[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tuberculosis-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tuberculosis-infection":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,48,86,122,149,175,201,226,247,274,296],{"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":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100629259","isoniazid-related-hepatotoxicity-in-clinical-practice-incidence-and-predictors-100629259",false,"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.","ALL","18 Years",{"count":20,"type":21},220,"ESTIMATED","OBSERVATIONAL","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.",[25,26],"Tuberculosis Infection","Tuberculosis Infection, Latent",[28,29,30,31,32,33,34],"Isoniazid","INH-induced hepatotoxicity","Drug-induced liver injury","Tuberculosis","Corticosteroid therapy","Observational study","Adverse drug reactions","NOT_YET_RECRUITING","2026-03-10",{"date":38,"type":39},"2026-03-16","ACTUAL",{"date":41,"type":21},"2026-05-30",{"date":43,"type":21},"2026-09-01",{"name":45,"class":46},"ASST Fatebenefratelli Sacco","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":47},"100598291","phase-1-pharmacokinetics-of-antituberculosis-drugs-in-breastfeeding-women-100598291","NCT07069582","Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women","Plasma and Breastmilk Exposures to Antituberculosis Drugs in Breastfeeding Women: an Open-label, Randomized, Six-arm, Single-dose, Pharmacokinetic Study","PRiMe","Inclusion Criteria:\n\nParticipants may enter the study if all of the following apply:\n\n1. Healthy breastfeeding women aged 18 years or older, with a minimum of 3 months and a maximum of 24 months after delivery of a healthy baby, and are not currently diagnosed with either TB infection or TB disease.\n2. Have a body weight between 25 and 100 kg.\n3. Provide written informed consent.\n\nExclusion Criteria:\n\nParticipants may not enter the study if any of the following criteria apply:\n\n1. Grade 3-4 abnormalities on baseline blood chemistry tests, including serum alanine aminotransferase (ALT), creatinine, or blood glucose.\n2. Grade 3-4 abnormalities on baseline hematological tests, including white blood count, platelets, or hemoglobin.\n3. Contraindications or history of hypersensitivity\u002Fintolerance to rifampicin, isoniazid, levofloxacin, rifapentine, or bedaquiline.\n4. Taking concomitant medications for TB disease, TB infection, diabetes mellitus, hypertension, HIV, cardiac disease or any other chronic diseases.\n5. Having a breastfed infant who was diagnosed with TB infection or TB disease and is currently on treatment.\n6. Pregnancy\n7. Have an active, acute illness at the time of study enrolment.",true,"FEMALE",{"count":59,"type":21},60,"INTERVENTIONAL",[62],"PHASE1","This study is a sub-study of the SSTARLET trial (NCT06498414). The overall aim is to assess the pharmacokinetic profiles after taking a single dose of rifampicin, isoniazid, levofloxacin, rifapentine, and bedaquiline in breastfeeding women and the excretion of these drugs in breast milk, with the hope of including breastfeeding women in future clinical trials of TPT, including expanding the inclusion criteria of the SSTARLET trial. In this study, healthy breastfeeding women who fulfill the eligibility criteria will be enrolled from several primary health care centers in Bandung, which will be referred to the TB Research Clinic of the Universitas Padjadjaran, Bandung, Indonesia. Ten participants will be randomized to each of the following six study arms:\n\n* Arm A: Single-dose rifampicin at 10 mg\u002Fkg body weight (RIF10).\n* Arm B: Single-dose rifampicin at 20 mg\u002Fkg body weight (RIF20).\n* Arm C: Single-dose isoniazid at 5 mg\u002Fkg body weight (INH5).\n* Arm D: Single-dose levofloxacin at 10-15 mg\u002Fkg body weight (LFX10-15).\n* Arm E: Single-dose rifapentine at 10 mg\u002Fkg body weight (RPT10).\n* Arm F: Single-dose bedaquiline at 400 mg (BDQ400).",[25,65,66],"Healthy Volunteer","Breastfeeding",[68,69,70,71,72,73,74,75,28,76],"Tuberculosis infection","Latent tuberculosis infection","TBI","LTBI","Breastfeeding women","Rifampicin","Levofloxacin","Rifapentine","Bedaquiline","2026-02-06",{"date":79,"type":39},"2026-02-10",{"date":81,"type":21},"2026-04-01",{"date":83,"type":21},"2026-10-31",{"name":85,"class":46},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":60,"phases":98,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"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","5 Years","17 Years",{"count":97,"type":21},647,[99],"NA","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.",[25,102,103,104,26,31],"Household Contacts","Children","Adolescent",[106,107,68,108,103,104,109,31,110],"Household contacts","Prophylaxis","Mycobacterium tuberculosis","Randomized clinical trial","Cluster-randomized trial","RECRUITING","2025-12-20",{"date":114,"type":39},"2025-12-29",{"date":116,"type":39},"2025-10-27",{"date":118,"type":21},"2028-11",{"name":120,"class":46},"Pontificia Universidad Catolica de Chile",13,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":129,"maxAge":94,"enrollmentInfo":130,"targetDuration":4,"studyType":60,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":47},"100444611","phase-1-dolutegravir-pharmacokinetics-among-hivtb-coinfected-children-receiving-standard-and-high-dose-rifampicin-100444611","NCT05069688","Dolutegravir Pharmacokinetics Among HIV\u002FTB Coinfected Children Receiving Standard and High-dose Rifampicin","Mind the Gaps: Pharmacokinetic Research to Advance Pediatric HIV\u002FTB Cotreatment and TB Prevention","Inclusion Criteria:\n\n* ART-naïve or ART-experienced HIV-infected children between 4 weeks and \\\u003C6 years of age\n* Active TB diagnosis\n* Weight of at least 3 kilograms\n* Consent of the parent or legal guardian\n\nExclusion Criteria:\n\n* Baseline labs with evidence of ≥grade 3 abnormalities: ALT, total bilirubin, absolute neutrophil count (ANC), platelets, or creatinine\n* Suspected TB meningitis or presenting with acute respiratory distress or decompensation\n* Receipt of a medication that has drug-drug interactions with dolutegravir or rifampicin","4 Weeks",{"count":131,"type":21},20,[62],"Tuberculosis (TB) is the leading cause of death among children with HIV, yet insufficient data are available on the pharmacokinetics of newer HIV\u002FTB cotreatment strategies in children. Current WHO-recommended rifampicin dosages result in low concentrations in most children, and high-dose rifampicin may improve outcomes and shorten treatment duration. Yet the impact of high-dose rifampicin on dolutegravir exposures has not been examined in children. This study aims to evaluate the safety and pharmacokinetics of dolutegravir twice daily among HIV\u002FTB coinfected children receiving standard-dose and high-dose rifampicin.",[135,25],"Pediatric HIV Infection",[137,138,139],"pharmacokinetic","dolutegravir","rifampicin","2025-11-25",{"date":142,"type":39},"2025-12-02",{"date":144,"type":39},"2023-07-07",{"date":146,"type":21},"2026-12",{"name":148,"class":46},"Brigham and Women's Hospital",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":47},"100533105","testing-health-workers-at-risk-to-advance-our-understanding-of-tb-infection-100533105","NCT06221488","Testing Health Workers At Risk to Advance Our Understanding of TB Infection","THWART-TB: Testing Health Workers At Risk to Advance Our Understanding of TB Infection","THWART-TB","Inclusion Criteria:\n\n* ≥18 years old\n* Health worker\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Prior history of TB or known prior positive IGRA\n* Current or prior history of taking anti-TB treatment","100 Years",{"count":159,"type":21},300,"It has been estimated that 1.7 billion people have tuberculosis (TB) infection; yet current tests are unable to predict which people are at highest risk of developing TB disease, which can be life-threatening. THWART-TB is a prospective longitudinal cohort study of health workers (HWs) in Cape Town, South Africa, where our preliminary data reveals HWs have a high annual TB infection risk (34%). This cohort, who will undergo frequent serial evaluation (every 3 months) with a combination of novel assays never previously evaluated together, presents a unique opportunity to evaluate immune responses at the time of initial infection and to characterize the dynamic profile of these immune responses over time in a high-risk population. The knowledge generated will improve our understanding of TB infection and help to identify which people exposed to TB may remain at risk, enabling us to better target preventive strategies.",[31,25],[31,163,164,165],"TB","TB infection","Health worker","2025-05-20",{"date":168,"type":39},"2025-05-23",{"date":170,"type":39},"2024-01-15",{"date":172,"type":21},"2029-12-31",{"name":174,"class":46},"Beth Israel Deaconess Medical Center",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":60,"phases":184,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100530815","phase-3-1hp-versus-3hr-in-the-treatment-of-tuberculosis-infection-in-vietnam-100530815","NCT06191692","1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam","An Open-label, Randomized Controlled Trial of the New One-month Regimen Versus the Current Three-month Regimen for the Treatment of Tuberculosis Infection in Vietnam","Inclusion Criteria:\n\n* Household contacts of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiated treatment with residence in the intervention areas;\n* Positive QFT-Plus or TST results (TST induration of at least 5mm)\n* Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designed area for the duration of the study;\n* Age ≥ 18 years;\n* Capable of providing signed informed consent;\n* Willing to participate in the study visits and procedures\n\nExclusion Criteria:\n\n* Indeterminate results on QFT-Plus;\n* Clinical or radiographic suspicions or history of previous active TB;\n* Known hypersensitivity or contraindication to any components of the regimens;\n* Weight \\<30kg;\n* Acute or chronic liver failure with elevated liver enzymes or evidence of liver dysfunction such as jaundice or a history of liver failure caused by isoniazid or rifampicin; History of liver cirrhosis at any time before study entry;\n* Infection with suspected or confirmed tuberculosis strains resistant to isoniazid or rifampicin;\n* Porphyria- Porphyrin metabolism disorder;\n* Polyneuropathy (self-reported\u002F confirmed);\n* Pregnant or planning to become pregnant within 120 days of enrollment;\n* Any other severe underlying condition that would, in the opinion of the investigator, compromise the patient's safety or outcome in the trial;\n* Participation in other clinical intervention trials or research protocols (participation in other studies that do not involve an intervention may be allowed, but this must be discussed and approved by the Chief Investigator).",{"count":183,"type":21},350,[185],"PHASE3","Introduction: Tuberculosis (TB) infection is a key driver of the TB pandemic, with over 10.6 million people fell ill with TB disease in 2022. About one-quarter of the global population is estimated to be infected with TB bacteria. Around 5-10% of people with TB infection will develop active and contagious TB disease, which could be largely avoided if TB infection is identified and given effective preventative treatment, before progression to active disease. The long treatment of TB infection with regimens lasting from three to nine months is a significant barrier to treatment completion in individuals with a confirmed diagnosis of TB infection. Adapting a shorter regimen than the current regimens could lead to a higher treatment completion rate and increased uptake of preventative therapy for TB, as well as reduced side effects.\n\nMethods and analysis: An open-label, randomized clinical trial (1:1) will be performed in two study sites in Ha Noi, Vietnam (Vietnam National Lung Hospital and Ha Noi Lung Hospital). Adult household contacts (n=350) of people with new, bacteriologically-confirmed, pulmonary, drug-susceptible TB who initiate treatment will be invited to participate.\n\nAim: To compare the TB preventive therapy completion rates and adverse event incidence between a new one-month regimen (1HP) versus the current three-month regimen (3HR)\\*.\n\n\\*1HP= one month of daily isoniazid (H\u002FINH) and rifapentine (P\u002FRPT) 3HR= three months of daily isoniazid (H\u002FINH) and rifampicin (R\u002FRIF)",[25],[31,189,68,190,71,70],"TB preventive therapy","Latent TB infection","2025-03-17",{"date":193,"type":39},"2025-03-19",{"date":195,"type":21},"2025-08-01",{"date":197,"type":21},"2027-12-01",{"name":199,"class":46},"Freundeskreis Für Internationale Tuberkulosehilfe e.V",2,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":210,"conditions":211,"keywords":214,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":47},"100543215","effects-of-tuberculosis-infection-on-development-and-function-of-the-placenta-100543215","NCT06352970","Effects of Tuberculosis Infection on Development and Function of the Placenta","Effects of Tuberculosis Infection on Placental Development and Function","Inclusion Criteria:\n\n* Women admitted for delivery to study sites\n* Written informed consent\n* Age 18 years or greater\n\nExclusion Criteria:\n\n* Chronic comorbidities (other than TB, HIV or pregnancy-related disorder)\n* Twin pregnancy",{"count":209,"type":21},500,"The goal of this observational study is to understand how tuberculosis (TB) infection impacts the function and development of the placenta, and whether TB infection can contribute to pregnancy-related disorders through effects on the placenta.\n\nThe main questions it aims to answer are:\n\n* Does TB infection affect the structure of the placenta?\n* Does TB infection affect the function of the placenta?\n\nPregnant women attending delivery clinics in Addis Abeba, Ethiopia, will be enrolled and classified for TB infection using a blood-based test. We will compare the following outcomes between women with TB infection and women without TB infection:\n\n* Pathological lesions of the placenta\n* Gene and protein expression patterns linked to pregnancy-related disorders\n* Infant outcome at birth and at 6 weeks after birth",[212,25,213],"Pregnancy Related","Placenta Diseases",[215,216,217],"placenta","tuberculosis","pregnancy complication","2025-03-14",{"date":191,"type":39},{"date":221,"type":39},"2024-10-01",{"date":223,"type":21},"2027-12-31",{"name":225,"class":46},"Lund University",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":60,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":47},"100383341","immunological-biomarkers-in-tuberculosis-management-100383341","NCT04271397","Immunological Biomarkers in Tuberculosis Management","Optimization of Tuberculosis Diagnosis and Management Using Four Immunological Biomarkers","OPTI-4TB","Inclusion Criteria:\n\nAdult ≥ 18 year-old\n\n* Patients having given written consent\n* Patients accepting a follow up ≥ 6 months\n* Proven active tuberculosis (positive direct examination and\u002For PCR)\n* Latent tuberculosis infection assessed by positive IGRA\n\nExclusion Criteria:\n\n* Malignant solid tumor\n* Malignant hemopathy\n* Solid organ transplantation or hematopoietic stem cell transplantation\n* Immunosuppressive treatments (i.e. biologics, calcineurin inhibitors, corticosteroids)\n* Auto-inflammatory disease\n* Chronic liver diseases\n* Chronic infection with HIV, HCV (hepatitis C virus) or HBV (hepatitis B virus)\n* Antimycobacterial treatment initiated \\> 7 days\n* Pregnancy or breastfeeding\n* Refusal to participate to the study\n* Persons deprived of their liberty by judicial or administrative decision\n* Protected adults\n* Patients not affiliated to health-care social security\n* The homeless",{"count":59,"type":21},[99],"Tuberculosis (TB) is the leading cause of death by infectious disease in the world, responsible for 1.6 million deaths in 2017. The treatment of active TB requires at least a 6-month combined antibiotic regimen and can cause heavy side effects. As a consequence, treatment adherence is not optimal, particularly in primary care settings. Rapid and reliable monitoring of anti-TB treatment adherence and efficacy is critical to provide adequate patient care and curb relapse episodes and acquired drug resistance.\n\nInvestigators propose to evaluate the performance in terms of diagnosis accuracy and outcome prediction of four new biomarkers of active TB: 1) a double IGRA (Interferon Gamma Release Assay) including QuantiFERON-Gold Plus® and HBHA; 2) a whole blood transcriptomic analysis of mRNA (messenger Ribonucleic acid) expression of a panel of 150 genes; 3) a whole blood proteomic analysis; 4) an ex vivo immunophenotyping using flow and mass cytometry to characterize the lymphocyte populations.",[31,25],"2024-08-09",{"date":240,"type":39},"2024-08-12",{"date":242,"type":39},"2019-09-30",{"date":244,"type":21},"2026-10-10",{"name":246,"class":46},"Hospices Civils de Lyon",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":254,"enrollmentInfo":255,"targetDuration":4,"studyType":60,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":47},"100473306","phase-1-safety-and-tolerability-of-chlorquine-in-addition-to-anti-tuberculosis-therapy-100473306","NCT05443178","Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy","Open Label, Single Center, Phase 1 Dose Escalation and Extension Trial to Evaluate Safety and Tolerability of Chlorquine as Adjuvant Drug to Standard 4-drug Anti-tuberculosis Therapy in Healthy Volunteers","Inclusion criteria:\n\n1. Informed study-specific consent (including possible pharmacogenetic analysis) as documented by signature\n2. Healthy volunteers aged between 18 and 50 years of age (significantly increased risk of side effects from 50 years of age with Rimstar®)\n\nExclusion criteria:\n\n1. Lack of highly effective contraception during the study treatment and for 8 months after the last dose of study treatment (until Day 254, visit 7) according to 11.4 with the following consideration for participating women:\n\n   * From Day 1 (visit 2) up to Day 30 (visit 6) hormonal contraception is insufficient due to lower concentrations of estrogen and\u002For gestagen during and up to 14 days after Rimstar® intake. The hormonal contraception must be supplemented with a barrier method (preferably male condom).\n   * From Day 30 (visit 6) up to Day 254 (visit 7) hormonal contraceptive methods can be used and are considered highly effective.\n2. Pregnant or lactating females\n3. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, glucose-6-phosphate dehydrogenase insufficiency (favism)\n4. Regular treatment with drugs in the last 14 days prior to first intake of study drug (except for Paracetamol and Vitamin B6 (pyridoxine), see 8.7).\n5. History of or concurrent, clinically significant cardiac, immunological, pulmonary, neurological, renal, gastrointestinal, dermatological, endocrinological or other major disease as determined by the Investigator and\u002For his representative\n6. History of or presence of any clinically significant abnormality in vital signs, ECG, or laboratory test results or has any medical or psychiatric condition that, in the opinion of the Investigator, may interfere with the study procedures or compromise subject safety\n7. History of or currently present retinopathy or other disturbances of the field of vision or the retina according to the Investigator\n8. History of alcohol or substance abuse for the last 3 months prior to Screening, as determined by the Investigator\n9. Weight less than 55kg\n10. Intake of grapefruit juice or grapefruits within 2 weeks before the first study drug administration and during treatment phase\n11. Donation of blood or blood products within a 30-day period prior to Screening\n12. Current enrolment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 3 months of participation to the Clear trial.\n13. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant\n14. The investigator, his\u002Fher family members, employees and other dependent persons","50 Years",{"count":256,"type":21},16,[62],"In vitro and in vivo data show promising results of adjunctive use of Chloroquine to standard tuberculosis therapy as Chloroquine enhances animicrobial effectiveness against intracellular MTB. To date, no safety data of the concurrent use of both treatments is availble. In a phase I trial, the investigators aim to evaluate safety and tolerability of the concurrent use of Chloroquine and standard anti-TB drug in healthy volunteers.",[25],[261,262,263,264],"Safety and tolerability","Chloroquin as adjuvant to standard 4-drug anti-TB therapy","Healthy volunteers","Phase I trial","2024-06-28",{"date":267,"type":39},"2024-07-01",{"date":269,"type":39},"2022-01-04",{"date":271,"type":21},"2025-06-01",{"name":273,"class":46},"University of Zurich",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":281,"maxAge":18,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100538348","multicenter-italian-cohort-study-on-tuberculosis-in-pediatric-age-100538348","NCT06289660","Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age","Multicenter Italian Observational Cohort Study on Tuberculosis in Pediatric Age","Inclusion Criteria:\n\n* Pediatric patients (0-18 years old) at the time of the initial observation\n* Patients affected by active and latent TB, as defined by the criteria of the World Health Organization\n* Patients exposed to TB who are found to be non-infected at the end of the window period\n* Informed consent signed by parents\u002Flegal guardian or by the patient who has reached the legal age of consent, assent of the minor\n\nExclusion Criteria:\n\n* None","1 Week",{"count":283,"type":21},1000,"According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide.",[25],"2024-02-29",{"date":288,"type":39},"2024-03-04",{"date":290,"type":39},"2022-12-22",{"date":292,"type":21},"2033-03-01",{"name":294,"class":46},"Meyer Children's Hospital IRCCS",17,{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":307,"conditions":308,"keywords":312,"overallStatus":111,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":47},"100497387","prevalence-of-latent-tuberculosis-infection-in-health-care-workers-and-students-100497387","NCT05756582","Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students","Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.","CROSSWORD","Inclusion Criteria:\n\n* all health-care workers of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome,\n* all students of all three-year and single-cycle degree courses, master's degree courses, graduate schools of the faculty of Medicine and Surgery of the Catholic University of Sacred Heart in Rome, trained at the Fondazione Policlinico Universitario A. Gemelli IRCCS,\n* written informed consent.\n\nExclusion Criteria:\n\n* denied informed consent.","72 Years",{"count":306,"type":21},2040,"This study is a cross-sectional study that examines the prevalence of Latent Tuberculosis Infection \\[LTBI\\], defined as individuals infected with Mycobacterium tuberculosis with no clinical evidence of disease, and the possible risk factors of LTBI in a large cohort of health care workers (HCWs) and students.",[31,309,25,310,311],"Tuberculosis, Pulmonary","Latent Tuberculosis","Health Care Associated Infection",[313,314,315,316],"latent tuberculosis infection","health-care workers","students","survey","2024-02-12",{"date":319,"type":39},"2024-02-13",{"date":321,"type":39},"2021-11-17",{"date":323,"type":21},"2026-12-15",{"name":325,"class":46},"Eleonora Nucera"]