[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605486":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":38,"centralContacts":57,"locations":67,"responsibleParty":120,"collaborators":122,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":38,"enrollmentInfo":147,"targetDuration":38,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":167,"whyStopped":38,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"University College, London","OTHER",[8,17,22,26,30,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A. Immediate start of 24 weeks (approx. 6 months) TB treatment","ACTIVE_COMPARATOR","Immediate start of 24 weeks (approx. 6 months) TB treatment comprised of 8 weeks (approx. 2 months) isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE) followed by 16 weeks (approx. 4 months) of isoniazid and rifampicin (4HR) - 2HRZE\u002F4HR",[13,14,15,16],"Drug: Isoniazid (H)","Drug: Rifampicin (R)","Drug: Pyrazinamide (Z)","Drug: Ethambutol (E)",{"label":18,"type":19,"description":20,"interventionNames":21},"Arm B. Immediate start of 20 weeks (approx. 5 months) TB treatment","EXPERIMENTAL","Immediate start of 20 weeks (approx. 5 months) TB treatment comprised of 8 weeks (approx. 2 months) isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE) followed by 12 weeks (approx. 3 months) of isoniazid and rifampicin (3HR) - 2HRZE\u002F3HR",[13,14,15,16],{"label":23,"type":19,"description":24,"interventionNames":25},"Arm C. Immediate start of 16 weeks (approx. 4 months) TB treatment","Immediate start of 16 weeks (approx. 4 months) TB treatment comprised of 8 weeks (approx. 2 months) isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE) followed by 8 weeks (approx. 2 months) of isoniazid and rifampicin (2HR) - 2HRZE\u002F2HR",[13,14,15,16],{"label":27,"type":19,"description":28,"interventionNames":29},"Arm D. Immediate start of 12 weeks (approx. 3 months) TB treatment","Immediate start of 12 weeks (approx. 6 months) TB treatment comprised of 8 weeks (approx. 2 months) isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE) followed by 4 weeks (approx. 1 month) of isoniazid and rifampicin (1HR) - 2HRZE\u002F1HR",[13,14,15,16],{"label":31,"type":19,"description":32,"interventionNames":33},"Arm E. Immediate start of 8 weeks (approx. 2 months) TB treatment","Immediate start of 8 weeks (approx. 2 months) TB treatment comprised of isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE)",[13,14,15,16],{"label":35,"type":36,"description":37,"interventionNames":38},"Arm F. No initial treatment, deferred if progression.","NO_INTERVENTION","No initial treatment - if during close follow-up there is bacteriological confirmation and\u002For clinical\u002Fradiological progression, to start 24 weeks (approx. 6 months) TB treatment - 2HRZE\u002F4HR",null,[40,45,49,53],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":38},"DRUG","Isoniazid (H)","H, weight based, 150-375mg",[9,18,23,27,31],{"type":41,"name":46,"description":47,"armGroupLabels":48,"otherNames":38},"Rifampicin (R)","R, weight based, 300-750mg",[9,18,23,27,31],{"type":41,"name":50,"description":51,"armGroupLabels":52,"otherNames":38},"Pyrazinamide (Z)","Z, weight based, 800-2000mg",[9,18,23,27,31],{"type":41,"name":54,"description":55,"armGroupLabels":56,"otherNames":38},"Ethambutol (E)","E weight based, 550-1375mg",[9,18,23,27,31],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":38,"email":62},"Hanif Esmail, Prof","CONTACT","+44 20 7670 4700","h.esmail@ucl.ac.uk",{"name":64,"role":60,"phone":65,"phoneExt":38,"email":66},"Mags Thomason, Dr","+44 20 7670 4615","m.thomason@ucl.ac.uk",[68,83,97,106],{"facility":69,"status":38,"city":70,"state":38,"zip":38,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"National University of Medical Sciences","Islamabad","Pakistan","PK",{"type":74,"coordinates":75},"Point",[76,77],73.04329,33.72148,{"lat":77,"lon":76},[80],{"name":81,"role":60,"phone":38,"phoneExt":38,"email":82},"Asad Zaidi, Dr","syed.zaidi.22@ucl.ac.uk",{"facility":84,"status":38,"city":85,"state":38,"zip":38,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Clinical HIV Research Unit, Wits Health Consortium","Johannesburg","South Africa","ZA",{"type":74,"coordinates":89},[90,91],28.04363,-26.20227,{"lat":91,"lon":90},[94],{"name":95,"role":60,"phone":38,"phoneExt":38,"email":96},"Pauline Howell, Dr","phowell@witshealth.co.za",{"facility":98,"status":38,"city":85,"state":38,"zip":38,"country":86,"countryCode":87,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"The Aurum Institute",{"type":74,"coordinates":100},[90,91],{"lat":91,"lon":90},[103],{"name":104,"role":60,"phone":38,"phoneExt":38,"email":105},"Mmatsie Manentsa, Dr","mmanentsa@auruminstitute.org",{"facility":107,"status":38,"city":108,"state":38,"zip":38,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Bulawayo City Health","Bulawayo","Zimbabwe","ZW",{"type":74,"coordinates":112},[113,114],28.58333,-20.15,{"lat":114,"lon":113},[117],{"name":118,"role":60,"phone":38,"phoneExt":38,"email":119},"Mbusi Falayi, Dr","mfalayi@gmail.com",{"type":121,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[123,125,127,129,131,133,135],{"name":124,"class":6},"National University of Medical Sciences, Pakistan",{"name":126,"class":6},"Aurum Institute",{"name":128,"class":6},"Biomedical Research and Training Institute, Zimbabwe",{"name":130,"class":6},"Foundation for Innovative New Diagnostics, Switzerland",{"name":132,"class":6},"KTH Royal Institute of Technology",{"name":134,"class":6},"London School of Hygiene and Tropical Medicine",{"name":136,"class":6},"Wits Health Consortium (Pty) Ltd","100605486","phase-3-optimal-treatment-duration-for-radiographically-apparent-bacteriologically-unconfirmed-tb-identified-through-active-case-finding-radio-tb-trial-100605486",false,"NCT07163143","Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding (RADIO-TB Trial)","Optimal Treatment Duration for Radiographically Apparent, Bacteriologically Unconfirmed TB, Identified Through Active Case Finding","RADIO-TB","Inclusion Criteria:\n\n1. Aged ≥16 years old on day of randomisation\n2. ≥25kg in weight on day of randomisation\n3. Participation in community or facility-based active case finding for TB by CXR\n4. Digital CXR with Computer Aided Detection software score above threshold for sputum investigation for Mtb according to local guidance ≤21 days prior to randomisation\n5. Attempted sputum collection for testing by WHO approved rapid molecular test for Mtb at active case finding and at screening\n\nExclusion Criteria:\n\n1. Sputum sample from active case finding or screening confirmed as positive for Mtb by WHO approved rapid molecular test for Mtb\n2. Previous history of pulmonary TB\n3. TB preventive therapy taken within the last 6 months\n4. \\>1 dose of treatment with anti-tuberculous activity taken in the 21 days prior to randomisation\n5. HIV infected, unless CD4 ≥200 cells\u002Fmm3 and on anti-retroviral therapy for at least 8 weeks\n6. Pregnancy (confirmed by high sensitivity urine test)\n7. Contraindication to study drug\n8. Investigator concern for potential extra-pulmonary TB with the exceptions of (a) intrathoracic lymphadenopathy; and\u002For (b) small pleural effusion of limited extent, neither felt to require invasive diagnostic sampling\n9. CXR changes considered more likely to relate to a condition other than untreated TB by investigator\n10. Investigator assessment of an immediate requirement for full 24-weeks standard TB treatment\n11. Investigator assessment of unacceptable risks to potential participant from study entry\n12. No fixed home address\n13. Unable to participate in the full duration of study follow-up","ALL","16 Years",{"count":148,"type":149},784,"ESTIMATED","INTERVENTIONAL",[152],"PHASE3","People living in high TB burden communities who undergo active case finding for TB may have chest X-ray changes suggestive of TB but their sputum test can be negative for the TB bacteria or they are unable to provide a sputum sample. This means they have bacteriologically unconfirmed TB. These individuals often have minimal or no symptoms and face uncertainty in clinical management-either receiving full 24-weeks TB treatment or often being discharged without treatment, risking loss to follow-up.\n\nThe RADIO-TB trial aims to address the following main questions in relation to people with bacteriologically unconfirmed TB.\n\n1. What is the risk of progression if treatment is not immediately started but there is close and careful follow-up over 78 weeks?\n2. If treatment is started immediately what is the shortest duration of TB treatment that is as effective as the standard 24-week TB treatment?\n3. Are there better tests to confirm TB than the current routinely used, sputum-based tests?\n4. What is the cost effectiveness of different treatment strategies and what might the impact on transmission be within communities?\n\nParticipants in the trial will be randomized into six groups: five receiving immediate standard TB treatment of varying durations (8 to 24 weeks), and one receiving deferred treatment with close monitoring. Deferred treatment will be initiated only if clinical deterioration occurs or TB is later confirmed. Participants will be closely followed for 78 weeks with at least 11 clinic visits.",[155],"Tuberculosis (TB)",[157,158,159,160,161,162,163,164,165,166],"Treatment duration","Radiographically apparent TB","Bacteriologically unconfirmed TB","Response over continuous intervention (ROCI)","Active case finding","Asymptomatic","Subclinical","Chest X-ray","Screening","Computer Aided Detection (CAD)","NOT_YET_RECRUITING","2025-09-01",{"date":170,"type":171},"2025-09-09","ACTUAL",{"date":173,"type":149},"2025-11",{"date":175,"type":149},"2029-04",{"name":5,"class":6},4]