[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tuberculosis-infection-latent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tuberculosis-infection-latent":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,82,112,142],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100644037","rifapentine-based-shorter-regimens-for-tuberculosis-and-tb-infection-in-kazakhstan-100644037",false,"NCT07668479","Rifapentine-Based Shorter Regimens for Tuberculosis and TB Infection in Kazakhstan","Research on Evaluating Rifapentine-Based Shorter Regimens for Tuberculosis and Tuberculosis Infection Among People Living With and Without HIV in Programmatic Settings in Kazakhstan (RIFA-REAL)","RIFA-REAL","Inclusion Criteria:\n\nFOR DS-TB COHORTS (2HPMZ\u002F2HPM and 2HRZE\u002F4HR):\n\n* Age 18 years or older\n* Bacteriologically confirmed drug-susceptible pulmonary tuberculosis\n* Newly diagnosed, not previously treated (or treated less than 1 month)\n* Willing and able to provide written informed consent\n* Residing in one of the four pilot regions of Kazakhstan\n\nFOR TBI COHORT (1HP):\n\n* Age 18 years or older\n* Diagnosed with tuberculosis infection\n* No evidence of active tuberculosis disease\n* Willing and able to provide written informed consent\n* Residing in one of the four pilot regions of Kazakhstan\n\nExclusion Criteria:\n\nFOR DS-TB COHORTS:\n\n* Confirmed or suspected drug-resistant tuberculosis (rifampicin-resistant tuberculosis (RR-TB) or multidrug-resistant tuberculosis (MDR-TB))\n* Extrapulmonary tuberculosis as the sole manifestation\n* Pregnancy or breastfeeding at time of enrollment\n* Severe hepatic impairment (alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3x upper limit of normal)\n* Known hypersensitivity to rifapentine, isoniazid, moxifloxacin, or pyrazinamide\n* corrected QT interval (QTc) interval \\>500 ms on baseline electrocardiogram (ECG)\n* Currently receiving medications with significant interactions contraindicated with study regimens\n\nFOR TBI COHORT:\n\n* Active tuberculosis disease\n* Previous treatment for TB or TBI within the past 2 years\n* Pregnancy at time of enrollment\n* Severe hepatic impairment\n* Known hypersensitivity to rifapentine or isoniazid","ALL","18 Years",{"count":20,"type":21},350,"ESTIMATED","OBSERVATIONAL","RIFA-REAL is a prospective observational longitudinal study evaluating the safety, feasibility, and effectiveness of rifapentine-based shorter treatment regimens for drug-susceptible tuberculosis (DS-TB) and tuberculosis infection (TBI) under routine programmatic conditions in Kazakhstan.\n\nThe study enrolls three cohorts: patients with DS-TB receiving the 4-month isoniazid-rifapentine-moxifloxacin-pyrazinamide regimen (2HPMZ\u002F2HPM), patients with DS-TB receiving the standard 6-month isoniazid-rifampicin-pyrazinamide-ethambutol regimen (2HRZE\u002F4HR), and individuals with TBI receiving the 1-month rifapentine-isoniazid regimen (1HP). Participants include people living with and without HIV.\n\nThe study is conducted across four regions of Kazakhstan and is funded through the Western-Eastern European Partnership Initiative on HIV, Viral Hepatitis and TB (WEEPI) grant. Findings will inform national TB policy and contribute to global evidence on programmatic implementation of rifapentine-based regimens.",[25,26,27],"Tuberculosis","Tuberculosis Infection, Latent","Tuberculosis, Pulmonary, Drug Sensitive",[29,30,31,32,33,34,35,36],"rifapentine","4HPMZ","1HP","drug-susceptible tuberculosis","TB infection","shorter treatment regimen","operational research","HIV","NOT_YET_RECRUITING","2026-06-21",{"date":40,"type":41},"2026-06-25","ACTUAL",{"date":43,"type":21},"2026-07-01",{"date":45,"type":21},"2027-08",{"name":47,"class":48},"Public Union \"Kazakhstan Association of Phthisiopulmonologists\"","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100554386","phase-2-shorter-and-safer-treatment-regimens-for-latent-tb-100554386","NCT06498414","Shorter and Safer Treatment Regimens for Latent TB","SSTARLET: Shorter and Safer Treatment Regimens for Latent TB","SSTARLET","Inclusion Criteria:\n\n* Adults, and children aged ≥5 years with weight of \\> 15Kg.\n* Positive test for TB infection: either Tuberculin test (\\>5mm, or \\>10mm, based on epidemiologic and clinical factors and interpreted following local guidelines) or interferon gamma release assay based on Manufacturer's criteria; and,\n* Recommended for Tuberculosis Preventive Treatment (TPT), following Canadian guidelines (for Canadian sites), and World Health Organization (WHO) guidelines (for international sites).\n\nExclusion Criteria:\n\n* Current tuberculosis (TB) disease - detected pre-enrolment with symptom screen, chest x-ray, and confirmatory microbiological (culture or genotypic) testing as needed; Prior to referral to research staff (research clinic) for consideration as potential participants, all persons must undergo symptoms screen and a chest Xray. If chest Xray is not available, then a negative results from a GeneXpert MTb RIF Ultra of spontaneous (expectorated) sputum will be considered sufficient to exclude TB disease pre-referral. If Chest Xray is abnormal or symptoms consistent with TB disease are present then at least two AFB smears and mycobacterial cultures must be done, and must be negative, or one GeneXpert MTb Rif Ultra must be negative before enrolment\n* Children aged 0-4 years;\n* Persons weighing \\\u003C15 kg.\n* Women who are pregnant or breast-feeding;\n* Women of child-bearing potential and not willing to take an effective form of contraception (non-hormonal) during the treatment phase;\n* Documented prior treatment for tuberculosis (TB) infection or disease;\n* Pre-enrolment - alanine transaminase (ALT), White Blood Cells, platelets or hemoglobin that correspond to a Grade 3 adverse event (AE);\n* Rifampin or rifapentine contra-indicated - due to allergy\u002Fhypersensitivity to any rifamycin (rifampin, rifabutin or rifapentine), or, drug interactions too difficult to manage;\n* Have a prolonged QT interval on routine ECG pre-enrolment or take any medications that may prolong the QT interval and that are not recommended to take with a fluroquinolone. (See APPENDIX 5 in supplement for list of medications contra-indicated to take with Levofloxacin);\n* Household contacts (HHC) of index TB patients with phenotypic or genotypic resistance to Rifampin or Levofloxacin. HHC may be enrolled, then excluded post-randomization, if resistance is identified later. Note that all sites routinely test Rifampin resistance in all people newly diagnosed to have TB disease, but do not test routinely for susceptibility to Levofloxacin unless Rifampin resistance is detected. Hence HHCs may be enrolled if their Index TB patient is Rifampin susceptible, even if Drug Susceptibility Testing to Levofloxacin is not done and\u002For not available.","5 Years",{"count":59,"type":21},1800,"INTERVENTIONAL",[62,63],"PHASE2","PHASE3","Our study rationale is based on:\n\n1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe;\n2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are superior with respect to acceptance, completion, and costs;\n3. 4 months of Rifampin 10mg\u002Fkg (4R10) is the safest regimen, but is completed by \\\u003C80% of patients;\n4. The safety of 2 months of Rifampin 20mg\u002Fkg (2R20) is similar to that of 4 months of Rifampin 10mg\u002Fkg (4R10), but completion is a concern;\n5. 1-month regimens have promising efficacy;\n6. Safety and tolerability must be carefully assessed with comparisons to 4 months of Rifampin 10mg\u002Fkg (4R10), and head-to-head with each other.\n\nOBJECTIVES: The investigator will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one regimen of ≤2 months duration that has non-inferior safety, completion, and tolerability in adults and children relative to the reference Tuberculosis Preventive Treatment (TPT) regimen. The shortest, safest, and best tolerated regimen identified in this Phase 2 trial will be tested for effectiveness and efficacy in a Phase 3 trial.\n\nSpecific Tuberculosis Preventive Treatment (TPT) regimens (All are daily and self-administered) Reference: Rifampin at a dose of 10 mg\u002Fkg\u002Fday for 4 months (4R10); Experimental: 1) Rifampin at 20 mg\u002Fkg\u002Fday for 2 months (2R20); (2) one month Levofloxacin and Rifapentine (1LP). At a later stage a 3rd experimental regimen will be selected and added: one another novel 1-2-month regimen identified from pre-clinical and clinical studies. When selected, this will be explained fully including preliminary data on safety and efficacy in an amended protocol and consent - which will be submitted for ethics and regulatory approval at that time).",[26],[67,68,69,70],"Tuberculosis infection","Rifampin","Short treatment for latent tuberculosis","High dose rifampin","RECRUITING","2026-05-06",{"date":74,"type":41},"2026-05-11",{"date":76,"type":41},"2025-06-10",{"date":78,"type":21},"2029-06-01",{"name":80,"class":48},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",14,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":111},"100629259","isoniazid-related-hepatotoxicity-in-clinical-practice-incidence-and-predictors-100629259","NCT07472348","Isoniazid-Related Hepatotoxicity in Clinical Practice: Incidence and Predictors","Observational Study on Isoniazid-Induced Hepatotoxicity: Incidence, Risk Factors and Therapeutic Strategies","INH-DILI","Inclusion Criteria:\n\n* Adults aged ≥18 years.\n* Patients diagnosed with TB or LTBI who received INH as part of their treatment regimen (either first-line or second-line therapy), regardless of combination with other anti-TB drugs.\n* Normal baseline liver function tests (ALT, AST and bilirubin within reference range) and absence of clinical symptoms of liver dysfunction prior to initiation of anti-TB therapy.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients who did not receive isoniazid during their treatment course.\n* Pre-existing liver dysfunction, including biliary origin, before anti-TB therapy.\n* Pregnancy or lactation.\n* Concomitant use of non-TB hepatotoxic drugs.\n* Abnormal hepatic function on baseline laboratory testing.\n* Known INH resistance at treatment initiation.\n* Refusal to provide informed consent.",{"count":91,"type":21},220,"The objective of this observational study is to determine how frequently isoniazid (INH) causes liver injury (hepatotoxicity) in adults treated for tuberculosis (TB) or latent tuberculosis infection (LTBI) and to understand which factors increase this risk. The study also aims to describe how hepatotoxicity is managed in real-world clinical practice and whether treatments such as corticosteroids can improve liver function tests.\n\nThe main questions this study aims to answer are:\n\n* How frequently does INH-induced hepatotoxicity occur in adults treated for TB or LTBI?\n* What demographic, clinical, microbiological, or lifestyle factors increase the risk of developing hepatotoxicity?\n* How do different management strategies, including treatment modification or the use of corticosteroids, affect liver recovery and completion of TB\u002FLTBI therapy? This study does not involve experimental treatments. Researchers will analyze information already collected during routine clinical care, both retrospectively (from 2020 to 2025) and prospectively (2026-2028). There is no comparison group, but participants may have different clinical profiles or treatments, which will be compared to understand risk factors and outcomes.\n\nParticipants will:\n\n* Receive standard treatment for tuberculosis or LTBI, including isoniazid, as prescribed by their treating physicians.\n* Undergo routine assessments, such as blood tests, microbiology, imaging, and clinic visits, as part of their regular care.\n* Their clinical data will be recorded in the study database to analyze liver function trends, treatment changes, and outcomes.\n\nThe study will contribute to improving understanding of INH-induced hepatotoxicity and supporting safer and more effective treatment strategies for tuberculosis and LTBI.",[94,26],"Tuberculosis Infection",[96,97,98,25,99,100,101],"Isoniazid","INH-induced hepatotoxicity","Drug-induced liver injury","Corticosteroid therapy","Observational study","Adverse drug reactions","2026-03-10",{"date":104,"type":41},"2026-03-16",{"date":106,"type":21},"2026-05-30",{"date":108,"type":21},"2026-09-01",{"name":110,"class":48},"ASST Fatebenefratelli Sacco",1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":120,"sex":121,"minAge":122,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":60,"phases":125,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":111},"100625202","burden-of-tuberculosis-among-pregnant-and-postpartum-women-in-guinea-bissau-100625202","NCT07419568","Burden of Tuberculosis Among Pregnant and Postpartum Women in Guinea-Bissau","Assessing the Burden of Tuberculosis Among Pregnant and Postpartum Women: Implications for Integrating Tuberculosis Screening Into Routine Antenatal Care in Guinea-Bissau","TIPP","Inclusion Criteria:\n\n* Pregnant women ≥ 15 years of age\n* Residing in the study\n* Attending ANC consultations at health centre in Bandim, Belem or Cuntum\n* Must provide informed consent\n\nExclusion Criteria:\n\n* Pregnant women ≤ 15 years of age\n* Inability to provide informed consent\n* Residing outside of the study area\n* Receives TB treatment at the time of, or a year prior to, enrolment",true,"FEMALE","15 Years",{"count":124,"type":21},720,[126],"NA","This study aims to address critical diagnostic and data gaps in tuberculosis (TB) care among pregnant and postpartum women in Guinea-Bissau, a high-burden, resource-limited setting. Recognising that current TB screening during antenatal care (ANC) relies largely on unstructured symptom questions, the study will integrate more systematic and innovative approaches into routine maternal health services.\n\nThe project will implement the Bandim TBscore II as a structured triage tool to classify symptom severity and guide referrals. To strengthen diagnostic capacity, two novel tools will be evaluated: stool-based GeneXpert testing (a method recommended in children and explored here as a feasible alternative for pregnant women) and artificial intelligence-powered chest X-ray interpretation software designed to enhance TB detection where radiological expertise is lacking.\n\nThe study will also generate comprehensive, population-based data on TB and TB infection (TBI) among pregnant, postpartum women and women of reproductive age in Guinea-Bissau. The results are intended to inform health policy, both locally and in high-income countries, by providing evidence to improve TB screening protocols and care for this vulnerable group. Ultimately, the study seeks to develop scalable strategies that can be replicated across low- and middle-income countries to advance maternal and child health and support global TB eradication efforts.",[129,26,130,131,132],"Tuberculosis (TB)","Pregnancy","Tuberculosis Diagnosis","Maternal Health","2026-02-14",{"date":135,"type":41},"2026-02-19",{"date":137,"type":21},"2026-02",{"date":139,"type":21},"2027-11",{"name":141,"class":48},"Aarhus University Hospital",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":60,"phases":153,"briefSummary":154,"conditions":155,"keywords":159,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100599617","window-prophylaxis-for-pediatric-tuberculosis-prevention-trial-100599617","NCT07086820","Window Prophylaxis for Pediatric Tuberculosis Prevention Trial","Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled Trial","TB-WIN","Inclusion Criteria:\n\n* Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis\n* Age ≥5 to \\\u003C18 years old\n\nExclusion Criteria:\n\n* Suspected active tuberculosis in initial assessment (clinical or radiological)\n* Current pregnancy or breastfeeding\n* Immunocompromised\n* Allergy or contraindication to isoniazid or rifapentine\n* Chronic liver disease or alcohol use disorder\n* History of previous treatment for active or latent tuberculosis infection\n* Previous tuberculin skin test\n* Household contacts of a tuberculosis index patient with a known or suspected drug-resistant M. tuberculosis strain\n* Household contacts or a tuberculosis index patient currently living away from home for more than four weeks\n* Household contacts of a tuberculosis index patient who have already received more than 15 daily doses of antituberculous treatment","17 Years",{"count":152,"type":21},647,[126],"The goal of this cluster-randomized controlled trial is to evaluate the effectiveness of tuberculosis preventive treatment (TPT) administered during the \"window period\" to prevent new Mycobacterium tuberculosis infections in children and adolescents.\n\nThe main question it aims to answer is:\n\nCan immediate TPT reduce the incidence of IGRA conversions in children and adolescents who are household contacts of a newly diagnosed pulmonary tuberculosis patient?\n\nResearchers will compare the incidence of new tuberculosis infections-measured by IGRA conversion at 12 weeks-between participants who receive immediate TPT while still uninfected (baseline IGRA-negative) and those who receive standard care, in which TPT is not offered to IGRA-negative contacts.\n\nParticipants will be:\n\n1. Tested for M. tuberculosis infection using the Interferon-Gamma Release Assay (IGRA), specifically the QuantiFERON-TB Gold Plus, at enrollment and after 12 weeks of follow-up.\n2. Take weekly isoniazid and rifapentine for 12 weeks if:\n\n   1. They are assigned to the intervention arm (regardless of baseline IGRA result), or\n   2. They are in the control arm and test IGRA-positive at baseline.\n\nAdditionally, participants from the control arm who experience an IGRA conversion at 12 weeks (following the primary outcome assessment) will also receive TPT, as per standard of care.",[94,156,157,158,26,25],"Household Contacts","Children","Adolescent",[160,161,67,162,157,158,163,25,164],"Household contacts","Prophylaxis","Mycobacterium tuberculosis","Randomized clinical trial","Cluster-randomized trial","2025-12-20",{"date":167,"type":41},"2025-12-29",{"date":169,"type":41},"2025-10-27",{"date":171,"type":21},"2028-11",{"name":173,"class":48},"Pontificia Universidad Catolica de Chile",13]