lat":194,"lon":193},[197],{"name":198,"role":66,"phone":199,"phoneExt":68,"email":200},"Bwendo Nduna, MBChB, MMed (Paeds)","+260 96 6183841","bwendonduna@gmail.com",{"facility":202,"status":92,"city":203,"state":68,"zip":68,"country":204,"countryCode":205,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Harare Health and Research Consortium (HHRC)","Harare","Zimbabwe","ZW",{"type":78,"coordinates":207},[208,209],31.05337,-17.82772,{"lat":209,"lon":208},[212,216],{"name":213,"role":66,"phone":214,"phoneExt":68,"email":215},"Sukunena Maturure, RN","+263 772601735","smaturure@uz-ctrc.org",{"name":217,"role":62,"phone":68,"phoneExt":68,"email":68},"Mutsa Bwakura-Dangarembizi, MBChB, MMed (Paeds)",{"type":219,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR",[221],{"name":222,"class":223},"United States Agency for International Development (USAID)","FED","100535583","phase-3-shortened-regimen-for-drug-susceptible-tb-in-children-100535583",false,"NCT06253715","Shortened Regimen for Drug-susceptible TB in Children","SMILE-TB","Inclusion Criteria:\n\n* Parent or guardian is willing and able to provide written informed consent for potential participant's study participation; in addition, when applicable per Ethics Committee\u002FInstitutional Review Board (EC\u002FIRB) policies and procedures, potential participant is willing and able to provide assent for study participation.\n* At Entry, age of less than 10 years.\n* At Entry, weight 3 kilograms (kg) or greater.\n* At Entry, diagnosed with TB disease, defined as:\n\n  * Pulmonary (including pleural effusion) and\u002For lymph node (extra-thoracic and\u002For intra-thoracic) TB with or without bacteriologic confirmation;\n  * Clinician has decided to treat with standard first-line drug-susceptible TB regimen.\n* Known HIV status or HIV testing in progress based on meeting testing requirements.\n* Has normal, Grade 1 or 2 test results for all of the following done at or within 14 days of Entry (including the most recent):\n\n  * Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal;\n  * Total bilirubin less than or equal to 2.5 times the upper limit of normal;\n  * Potassium level of 3.0 milliequivalent\u002FL or greater;\n  * Hemoglobin level of 7.0 g\u002FdL or greater;\n  * Platelet count of 100,000\u002Fmm3 or greater;\n  * Estimated glomerular filtration rate (eGFR; bedside Schwartz formula) 60 mL\u002Fmin\u002F1.73m2 or higher.\n* For children living with HIV:\n\n  * On antiretroviral therapy (ART) at Entry: Must be on, or able to be switched to a dolutegravir-based regimen at or prior to Entry;\n  * Not on ART at Entry: Planned initiation of dolutegravir before or at study Week 4.\n* For participants who have reached menarche or who are engaging in sexual activity (self-reported): negative serum or urine pregnancy test within 7 days of Entry.\n* For participants who are engaging in sexual activity that could lead to pregnancy (self-reported): agrees to practice at least one non-hormonal method of contraception or abstain from heterosexual intercourse during study drug treatment and for 30 days after stopping study medications. Non-hormonal methods include:\n\n  * Male or female condoms\n  * Diaphragm or cervical cap (with spermicide, if available)\n  * Non-hormonal intrauterine device (IUD) or intrauterine system (IUS)\n* At Entry, intends to remain in the catchment area of the study site for the duration of study follow-up or willingness to be followed up beyond the catchment area if\u002Fwhen applicable, as determined by the site investigator based on participant\u002Fparent\u002Fguardian report.\n\nExclusion Criteria:\n\n* Presumed or documented extra-pulmonary TB involving the central nervous system and\u002For bones and\u002For joints, and\u002For miliary TB, and\u002For pericardial TB and\u002For TB of the gastrointestinal (GI) tract and\u002For renal TB.\n* Premature infant (born less than 37-weeks gestation) who is less than 3 months of age at Entry.\n* Any known contraindication to taking any study drug:\n\n  * Known allergy or intolerance to any of the study drugs or drugs in the same class as the study drugs;\n  * Any prohibited medications within three days prior to Entry or planned use within the following 6 months;\n  * Unable to take oral medications;\n  * Known history of prolonged QT syndrome not caused by electrolyte derangements.\n* Received more than 10 days of treatment directed against TB disease within 6 months preceding initiation of study drugs.\n* M. tuberculosis isolate known or suspected to be resistant to isoniazid, rifampin, pyrazinamide, ethambutol, and\u002For fluoroquinolones.\n* Known exposure to an infectious adult with drug-resistant TB, including resistance to isoniazid, rifampin, pyrazinamide, ethambutol, and\u002For fluoroquinolones.\n* Has any other documented or suspected clinically significant medical condition or any other condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* Previously enrolled in this study.\n\nLate Exclusions:\n\n* M. tuberculosis cultured or detected through World Health Organization (WHO) approved molecular assays (e.g., Cepheid Xpert MTB\u002FRIF, Xpert XDR, sequencing or Hain MTB-DR plus assays) from sputum, swallowed sputum, nasopharyngeal aspirates, stool, or lymph node aspirate obtained around the time of study entry is determined to be resistant to isoniazid and\u002For rifampin and\u002For pyrazinamide and\u002For ethambutol and\u002For fluoroquinolones.\n* Any child with a clinical TB diagnosis who is found to have a definitive alternative diagnosis for their presenting signs and symptoms whose TB treatment is discontinued prior to completion.","ALL","0 Days","9 Years",{"count":235,"type":236},860,"ESTIMATED","INTERVENTIONAL",[239],"PHASE3","While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.",[242,243,244,245],"Tuberculosis","Tuberculosis, Pulmonary","Tuberculosis, Lymph Node","Mycobacterium Tuberculosis",[247,248,249,250,251,252,253,254,255,256,257,258,259,260,261,262,263,264,265],"tuberculosis","pediatric","stratified medicine","shortened regimen","rifapentine","moxifloxacin","dolutegravir","drug-susceptible","lymph node","pulmonary","infections","TB","mycobacterium infections","respiratory tract infections","lung diseases","antitubercular agents","respiratory tract diseases","child","paediatric","2026-05-28",{"date":268,"type":269},"2026-06-01","ACTUAL",{"date":271,"type":269},"2025-01-15",{"date":273,"type":236},"2027-09-30",{"name":5,"class":6},9]