[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tuberculosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tuberculosis":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,84,0,25,[9,43,74,113,143,170,200,221,258,283,308,329,354,395,421,448,472,496,518,540,562,585,610,631,657],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100645123","tuberculosis-clinical-registry-in-europe-100645123",false,"NCT07677904","Tuberculosis Clinical Registry in Europe","Tuberculosis Clinical Registry in Europe - the TBnet Registry","Inclusion Criteria:\n\n* Diagnosis of Tuberculosis\n* Age ≥ 18 years\n* Capacity to provide informed consent\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Lack of capacity to provide informed consent\n* Age \\\u003C 18 years","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","The TBnet registry is a multinational, prospective tuberculosis registry established by the Tuberculosis Network European Trialsgroup (TBnet e.V.) to collect and analyze long-term data from TB patients across Europe. Its purpose is to centralize data on TB epidemiology, prevention, diagnosis, and treatment to improve care, support research, and ultimately help eliminate TB. The registry captures risk factors, diagnostic details (e.g., microbiology, imaging, drug resistance), treatment data, side effects, outcomes, and late complications.",[25],"Tuberculosis",[27,28,29],"registry","extrapulmonary tuberculosis","PTLD","NOT_YET_RECRUITING","2026-06-24",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":21},"2026-07",{"date":38,"type":21},"2040-12",{"name":40,"class":41},"Research Center Borstel","OTHER",2,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100644037","rifapentine-based-shorter-regimens-for-tuberculosis-and-tb-infection-in-kazakhstan-100644037","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",{"count":52,"type":21},350,"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.",[25,55,56],"Tuberculosis Infection, Latent","Tuberculosis, Pulmonary, Drug Sensitive",[58,59,60,61,62,63,64,65],"rifapentine","4HPMZ","1HP","drug-susceptible tuberculosis","TB infection","shorter treatment regimen","operational research","HIV","2026-06-21",{"date":68,"type":34},"2026-06-25",{"date":33,"type":21},{"date":71,"type":21},"2027-08",{"name":73,"class":41},"Public Union \"Kazakhstan Association of Phthisiopulmonologists\"",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":89,"conditions":90,"keywords":97,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100298003","phase-1-antigen-specific-cytotoxic-t-cells-in-the-treatment-of-opportunistic-infections-100298003","NCT03159364","Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections","Phase I\u002FII Multicenter Trial of Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections","Inclusion Criteria:\n\nSubjects with or without hematopoietic stem cell transplantation \u002F organ transplant recipients need to meet the following conditions:\n\n* Evidence of CMV, EBV, ADV, BKV or known pathogen infection (viral DNA, immunohistochemical cytology positive); contraindications or invalid to anti-microbial drugs.\n* Subjects with virus DNA increased in the 2 consecutive peripheral blood samples (≥ 1000 genomic copies\u002Fml blood) at least 24 hours apart.\n* Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 0.5x109 \u002F L, platelet (PLT) ≥ 20x109 \u002F L.\n* Patients with pahogen disease (organ\u002F tissue infiltration) symptoms, fever, diarrhea, or lymphadenopathy, regardless of the level of peripheral blood virus DNA, and confirmed by the presence of viral DNA or microbial antigens within body fluid or biopsy.\n* The subject \u002F guardian has signed a written consent form before any trial begins.\n\nProper renal and hepatic functions (ULN denotes \"upper limit of normal range\"):\n\n* Creatinine ≤ 2\\*ULN.\n* Bilirubin ≤ 2\\*ULN.\n* SGOT ≤ 3\\*ULN.\n* SGPT≤ 3\\*ULN.\n\nIf CTL is not from the patient's own, then the provider of CTLs needs to meet the following criteria:\n\n* Did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.\n* White blood cells ≥ 3,500 \u002F μl, lymphocytes ≥ 750 \u002F μl.\n* Obtain a signed informed consent from the patient and \u002F or the guardian or the donor of the BMT recipient.\n* Human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or tuberculosis (TB) test is negative.\n* Physical examination in line with the standard of healthy blood donors.\n\nExclusion Criteria:\n\n* Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), or HTLV (HTLV antibody positive).\n* GVHD (graft-versus-host disease) performance score at II-IV.\n* Subject is albumin-intolerant.\n* Subject with life expectancy less than 4 weeks.\n* Subject participated in other investigational somatic cell therapies within past 30 days.\n* Subject with positive pregnancy test result.","6 Months","80 Years",{"count":84,"type":21},100,"INTERVENTIONAL",[87,88],"PHASE1","PHASE2","Epstein Barr Virus (EBV) or Cytomegalovirus (CMV) infection results in significant morbidity and mortality in hematopoietic stem cell transplantation (HSCT) patients. HSCT patients often face opportunistic infections due to the immunosuppressive state during transplantation. Antimicrobial drugs are usually used for prophylactic purposes and for treatment after early detectable infections. Unfortunately, some patients develop resistance to such drug treatment. In addition to HSCT patient, immune compromised patient may also be victim to opportunistic infections. Many infections can be effectively managed by functional immune recovery. In this study, the safety and efficacy of microbial-specific cytotoxic T lymphocytes (CTLs) will be investigated.",[91,92,93,94,95,96,25],"Pathogen Infection","EBV Infection","CMV Infection","Adenovirus Infection","BKV Infection","Fungus Infection",[98,99,100,101],"CTL","Virus CTL","Fungus CTL","TB CTL","RECRUITING","2026-06-18",{"date":105,"type":34},"2026-06-22",{"date":107,"type":34},"2026-06-01",{"date":109,"type":21},"2030-12-31",{"name":111,"class":41},"Shenzhen Geno-Immune Medical Institute",1,{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":4,"leadSponsor":140,"locationsCount":112},"100149071","training-protocol-on-the-natural-history-of-tuberculosis-100149071","NCT01212003","Training Protocol on the Natural History of Tuberculosis","Natural History of Tuberculosis","* INCLUSION CRITERIA:\n\nFOR ALL PATIENTS\n\nPatients may be included in this study who:\n\n* Have or are suspected to have TB infection.\n* Are aged 2 years or older.\n* Have a primary care physician, infectious diseases physician, pulmonologist, or TB specialist outside of the NIH who can provide care of his or her TB infection outside the NIH, provide directly observed therapy (DOT) if necessary, and monitor for side effects and toxicity of TB medications.\n* Are willing to consent to storage of specimens for future research.\n* Able to provide informed consent for themselves or, if they lack the capacity to provide informed consent, have an appropriate Legally Authorized Representative (LAR; the study team will comply with NIH Human Research Protection Program \\[HRPP\\] Policy 403).\n\nFOR PATIENTS WITH LATENT TB\n\nIn addition to the above-described inclusion criteria for all patients, patients may be included in the Latent TB part of this protocol who:\n\n-Have documented evidence of a positive purified protein derivative (PPD) skin test or Interferon-gamma Release Assays (IGRA) test meeting American Thoracic Society (ATS)\u002FCDC guidelines for latent TB; conversion can have occurred at any time.\n\nFOR PATIENTS WITH ACTIVE TB\n\nIn addition to the above-described inclusion criteria for all patients, patients may be included in the Active TB part of this protocol who:\n\n* Have active TB of any drug susceptibility pattern and any site of infection as determined by smear, culture, or biopsy.\n* Have appropriately documented clinically suspicious active TB without definitive microbiology confirmation.\n\nEXCLUSION CRITERIA:\n\nPatients will be excluded from this study who:\n\n* Are incarcerated.\n* Have been ordered by a court to take TB medications.\n* Are unwilling or unable to comply with prescribed therapy.\n* Are pregnant.\n\nEXCLUSION OF SPECIFIC POPULATIONS\n\nChildren: Children under the age of 2 are not eligible to enroll. The addition of the very young will not provide enough additional insights to justify the risk to this specific population.\n\nPregnant women: Pregnant women are not eligible for participation in this protocol because the study objectives can be achieved without the enrollment of this population. Enrolled participants who become pregnant during the study will be withdrawn.","2 Years","100 Years",{"count":123,"type":21},150,"Background:\n\n\\- Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.\n\nObjectives:\n\n\\- To collect blood and other samples to study the natural history of tuberculosis.\n\nEligibility:\n\n\\- Individuals 2 years of age and older who have either active or latent tuberculosis.\n\nDesign:\n\n* Latent TB patients: Participants will have a single study visit with a physical examination and medical history, and will provide blood samples for testing.\n* Active TB patients: Participants will have an initial visit with a physical examination and medical history, and will provide blood samples for testing. Participants will also provide sputum samples if required, and may have an optional skin punch biopsy to collect a sample of skin tissue for study.\n* Treatment for active TB will be provided as part of this protocol.\n* Active TB participants may be asked to return for study visits every 1-2 months while receiving treatment....",[126,127,128,25,129],"Mycobacterium Infections","Tuberculosis, Multidrug-Resistant","Latent Tuberculosis","Extensively Drug-Resistant Tuberculosis",[131,132,133,128,134,135,25],"TB","Mycobacterium Tuberculosis","Active Tuberculosis","MDR TB","Natural History","2026-06-17",{"date":103,"type":34},{"date":139,"type":34},"2011-06-30",{"name":141,"class":142},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":17,"minAge":151,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":85,"phases":155,"briefSummary":156,"conditions":157,"keywords":158,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":112},"100641169","phase-2-re-evaluating-the-duration-in-children-of-tb-treatment-100641169","NCT07656012","Re-evaluating the Duration in Children of TB Treatment","Multi-arm, Open-label, Duration-randomized, Phase IIc Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of Optimized Rifampicin in Combination With Isoniazid, Pyrazinamide, and Ethambutol for the Treatment of Children With Drug-susceptible Tuberculosis","REDUCE TB","Inclusion Criteria:\n\n* 3 months to less than 10 years of age\n* Body weight greater than or equal to 3 kilograms (kg) and less than 45 kg at study entry\n* Confirmed or clinically diagnosed intrathoracic (pulmonary) and\u002For some forms of extrathoracic (extrapulmonary) drug-susceptible TB:\n\n  * Confirmed intrathoracic (pulmonary) TB, based on chest radiograph and\u002For symptoms consistent with TB, and\u002For some forms of extrathoracic TB, with all of the following as determined by the site investigator:\n\n    * Microbiological confirmation of M. tuberculosis from any clinical specimen by either culture or molecular methods\n    * At least rifampicin-susceptibility demonstrated by genotypic (molecular) or phenotypic methods\n    * Documented clinical decision to treat for drug-susceptible TB\n  * Clinically diagnosed intrathoracic (pulmonary) TB, based on chest radiograph and\u002For symptoms consistent with TB, and\u002For some forms of extrathoracic TB, with all of the following as determined by the site investigator:\n\n    * Documented clinical decision to treat for drug-susceptible TB\n* HIV positive or negative\n* For participants living with HIV, they must be on a dolutegravir-based antiretroviral therapy regimen at the time of study entry\n\nExclusion Criteria:\n\n* Received routine treatment for TB disease for greater than 5 days at the time of enrollment\n* Exposure to a case of intrathoracic TB in the 12 months prior to enrollment with known or suspected resistance to any of the drugs in the treatment regimens OR confirmed resistance on molecular or phenotypic drug-susceptibility testing to any drugs in the treatment regimens\n* Has greater than or equal to grade 3 results of any of the following during screening: creatinine, serum ALT, AST, total bilirubin\n* Has hemoglobin less than 7.5 g\u002FdL during screening\n* Has TB meningitis, osteoarticular TB, or miliary TB as determined by the site investigator\n* Severe renal, pulmonary, cardiac, gastrointestinal, neurologic or any other condition that in the judgement of the investigator would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives\n* Use of any prohibited drug within 3 days of enrollment\n* Severe acute malnutrition defined as weight-for-height\u002Flength z-score or BMI-for-age z-score less than -3\n* Hypersensitivity to any of the study drugs (rifampicin, isoniazid, pyrazinamide or ethambutol)\n* For Main Trial (Step 2) participants, previously enrolled in the Lead-in PK Study (Step 1)","3 Months","9 Years",{"count":154,"type":21},230,[88],"Current tuberculosis (TB) treatment is effective (works well), but it takes a long time to cure TB. This study will evaluate if TB treatment with a higher dose of rifampicin, one of the TB medicines, and shorter TB treatment duration is as effective and safe as the standard, TB treatment (with the usual rifampicin dose and usual duration). This study hopes to find a better shorter treatment that works as well as the current treatment (standard of care). This could benefit children worldwide who are getting TB treatment.\n\nChildren 3 months to less than 10 years of age who have drug-susceptible TB (can be successfully treated with standard TB medicines) are eligible for this study.",[25],[159,160,161],"children","rifampicin","duration randomization","2026-06-15",{"date":103,"type":34},{"date":165,"type":21},"2026-09",{"date":167,"type":21},"2030-09",{"name":169,"class":41},"University of Wisconsin, Madison",{"id":171,"slug":172,"hasResults":12,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":17,"minAge":177,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":85,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100641915","phase-2-a-trial-of-stratified-patient-centered-treatment-regimens-for-active-tb-spectra-tb-100641915","NCT07595042","A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)","A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB","Inclusion Criteria:\n\n* Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.\n* Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.\n* Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.\n* Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.\n* If living with HIV, has a CD4+ cell count of at least 50 cells\u002Fmm3 within 60 days before study entry.\n* If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.\n* Has laboratory test results within 7 days before study entry that meet all of the following:\n\n  * alanine aminotransferase (ALT) no more than 3 times the upper limit of normal\n  * total bilirubin no more than 2.5 times the upper limit of normal\n  * creatinine no more than 2 times the upper limit of normal\n  * potassium between 3.5 and 5.5 mEq\u002FL\n  * absolute neutrophil count at least 1000\u002Fmm3\n  * hemoglobin at least 7.0 g\u002FdL\n  * platelet count at least 100,000\u002Fmm3\n* If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.\n* If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:\n\n  * condoms\n  * intrauterine device (IUD) or intrauterine system (IUS)\n  * cervical cap with spermicide\n  * diaphragm with spermicide\n* If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.\n* Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.\n* Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.\n\nExclusion Criteria:\n\n* TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.\n* Received more than 5 days of treatment for active TB within the 24 weeks before study entry.\n* Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.\n* Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.\n* Has a past history of suspected or confirmed drug-resistant TB of any type.\n* Is currently pregnant or breastfeeding.\n* Cannot take medicines by mouth.\n* Has an HIV\u002FAIDS-related opportunistic infection at study entry.\n* Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.\n* Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.\n* Has alcohol-related liver disease.\n* Has liver cirrhosis.\n* Has a history of aortic aneurysm or aortic dissection.\n* Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.\n* Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.\n* Has a known history of acute intermittent porphyria.\n* Weighs less than 30 kg.\n* Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.\n* Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.\n* Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.\n* Is currently taking part in another interventional clinical trial.","13 Years",{"count":179,"type":21},900,[88],"The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.",[25],[25,184,185,186,187,188,189,190,191],"Pulmonary tuberculosis","Drug-susceptible tuberculosis","Rifampin-susceptible tuberculosis","Rifapentine","Moxifloxacin","HIV coinfection","Treatment shortening","Risk-stratified treatment","2026-06-11",{"date":162,"type":34},{"date":195,"type":21},"2026-07-31",{"date":197,"type":21},"2029-10-22",{"name":141,"class":142},29,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":177,"enrollmentInfo":207,"targetDuration":4,"studyType":85,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100602518","phase-1-a-study-of-daily-rifapentine-combined-with-isoniazid-1hp-for-tuberculosis-prevention-in-children-less-than-13-years-of-age-with-and-without-hiv-100602518","NCT07124559","A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Phase I\u002FII Dose Finding, Safety and Tolerability Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV","Inclusion Criteria:\n\n1. A parent or legal guardian must be willing and able to give written permission for the child to participate in the study. If required by local policies, the child must also be willing and able to give written assent to participate. All sites must follow local policies and procedures.\n2. Age requirements at entry:\n\n   * Cohort 1: Children under 13 years old.\n   * Cohort 2: Children aged 12 weeks to under 13 years old.\n3. For Cohort 1 participants under 28 days old: The child must have been born at or after 37 weeks of pregnancy, as determined by the site investigator using parent\u002Fguardian report or medical records.\n4. Weight requirements at entry:\n\n   * Cohort 1: 3 kg to under 45 kg.\n   * Cohort 2: 6 kg to under 45 kg.\n5. HIV status:\n\n   * Cohort 1: Must be living without HIV.\n   * Cohort 2: Must be living with HIV.\n6. At risk of TB disease, defined as meeting at least one of the following:\n\n   * Having close contact with someone with infectious pulmonary TB within the past six months.\n   * A positive tuberculin skin test (TST) or, for those over two years old, a positive interferon gamma release assay (IGRA) if TST is not available.\n   * For Cohort 2 only: Living in a high TB burden area (≥ 60 TB cases per 100,000 people per year).\n7. Normal or mild (grade 1 or 2) test results for the following at screening (within 21 days before entry):\n\n   * ALT (liver enzyme)\n   * Estimated glomerular filtration rate (kidney function)\n   * Absolute neutrophil count (white blood cells)\n   * Hemoglobin (red blood cells)\n8. For Cohort 2 participants:\n\n   * Must have been on antiretroviral therapy (ART) for at least 12 weeks before entry.\n   * Must have been on a specific ART regimen (once-daily DTG and two NRTIs) for at least 14 days before entry.\n   * Must have used the same formulation of DTG (tablet or dispersible tablet) for at least three days before entry.\n   * Must agree to continue the same formulation of DTG for the study duration.\n   * Must have an HIV-1 RNA level below 200 copies\u002FmL at screening.\n9. Must intend to stay in the same area for the study duration.\n10. Must have access to at least one meal per day during the 28-day treatment period.\n\nExclusion Criteria:\n\n1. The child has active TB, confirmed by medical records, parent\u002Fguardian report, or tests during screening, indicated by:\n\n   * Currently being treated for active TB.\n   * Symptoms like poor growth, poor weight gain, weight loss, cough for at least 11 days, or fever for at least eight days.\n   * X-ray or CT scan showing TB.\n   * Positive TB test results (e.g., culture, Xpert MTB\u002FRIF Ultra, Truenat M.tb, other nucleic acid tests, urine tests).\n2. The child has been exposed to an adult with drug-resistant TB (resistant to Rifampicin or Isoniazid) within the past six months.\n3. The child has taken the following medications:\n\n   * Daily Isoniazid in the 28 days before entry.\n   * Any prohibited medications listed in the study within three days before entry.\n4. The child has any of the following conditions:\n\n   * Acute or chronic hepatitis.\n   * Allergy to Isoniazid or rifamycins.\n   * Porphyria.\n   * Severe peripheral neuropathy.\n5. The child has severe acute malnutrition (weight-for-height\u002Flength less than -3 z-scores of WHO standards). Note: Children who are stunted (height-for-age more than two standard deviations below WHO standards) are eligible.\n6. For Cohort 2: The child has an active AIDS-defining opportunistic infection.\n7. The child has started menstruation.\n8. The child has taken NVP, EFV, lopinavir\u002Fritonavir, and\u002For raltegravir within 14 days before entry.\n9. The child has received long-term immunosuppressive therapy (more than eight days) within 30 days before entry. Note: Short courses of steroids (seven days or less) may be allowed with approval.\n10. The child is a result of a multiple birth (e.g., twins, triplets).\n11. The child has any other significant medical condition that would make participation unsafe, complicate data interpretation, or interfere with study objectives, as determined by the site investigator.",{"count":208,"type":21},144,[87,88],"This study aims to find the proposed dose of Rifapentine (RPT) taken once daily with Isoniazid (INH) for 28 days to prevent tuberculosis (TB). The study will take place at multiple locations and children under 13 years old will be divided into two groups: one group will include children without HIV, and the other group will include children with HIV who are on antiretroviral treatment. Up to 144 children will participate, and participants in each group will be followed for 24 weeks.",[25],[65,25,128],{"date":214,"type":34},"2026-06-12",{"date":216,"type":21},"2026-07-15",{"date":218,"type":21},"2028-05-31",{"name":141,"class":142},11,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":231,"studyType":22,"phases":4,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":42},"100584776","prospective-cohort-of-people-starting-treatment-for-tuberculosis-disease-in-france-frenchtb-100584776","NCT06893757","Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)","Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France - ANRS 464s FrenchTB","FrenchTB","Inclusion Criteria:\n\n* Aged ≥18 years.\n* Diagnosis of tuberculosis by microbiological or clinical means, including on the basis of a pathological examination for extrapulmonary tuberculosis leading to a Compulsory Declaration (CD) and treated for less than 8 days.\n* Have signed a voluntary, informed and written consent (at the latest on the day of inclusion and before any examination carried out as part of the research), or alternatively, consent from relatives in cases of tuberculous meningitis or other serious forms of tuberculosis with impaired consciousness or confusion, until the person is able to give their consent.\n\nExclusion Criteria:\n\n* Presence of significant cognitive impairment that, in the opinion of the site investigator or designated person, may affect the ability to give reliable informed consent (except in the specific case of meningeal tuberculosis).",{"count":230,"type":21},2000,"5 Years","The French Tuberculosis Cohort is a prospective, national, multicenter, low-intervention study including subjects aged 18 years and older with tuberculosis disease for which inpatient treatment is initiated. The goal of this observational study is to follow-up and anti-tuberculosis treatment will be provided according to current French recommendations. Participants will provide sociodemographic, clinical, biological, radiological and bacteriological data at various protocol visits at 2 days, 1 and 2 weeks, 2 months, at the end of treatment, 12 and 24 months. Consenting participants will have samples collected at scheduled visits for the establishment of a biobank. This will include blood, urine, breath and hair samples. The positive mycobacterial strains will constitute a specimen bank.",[25],[235,236,237,238,239,240,241,242,243,244,245,246,247,248],"infectious diseases","tuberculosis","clinical","social sciences","public health","Comorbidities","epidemiology","Treatment and care","Transmission","France","biobank","mycobacterial collection","cohort","prospective","2026-06-10",{"date":214,"type":34},{"date":252,"type":34},"2026-05-06",{"date":254,"type":21},"2031-06",{"name":256,"class":257},"ANRS, Emerging Infectious Diseases","OTHER_GOV",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":265,"sex":17,"minAge":18,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":85,"phases":269,"briefSummary":263,"conditions":270,"keywords":272,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":280,"locationsCount":112},"100642208","phase-1-a-phase-i-study-of-lipovaxin-tuberculosis-vaccine-in-adult-healthy-populations-100642208","NCT07647107","A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations","A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia","Inclusion Criteria\n\n1. Clinically Healthy participants aged 18-40 years;\n2. Participants have been informed properly regarding the study and signed the informed consent form.\n3. Participants will commit to comply with the instructions of the investigator and the schedule of the trial;\n4. Participants must have a negative IGRA and sputum.\n5. Clinically normal laboratory values for ureum, creatinine, SGOT, SGPT, complete blood count (CBC), urinalysis, coagulation test (PT, aPTT), total cholesterol, Globulin\u002FAlbumin ratio and CRP\n\nExclusion Criteria:\n\n1. Those who are currently diagnosed with tuberculosis or have a history of tuberculosis (positive IGRA or GenXpert sputum test or chest Xray suggestive of TB) and\u002For history of tuberculosis treatment; including TB Preventive Treatment (TPT);\n2. There are serious chronic diseases, or the disease is in the advanced stage that cannot be controlled smoothly, such as diabetes and thyroid disease;\n3. Currently suffering from or within 2 years of any of the following serious diseases, such as: advanced tumor, autoimmune disease, progressive atherosclerosis, acute exacerbation of the chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure, etc.; based on interview with participants\n4. Those with known or suspected (or high-risk) immune function impairments or abnormalities, such as those receiving more than 20mg\u002Fday of systemic glucocorticoids for 14 consecutive days within the last 4 weeks, immunosuppressants within 3 months, and Those who received protein preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months;\n5. People with allergic constitution, such as those with a history of allergy to two or more drugs or foods; a history of severe allergy to any component of the test vaccine, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia Purpura, dyspnea, angioedema, etc.; or a history of the above-mentioned serious side effects after using any vaccine or drug in the past; history of bronchial asthma;\n6. Current patients with HIV antibody positive for human immunodeficiency virus;\n7. Women who are pregnant, breastfeeding, or have a positive urine pregnancy test during the screening period, or before vaccination, or who have childbearing plans during the study period;\n8. Subjects receive any vaccination within 1 month before and after dosing;\n9. Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research;\n10. Any other situation that the researcher believes may affect the evaluation of the research.",true,"40 Years",{"count":268,"type":21},60,[87],[25,271],"TB Infection",[273,25,274],"TB vaccine","Lipovaksin TB","2026-06-09",{"date":162,"type":34},{"date":278,"type":21},"2026-08",{"date":71,"type":21},{"name":281,"class":282},"PT Bio Farma","INDUSTRY",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":291,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":85,"phases":293,"briefSummary":295,"conditions":296,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100475637","phase-3-doxycycline-host-directed-therapy-to-improve-lung-function-and-decrease-tissue-destruction-in-pulmonary-tuberculosis-100475637","NCT05473520","Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis","Doxycycline Host-directed Therapy to Improve Lung Function and Decrease Tissue Destruction in Pulmonary Tuberculosis: A Phase III Randomized Control Trial (Doxy-TB)","Doxy-TB","The recruitment target would be 150 patients, with 75 in each arm\n\nInclusion criteria: Patients should meet all criteria:\n\n1. Aged 21 years and above\n2. Patients receiving ≤ 14 days of TB treatment or about to start standard combination TB treatment\n3. Confirmed pulmonary TB with positive acid-fast bacilli smear and\u002For positive nucleic acid amplification test (NAAT) and\u002For TB culture results\n4. CXR demonstrating pulmonary involvement with cavity or cavities\n5. Able to provide informed consent\n\nExclusion criteria:\n\n1. HIV co-infection\n2. Previous pulmonary TB\n3. Severe, pre-existing lung disease such as pulmonary fibrosis, bronchiectasis, COPD and lung cancer\n4. Pregnant or breast feeding\n5. Allergies to tetracyclines\n6. Patients on retinoic acid, neuromuscular blocking agents and pimozide which may increase risk of drug toxicity\n7. Autoimmune disease and\u002For on systemic immunosuppressants\n8. Use of any investigational or non-registered drug, vaccine or medical device other than the study drug within 182 days preceding dosing of study drug, or planned use during the study period\n9. Enrolment in any other clinical trial involving a systemic drug or intervention involving the lung\n10. Evidence of severe depression, schizophrenia or mania\n11. ALT \\> 3 times upper limit of normal\n12. Creatinine \\> 2 times upper limit of normal\n13. Principal investigator assessment of lack of willingness to participate and comply with all requirements including follow-up of the protocol, or identification of any factor felt to significantly increase the participant's risk of suffering an adverse outcome","21 Years",{"count":123,"type":21},[294],"PHASE3","Tuberculosis (TB) is a global pandemic that despite successful treatment and bacterial eradication can cause chronic ill health, such as pulmonary impairment after tuberculosis (PIAT) and cardiovascular disease (CVD). A recent Phase 2b double-blind randomised-controlled clinical trial shows that adjunctive doxycycline therapy is safe, accelerates resolution of inflammation, suppresses tissue damaging enzyme activity and decreases pulmonary cavity volume (1). We aim to determine if adjunctive doxycycline can reduce PIAT and improve cardiovascular outcomes in a fully powered Phase III trial of 8 weeks of adjunctive doxycycline alongside standard pulmonary TB (PTB) treatment.\n\nThe investigators hypothesize that doxycycline inhibits tissue destruction in patients with PTB and thereby leads to improved lung function after treatment.\n\nSpecific aims\n\n1. To assess improvement in lung function as measured by forced expiratory volume (FEV1) predicted in PTB patients given doxycycline versus placebo.\n2. To investigate whether doxycycline will hasten the resolution of pulmonary cavities measured by CT thorax\n3. To investigate whether doxycycline can suppress inflammatory markers including matrix metalloproteinases\n4. To investigate whether doxycycline can accelerate time to sputum conversion\n5. To evaluate the effect of doxycycline on cardiovascular outcomes such as the incidence of acute coronary syndrome (ACS) and pulmonary hypertension\n6. To investigate whether doxycycline improves TB drug concentrations in sputum and plasma.\n7. To assess the safety profile of doxycycline with concurrent standard anti-tuberculous treatment.",[25,297,298],"Acute Coronary Syndrome","Pulmonary Hypertension (Diagnosis)","2026-06-08",{"date":275,"type":34},{"date":302,"type":34},"2023-05-24",{"date":304,"type":21},"2030-01-31",{"name":306,"class":41},"National University Hospital, Singapore",6,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":315,"targetDuration":317,"studyType":22,"phases":4,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":112},"100643198","effect-of-mycobacterial-infection-on-immune-status-100643198","NCT07638670","Effect of Mycobacterial Infection on Immune Status","EMIIS","Inclusion Criteria and Exclusion Criteria:\n\nInclusion Criteria：\n\n1. Age ≥ 18 years, all genders and races accepted.\n2. Patients with active pulmonary tuberculosis diagnosed clinically or by bronchoscopy within less than 1 week.\n3. Patients with latent tuberculosis infection (positive T-SPOT test but no evidence of active tuberculosis infection).\n4. Patients with tuberculous pleurisy with onset within less than 1 week.\n5. Voluntarily join this study and sign the informed consent form.\n6. Patients whose drug susceptibility test or NGS results indicate resistance to at least isoniazid and rifampicin (MDR-TB).\n7. Patients whose drug susceptibility test or NGS results indicate sensitivity to first-line anti-tuberculosis drugs.\n8. Patients whose drug susceptibility test or NGS results indicate resistance to only one anti-tuberculosis drug.\n9. Patients with newly identified nontuberculous mycobacterial infection (within less than 1 week) by sputum culture or NGS.\n\nExclusion Criteria：\n\n1. Immunosuppressive conditions including HIV infection, long-term use (\\>1 month) of immunosuppressive agents or corticosteroids, severe malnutrition, etc.\n2. Concurrent other lung diseases, severe liver or kidney dysfunction, severe endocrine diseases, hematological diseases, or malignant tumors that may affect the study outcomes.\n3. Patients with diabetes mellitus.\n4. Pregnant or lactating women.\n5. Patients unable or unwilling to provide informed consent, or with poor compliance.",{"count":316,"type":21},120,"60 Days","This study, titled \"Effect of Mycobacterial Infection on Immune Status\" (EMIIS), investigates the immune-driven mechanisms of mycobacterial infections, focusing on the dynamic immune characteristics of multidrug-resistant tuberculosis (MDR-TB), nontuberculous mycobacterial (NTM) infections, and tuberculous pleurisy. Mycobacterial infections (including the Mycobacterium tuberculosis complex and nontuberculous mycobacteria) remain a major global public health threat. EMIIS is a single-center, randomized, single-blind,prospective study. The study recruited 120 participants, divided into groups of healthy individuals\u002Fcommunity-acquired pneumonia patients, active pulmonary tuberculosis patients, latent tuberculosis infection patients, tuberculous pleurisy patients, and nontuberculous mycobacteria patients. Blood samples were collected from all groups within 3 days before treatment and 2-3 months after treatment. Pleural effusion samples were additionally collected from the tuberculous pleurisy group within 3 days before treatment and 2 months after treatment. Exhaled breath condensate (EBC) was collected from the nontuberculous mycobacteria group. Utilizing mass cytometry (CyTOF) and multi-dimensional indicators, the study aims to elucidate the immune-driven mechanisms of mycobacterial infections and provide new strategies for individualized treatment.",[25],"2026-06-04",{"date":249,"type":34},{"date":323,"type":34},"2025-07-09",{"date":325,"type":21},"2026-07-20",{"name":327,"class":328},"First Affiliated Hospital of Ningbo University","NETWORK",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":85,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":353},"100618492","phase-3-steroids-and-enhanced-spectrum-antibiotics-for-the-treatment-of-patients-in-africa-with-refractory-sepsis-100618492","NCT07332325","STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis","STeroids and Enhanced Spectrum Antibiotics for the Treatment of Patients in Africa With Refractory Sepsis (STARS Trial)","STARS","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female aged ≥18 years living with HIV\n4. Admitted to hospital with 1) clinical concern for infection; 2) ≥2 qSOFA score criteria (Glasgow Coma Scale score \\\u003C15, a respiratory rate ≥22, or a systolic blood pressure ≤90 mmHg or a mean arterial pressure of ≤65 mmHg)\n5. Resident within a pre-defined geographic area to ensure TB clinic follow-up\n6. For females of reproductive potential: use of highly effective contraception through 28 days\n\nExclusion Criteria:\n\n1. Known active TB or receiving anti-TB therapy\n2. Pregnancy or lactation. Women will undergo urine pregnancy screening. Pregnant people will be excluded due to lack of pharmacokinetic data for the expanded antibiotic regimen in pregnancy.\n3. Known allergic reactions to the components of the interventional therapy\n4. Treatment with another investigational drug or other intervention within one month\n5. Known liver disease\n6. Alcohol use \\> 14 standardized drinks per week and\u002For \\> 4 drinks per day for men and \\>7 standardized drinks per week and\u002For \\>3 drinks per day for women, defined as 14 grams of ethanol, as found in example 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of 80 proof spirits\n7. Positive serum cryptococcal antigen test\n8. Current treatment with a drug known to have significant, non-correctable interaction with anti-TB therapy\n9. Already receiving corticosteroids at the time of presentation to the hospital",{"count":338,"type":21},344,[294],"Sepsis, a life-threatening condition due to a dysregulated response to infection, is the leading cause of global mortality and is frequently driven by tuberculosis (TB) and drug-resistant bacteria in sub-Saharan Africa, particularly among people living with HIV. The prevailing standard of care in the region, ceftriaxone alone, is insufficient as it does not address TB, drug-resistant bacteria, or adrenal insufficiency, which is common in HIV-related sepsis. Therefore, the investigators propose a randomized 2x2 factorial clinical trial to compare 28-day survival from sepsis between study participants who along with a standard of care that includes immediate conventional anti-TB treatment receive 1) hydrocortisone to treat septic shock and 2) rifampin, isoniazid, levofloxacin and linezolid to treat TB and other drug-resistant bacteria in order to deliver important and scalable knowledge that may alter the standard of care for sepsis in HIV endemic settings of sub-Saharan Africa. Improving understanding of the physiology and treatment alternatives for HIV related critical illness globally will have reciprocal benefit for health in the U.S.",[342,25],"Sepsis",[342,65,236,344],"Africa","2026-05-29",{"date":107,"type":34},{"date":348,"type":21},"2026-10",{"date":350,"type":21},"2029-09",{"name":352,"class":41},"University of Virginia",4,{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":17,"minAge":361,"maxAge":152,"enrollmentInfo":362,"targetDuration":4,"studyType":85,"phases":364,"briefSummary":365,"conditions":366,"keywords":369,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":394},"100535583","phase-3-shortened-regimen-for-drug-susceptible-tb-in-children-100535583","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.","0 Days",{"count":363,"type":21},860,[294],"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.",[25,367,368,132],"Tuberculosis, Pulmonary","Tuberculosis, Lymph Node",[236,370,371,372,58,373,374,375,376,377,378,131,379,380,381,382,383,384,385],"pediatric","stratified medicine","shortened regimen","moxifloxacin","dolutegravir","drug-susceptible","lymph node","pulmonary","infections","mycobacterium infections","respiratory tract infections","lung diseases","antitubercular agents","respiratory tract diseases","child","paediatric","2026-05-28",{"date":107,"type":34},{"date":389,"type":34},"2025-01-15",{"date":391,"type":21},"2027-09-30",{"name":393,"class":41},"Johns Hopkins University",9,{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":405,"conditions":406,"keywords":410,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":112},"100639596","tb-stigma-in-the-uk-patients-experiences-and-everyday-responses-100639596","NCT07609264","TB Stigma in the UK: Patients Experiences and Everyday Responses","Making Sense of Tuberculosis (TB) Related Stigma in a Low-incidence Area of the UK: Patients Experiences and Everyday Responses","TB stigma","This study seeks participants who have been diagnosed with pulmonary TB, extrapulmonary TB, latent TB infection (LTBI), and drug sensitive or drug resistant TB within the last 10 years. Participants may have different cultural and socioeconomic backgrounds and will be resident within a pre-defined TB low-incidence coastal\u002Frural area of the UK.\n\nInclusion criteria\n\n* Aged 18 or over at start of study\n* Resident in rural or coastal areas within South or Southwest England\n* Diagnosed with either active or latent TB within the last 10 years\n\nExclusion criteria\n\n* Lacks mental capacity or is unwilling to consent to participate in the study\n* Under 18 years of age\n* Lives in an area of TB high-incidence (above 10 cases\u002F100,000 population) or outside of rural and coastal areas of South\u002FSouthwest England",{"count":404,"type":21},20,"Public understanding of tuberculosis (TB) is shaped by sociocultural norms, educational background, and personal experiences. Misconceptions about TB transmission, disease severity, and treatment side effects are widespread, contributing to stigma and fear of social rejection. Such stigma can lead individuals to conceal their diagnosis, limiting access to support, engagement with healthcare, and overall health literacy.\n\nTB-related stigma is recognised as a significant barrier to ending the global TB epidemic, affecting quality of life and access to care. Yet in high-income, low-incidence (HILI) countries like the UK, its prevalence, influence, and lived impact remain largely unexplored. Where stigma appears in research, it is often treated as an emerging theme, leaving a critical gap in understanding how individuals with TB, or those caring or supporting them, experience and respond to it.\n\nThis study adopts a Constructivist Grounded Theory (CGT) approach to examine TB-related stigma in depth. CGT allows the research to explore how people living with TB make sense of, interpret, negotiate, and resist stigma, capturing the dynamic and contextual ways it shapes their lives, identities, and interactions with healthcare systems. By investigating these meaning-making processes, the study aims to illuminate how stigma operates in the UK, providing insights to inform future stigma-reduction interventions, communication strategies, and supportive healthcare practices, ultimately benefiting patients, communities, and the NHS.",[131,25,407,408,409],"Stigma","TB Stigma","Low Incidence",[131,25,407,411,401],"Low incidence","2026-05-21",{"date":414,"type":34},"2026-05-27",{"date":416,"type":21},"2026-09-01",{"date":418,"type":21},"2028-03-01",{"name":420,"class":41},"Bournemouth University",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":429,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":85,"phases":432,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":447},"100433425","rapid-research-in-diagnostics-development-for-tb-network-100433425","NCT04923958","Rapid Research in Diagnostics Development for TB Network","Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study","R2D2TB Network","Novel TB triage and diagnostic tests:\n\nWe will include non-hospitalized adults (age ≥ 12 years) with either 1) cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups or 2) risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below:\n\nPositive TB screening definitions by risk factor:\n\n1. PLHIV (Risk Factor), CRP \\>5 mg\u002FdL OR abnormal CXR (Positive TB screening definition)\n2. Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)\n3. History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition)\n\nWe will exclude people who:\n\n1. completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);\n2. have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives);\n3. reside \\>20km from the study site or are unwilling to return for follow-up visits; or\n4. are unwilling to provide informed consent\n\nNovel TB rDST assays:\n\nWe will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB\u002FRIF, Xpert MTB\u002FRIF Ultra, or Hain MTBDRplus). We will exclude people who:\n\n1. have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures\n2. are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment\n3. are unable or unwilling to provide informed consent\n\nAssessment of the usability of novel TB tests:\n\nWe will include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). We will exclude staff who are unwilling to provide informed consent.","12 Years",{"count":431,"type":21},26436,[433],"NA","To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.",[25],[25,437,438],"Diagnostics","Global Health","2026-05-04",{"date":252,"type":34},{"date":442,"type":34},"2021-04-14",{"date":444,"type":21},"2031-05-31",{"name":446,"class":41},"University of California, San Francisco",16,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":17,"minAge":429,"maxAge":4,"enrollmentInfo":456,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":458,"conditions":459,"keywords":460,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":42},"100463634","cough-audio-classification-as-a-tb-triage-test-100463634","NCT05317247","Cough Audio Classification as a TB Triage Test","Automated Smartphone-based Cough Audio Classification for Rapid Tuberculosis Triage Testing (Cough Audio triaGE for TB; CAGE-TB)","CAGE-TB","Inclusion Criteria:\n\n* participant must be at least 12 years old\n* participant must have a prolonged cough (for at least two weeks)\n* participant must provide informed consent\n* participant shall have a known HIV status or be willing to undergo standard of care HIV testing and counseling\n\nExclusion Criteria:\n\n* individuals who refuse informed consent\n* individuals who have received treatment for TB in the 60 days prior to enrolment\n* individuals who are unable to provide a sputum specimen for microbiological testing\n* individuals who have haemoptysis or a bloody cough with any forced coughs for audio recordings",{"count":457,"type":21},1751,"TB is the single biggest infectious cause of death (1.5 million died in 2018), killing more HIV-positive people than any other disease, and is arguably the most important poverty-related disease in the world. TB's estimated incidence in Africa has been declining over recent years but progress is slow and plateauing. To avert stagnation, truly innovative and ambitious technologies are needed, especially those that improve case finding and time-to-diagnosis as, in mathematical models based on the TB care cascade framework, interventions that accomplish this will have the most impact on disrupting population-level transmission, including when deployed at facilities where patients are readily accessible. Critically, these interventions (triage tests) must promote access to confirmatory testing (e.g., Xpert MTB\u002FRIF Ultra) by enabling patients to be referred rapidly and efficiently during the same visit. The investigators will optimise and evaluate a technology that, aside from the investigators early case-controlled study to show feasibility, is hitherto not meaningfully investigated for TB. This gap is alarming given, on one hand, the enormity of the TB epidemic and the need for a triage test and, on the other hand, promising proofs-of-concept that demonstrate high diagnostic accuracy of cough audio classifier for respiratory diseases such as pneumonia, asthma. pertussis, croup, and COPD. In some cases, these classification systems are CE-marked, awaiting FDA-approval, and subject to late-stage clinical trials. This demonstrates the promise of the underlying technological principle. CAGE-TB's innovation is further enhanced by: applying advanced machine learning methods that the team have specifically developed for TB patient cough audio analysis, use of mixed methods research - drawing from health economics, implementation science, and medical anthropology - to inform product design and assess barriers and facilitators to implementation, and uniquely for a TB diagnostic test, its potential deployment as a pure mHealth (smartphone-based) innovation that mitigates many barriers that typically jeopardise TPP criteria fulfilment.",[25],[461,462,463],"Triage","Cough audio classification","Smartphone application","2026-04-29",{"date":252,"type":34},{"date":467,"type":34},"2022-04-19",{"date":469,"type":21},"2027-12-30",{"name":471,"class":41},"University of Stellenbosch",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":481,"conditions":482,"keywords":483,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":42},"100366496","paradoxical-tuberculosis-reactions-in-patients-without-hiv-infection-100366496","NCT04052022","Paradoxical Tuberculosis Reactions in Patients Without HIV Infection","* INCLUSION CRITERIA:\n\nSuspected Paradoxical Reaction Group Criteria:\n\n1. Aged greater than or equal to 18 years.\n2. Diagnosed with confirmed (microbiologically or with molecular methods) or suspected (clinical plus or minus histologic diagnosis) TB and currently on ATT for a minimum of 2 weeks, or have completed ATT, with at least 2 of the following signs\u002Fsymptoms of a paradoxical inflammatory reaction:\n\n   * Recrudescent symptoms of TB after initial clinical improvement.\n   * Change in physical exam after initial clinical improvement suggestive of new inflammatory process (e.g., lymphadenopathy or new findings on pulmonary exam).\n   * Worsening radiographic evidence of disease after initiation of treatment, as compared with imaging prior to or earlier in treatment.\n   * Laboratory evidence of acute inflammatory response, including the development of leukocytosis (white blood cell count \\> 10,000 cells\u002FmicroL) or a change of C-reactive protein (CRP) \\> 5 mg\u002FL compared to prior laboratory values.\n   * Worsened organ function after initial clinical improvement.\n3. The above sign\u002Fsymptom(s) cannot be explained by a newly acquired infection, clinical course of a previously recognized infectious agent, side effects of the ATT, the presence of drug resistance, or any other condition except for paradoxical reaction.\n4. Willingness to allow storage of blood or tissue samples for future research.\n5. Ability of participant to understand study requirements and give informed consent.\n6. Has a primary care physician and is being followed by the local Department of Health for their TB (or has plans to arrange after enrollment if enrolled early in course from inpatient transfer).\n\nControl Group Criteria:\n\n1. Aged greater than or equal to 18 years.\n2. Diagnosed with confirmed (microbiologically or with molecular methods) or suspected (clinical plus or minus histologic diagnosis) TB.\n3. Presenting 2 to 4 months after starting ATT to match timing of paradoxical reactions.\n4. Willingness to allow storage of blood or tissue samples for future research.\n5. Ability of participant to understand study requirements and give informed consent.\n6. Has a primary care physician and is being followed by the Department of Health for their TB (or has plans to arrange after enrollment if enrolled early in course from inpatient transfer).\n\nEXCLUSION CRITERIA:\n\nIndividuals in either group who meet any of the following criteria will be excluded from study participation:\n\n1. HIV infection. (Individuals with HIV infection may be eligible for a separate study exclusively evaluating persons living with HIV.)\n2. Pregnant or breastfeeding.\n3. Uncontrolled psychiatric disease, substance use, or inappropriate conduct unsuitable for a research study.\n4. Malignancy requiring imminent or ongoing treatment including radiation, chemotherapy, or immunotherapy.\n5. Debilitating or chronic conditions that would limit ability to participate in the study.\n6. Emergent or urgent clinical conditions not due to studied disease of interest requiring immediate treatment that would be unsuitable for a research study. These patients would be transferred to an emergency room and able to rescreen when condition has been stabilized.","99 Years",{"count":480,"type":21},140,"Background:\n\nMost people with tuberculosis (TB) feel better after starting treatment. But for some people, the opposite happens. They may feel better at first, but then suddenly get worse. This is a paradoxical reaction. Researchers want to better understand what causes this reaction and what happens after someone has it.\n\nObjective:\n\nTo learn about paradoxical reactions to TB treatment.\n\nEligibility:\n\nAdults 18 and older diagnosed with confirmed or suspected TB and currently on treatment for at least 2 weeks, with or without signs\u002Fsymptoms of a paradoxical inflammatory reaction.\n\nDesign:\n\nParticipants will be screened with a physical exam and medical history. They will give blood and urine samples.\n\nEligible participants will visit either the NIH Clinical Center or the Mexico Clinic sites 3 times over 6 to 18 months. Each visit will take 7 hours to complete; visits may be scheduled over more than 1 day. Participants may have more visits if their TB symptoms change.\n\nParticipants will give blood, urine, and sputum samples. They will have adverse event assessments. They will have 2 to 3 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) scans. PET\u002FCT scans make pictures of the inside of the body. For this, participants will lie on a table that slides into a donut-shaped scanner. They will get a small amount of radioactive dye through an IV, which is a small plastic tube placed in a vein in the arm using a needle.\n\nParticipants may have optional apheresis at the NIH site only. For this, blood is taken from a needle in one arm. White blood cells are separated from the rest of the blood. The rest of the blood is returned through a needle in the other arm.",[25],[484,485,486,487,488,135],"Auto-Antibody Production","Host Genetic Predisposition","Immune Reconstitution Inflammatory Syndrome","Biomarkers","Pathogenesis",{"date":490,"type":34},"2026-04-30",{"date":492,"type":34},"2019-12-20",{"date":494,"type":21},"2029-04-30",{"name":141,"class":142},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":85,"phases":505,"briefSummary":506,"conditions":507,"keywords":508,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":514,"leadSponsor":516,"locationsCount":112},"100569577","hospital-and-extra-hospital-nursing-care-for-tuberculosis-100569577","NCT06696053","Hospital and Extra-hospital Nursing Care for Tuberculosis","FOLLOWTUB","Inclusion Criteria:\n\n* Patient for whom a diagnosis of tuberculosis disease or latent tuberculosis according to the recommendations of the IDSA \u002F CDC has been made and treatment with antituberculosis drugs started less than 3 weeks ago (9)\n* Patient followed in one of the participating departments of the St Antoine hospital (internal medicine, rheumatology, gastroenterology, hepatology, geriatrics)\n* Patient having signed informed consent\n* Patient whose age \\> 18 years\n* Patient affiliated to a social security scheme\n\nExclusion Criteria:\n\n* Patient under legal protection",{"count":504,"type":21},40,[433],"The incidence of tuberculosis has decreased over the last 2 years on the national territory (6.4\u002F100,000 inhabitants) but remains twice as high in Ile de France where it is increasing with an increase of almost 10% in the number of cases. reported between 2015 and 2017 . the notification rate of tuberculosis disease for the year 2020 was 14.3 cases per 100,000 inhabitants (i.e. 1757 cases declared) which is more than double that found at the national level . As the disease is multifocal, patients are likely to be hospitalized in different departments with variable care and compliance support offered. One of the major issues is compliance with treatment. Indeed, INVS data (2008-2014) report a percentage of treatment completed in pulmonary tuberculosis of 73% . Among these cases, 20% had a potentially unfavorable outcome, including 45% lost to follow-up, which creates a risk of relapse and contagiousness for those around them. The latest data reported in 2022 over the period 2014-2018 seem to show an increase in treatment completeness but completeness remains variable from one region to another and from one year to another Using Public Health France data, the investigator were able to collect the proportion of completeness of treatment at Saint Antoine hospital, which is 60% over the period 2014-2016 (Public Health France, unpublished data). In more recent work carried out within the department retrospectively between 2019-2021, the investigator compared treatment outcomes depending on whether or not patients benefit from ETP support and it is 66% among patients without it. benefited, thus confirming the data from Public Health France over a more recent period.. In this context, several other studies have shown the interest of a therapeutic education program on the completeness of the treatment.",[25],[25,509],"education nursing program","2026-04-23",{"date":512,"type":34},"2026-04-24",{"date":165,"type":21},{"date":515,"type":21},"2027-09",{"name":517,"class":41},"Assistance Publique - Hôpitaux de Paris",{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":524,"eligibilityCriteria":525,"healthyVolunteers":265,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":526,"targetDuration":528,"studyType":22,"phases":4,"briefSummary":529,"conditions":530,"keywords":531,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":42},"100606068","quantitative-measurement-of-plasma-and-urine-mtb-cell-free-dna-level-100606068","NCT07170735","Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level","Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level in Diagnosing TB and Treatment Monitoring","LIQUID-TB","Inclusion Criteria:\n\n* TB group: patients hospitalized for newly diagnosed TB disease.\n* LTBI group: patients without TB disease, but with LTBI diagnosed by either tuberculin skin test (TST) or an interferon-gamma release assay (IGRA) blood test.\n* Control group: patients or healthy volunteers without TB disease and LTBI\n\nExclusion Criteria:\n\n* Initiation of an effective anti-TB treatment regimen more than 24 hours\n* Aged 17 years or younger\n* Life expectancy of less than 12 months",{"count":527,"type":21},85,"12 Months","Tuberculosis (TB) is one of the leading causes of infectious disease worldwide. The diagnosis of TB typically relies on microbiological evidence of the presence of Mycobacterium tuberculosis (MTB) or histological features of the host immune response to MTB in the infected organs. The diagnosis can be enhanced by performing molecular diagnostic tests (e.g. polymerase chain reaction, PCR) on the clinical specimens obtained. Expectorated sputum is usually the first sample sent for MTB culture for suspected pulmonary TB (PTB), which is the most common type of TB. However, this can be particularly challenging for paediatric patients and elderly patients with poor coughing techniques or effort. While for extrapulmonary TB (EPTB), which contributes to 10-20% of TB cases, with TB pleuritis and lymphadenitis as the most common types, invasive investigations are usually required for obtaining clinical specimens of good quality for MTB culture or histological examination. The invasiveness of procedures (e.g. pleural biopsy, lymph node biopsy) and inadequate sensitivity of diagnostic tests could hinder the diagnosis of EPTB. The long turnaround time of MTB culture also creates a challenge for timely diagnosis. Blood sampling for MTB culture or PCR, although non-invasive, has low diagnostic yields. All these urges for non-invasive, rapid and accurate diagnosis of TB.\n\nThe standard duration of TB treatment is 6 months, with a longer duration up to 12 months required for certain types of EPTB or in patients with underlying comorbidities (e.g. diabetes mellitus). Treatment monitoring and surveillance for relapses are typically based on a composite of clinical symptoms, sputum MTB culture status, and radiographical appearance. All these domains have their drawbacks, including subjective reporting (clinical symptoms), long turnaround times (sputum MTB culture status), and a lack of diagnostic sensitivity (changes in radiographical appearance in PTB). These clinical unmet needs may be overcome if a non-invasive molecular test could accurately quantify the burden of MTB in the body. Recently, it was reported that the level of MTB cfDNA in plasma can be measured by the CRISPR-TB assay. However, the data were derived mainly from the paediatric patient group and did not evaluate the possibility of latent TB infection (LTBI). This new technology remains explorative at the moment.\n\nOur group has developed a metagenomic sequencing-based assay for measuring the level of MTB cell-free DNA (cfDNA) in plasma. We hypothesize that this new plasma MTB cfDNA assay has the potential to diagnose active TB disease, treatment monitoring and surveillance monitoring by serially measuring the MTB cfDNA level in the plasma. Similar technology may also be applicable to urine, which requires prospective validation.",[25],[25],"2026-04-21",{"date":512,"type":34},{"date":535,"type":34},"2026-02-01",{"date":537,"type":21},"2027-07-31",{"name":539,"class":41},"Chinese University of Hong Kong",{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":265,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":548,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":112},"100483184","immunogenicity-of-covid-19-vaccines-in-tuberculosis-patients-100483184","NCT05571735","Immunogenicity of COVID-19 Vaccines in Tuberculosis Patients","Immunogenicity of COVID-19 Vaccines Against Coronavirus Disease (COVID-19) Among Tuberculosis (TB) Patients in Thailand-Myanmar Border.","CVTB","Inclusion Criteria:\n\n* 18 years and above, newly diagnosed bacteriologically confirmed TB patients including both drug sensitive and resistant TB, who are taking anti TB or MDR-TB treatment in initial period during study period or clinically healthy individuals for comparator arm.\n* Willing to be followed for four weeks following second dose of Pfizer-BioNTech COVID-19 vaccine and AstraZeneca vaccine or eight weeks following single dose of Janssen Ad26.COV2.S COVID-19 vaccine\n* Willing to be involved in the pre-enrolment screening.\n* For women with child bearing potential only (aged 18-49 years), willing to continue to use effective contraception methods through the study.\n* For women with child bearing potential only (aged 18-49 years), negative pregnancy test on the day of screening and on the day of vaccination to be eligible to receive the vaccination.\n* Able and willing to comply with all study requirements.\n* Ability to understand the study instructions and provide written informed consent\n\nExclusion Criteria:\n\n* History of laboratory confirmed COVID-19 for any duration before or positive COVID-19 PCR or antigenic test at screening.\n* History of HIV infection\n* Participation in other COVID-19 related studies for the duration of the study.\n* Participation in other vaccine trials within 90 days before and 30 days after the study vaccination.\n* Administration of any immunoglobulins or any type of COVID-19 vaccine within 90 days before administration of the vaccine.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Any previous history of a serious side effect with any kind of vaccine.\n* Any history of angioedema.\n* Any history of anaphylaxis.\n* Women with pregnancy, lactation or planning to get pregnant during the duration of the study.\n* Current diagnosis of or treatment for cancer.\n* History of severe psychiatric disorders likely to affect participation in the study.\n* Bleeding disorder (e.g. coagulation factor deficiency, coagulopathy or platelet disorder), history of thrombosis or prior history of significant bleeding or bruising following IM injections or venipuncture.\n* Suspected or known current alcohol or drug dependency (except well controlled condition).\n* Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study.\n* Severe and\u002For uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild\u002Fmoderate well controlled comorbidities are allowed).",{"count":549,"type":21},133,"This study is a non-randomized observation and comparison of immune response between bacteriologically confirmed TB patients under treatment cohort who received COVID-19 vaccine (n=54) vs healthy individuals (n=54).\n\nEach participant will receive single or double doses of one of COVID-19 vaccines (Pfizer-BioNTech COVID-19 vaccine, AstraZeneca vaccine or Janssen Ad26.COV2.S COVID-19 vaccine) in the deltoid muscle of the non-dominant arm. Study Duration approximately 1 year. The main focus of this study is to compare the humoral and cellular immunological responses of the COVID-19 vaccines between bacteriologically confirmed TB patients under treatment vs healthy individuals.\n\nThis study is funded by the Wellcome Trust. The grant reference number is 220211\u002FA\u002F20\u002FZ.",[552,25],"Covid-19 Pandemics","2026-04-07",{"date":555,"type":34},"2026-04-13",{"date":557,"type":34},"2023-04-15",{"date":559,"type":21},"2026-06-30",{"name":561,"class":41},"University of Oxford",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":569,"targetDuration":4,"studyType":85,"phases":571,"briefSummary":572,"conditions":573,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":112},"100503968","south-africa-smoking-cessation-and-engagement-in-hivtb-care-care-100503968","NCT05842161","South Africa Smoking Cessation and Engagement in HIV\u002FTB Care Care","Treatment Development for Smoking Cessation and Engagement in HIV\u002FTB","Inclusion Criteria:\n\n1. Aged 18 or older\n2. Willing and able to provide written informed consent\n3. Living with HIV, confirmed via medical record, and on antiretroviral therapy (ART) AND\u002FOR within 1 month of initiating or reinitiating TB treatment; positive GeneXpert test or sputum culture\n\n(5) Daily smoker operationalized as \\> 5 cigarettes per day, (6) Motivation (\\> 5\u002F10) to quit smoking or \\> 24 hour quit past yr\n\nExclusion Criteria:\n\n1. Habitual use of other tobacco products\n2. Current interfering untreated\u002Funstable mental health condition (e.g., psychosis, bipolar dx)\n3. Current use of non-study pharmacotherapy for smoking cessation,\n4. Cognitive Behavioral Therapy for smoking cessation initiated within the past year,\n5. Diagnosed with extra-pulmonary or drug resistant (MDR or XDR) TB based upon chart review",{"count":570,"type":21},86,[433],"The purpose of this study is to integrate elements from existing interventions developed by our team into a single intervention (QUIT-AD), designed to improve smoking cessation and favorable HIV\u002FTB treatment outcomes among individuals with HIV and\u002For TB in Cape Town, South Africa. If feasibility, acceptability, and preliminary efficacy are demonstrated, the intervention will be ready for large-scale effectiveness\u002Fimplementation testing. This program will has the potential to dramatically improve public health by increasing the smoking quit rate and facilitating favorable HIV\u002FTB treatment outcomes among patients with HIV and\u002For TB in resource limited South African settings.",[574,25,575],"HIV Infections","Smoking Cessation","2026-03-30",{"date":578,"type":34},"2026-04-06",{"date":580,"type":34},"2024-03-12",{"date":582,"type":21},"2026-05-31",{"name":584,"class":41},"Massachusetts General Hospital",{"id":586,"slug":587,"hasResults":12,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":591,"eligibilityCriteria":592,"healthyVolunteers":265,"sex":17,"minAge":4,"maxAge":593,"enrollmentInfo":594,"targetDuration":4,"studyType":85,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":199},"100561662","the-decide-tb-trial-validation-of-treatment-decision-algorithms-for-childhood-tuberculosis-100561662","NCT06593080","The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis","Validation of Treatment Decision Algorithms for Childhood Tuberculosis at District Health Care Levels in Mozambique and Zambia - the Decide-TB Cluster-randomized Pragmatic Trial","DTB","Inclusion Criteria:\n\nThe effectiveness assessment will be conducted using aggregated or individual data from direct beneficiaries of the intervention:\n\n* All sick children aged below 15 years entering the selected health facilities (DH and PHC) at either outpatient (OPD) or inpatient (IPD) departments, including children from high-risk groups, as well as children identified as contact of TB cases through community- or facility-based household contact tracing.\n* Children with presumptive TB.\n\nThe WHO definition of presumptive TB will be used, as defined in the 2022 WHO Operational Handbook, namely: children are classified as having presumptive TB if they have unremitting symptoms lasting more than 2 weeks (any one of cough, fever, not eating well or anorexia, weight loss or failure to thrive, fatigue, reduced playfulness or decreased activity) .\n\nThe definitions of presumptive TB have been adapted locally for the programmatic pilot. All children with presumptive TB as defined locally will be considered in the intervention and in secondary effectiveness and sub-group analyses.\n\nHigh-risk group will be defined using the definition in WHO-suggested TDAs A\\&B as children younger than 2 years, CLHIV or children with SAM. CLHIV will be defined per national testing strategy including positive PCR test for children below the age of 18 months. Children will be considered to have SAM (and thereby be eligible for the TB-Speed SAM algorithm) using WHO criteria. These include being \\\u003C5 years with a weight-for-height Z score (WHZ) \\\u003C -3 SDs or mid-upper arm circumference (MUAC) \\\u003C 115 mm (in children over 6 months) or clinical signs of bilateral pitting oedema, and being aged ≥5 years with a body mass index (BMI) for age Z-score \\\u003C -3SD.\n\nExclusion Criteria:\n\nThere will be no exclusion criteria for the programmatic pilot: all children will be offered the intervention.","14 Years",{"count":595,"type":21},30240,[433],"The Decide-TB project aims to generate evidence for the implementation of a comprehensive Treatment Decision Algorithms (TDA) based approach for TB in children living in high TB burden and resource-limited countries, at District Hospital (DH) and Primary Health Centre (PHC) levels, and to facilitate the integration of this evidence within practices and policies.\n\nThis programmatic pilot led by the National TB Programs (NTP) will test a TDA-based approach integrating TB screening, diagnosis, treatment decision-making, and disease severity assessment for shorter treatment eligibility, for use at a lower level of healthcare. This TDA-based approach will be evaluated in a hybrid effectiveness implementation study based on a pragmatic stepped wedge cluster-randomized trial. The Decide TB project will be implemented at the district level, targeting five districts in each country. Each cluster in a district will be made up of one district hospital and six primary health centers. The study will develop a Clinical Decision Support System (CDSS) to operationalize the use of TDAs, and strengthen District Health Information Systems (DHIS2) to collect individual data, which will contribute to monitoring and evaluation, clinical mentoring, and supervision by the country's NTPs.",[25,599,65,600],"Child Health","Severe Acute Malnutrition","2026-03-19",{"date":603,"type":34},"2026-03-24",{"date":605,"type":34},"2024-06-01",{"date":607,"type":21},"2027-08-31",{"name":609,"class":41},"Chishala Chabala",{"id":611,"slug":612,"hasResults":12,"nctId":613,"briefTitle":614,"officialTitle":615,"acronym":616,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":618,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":620,"conditions":621,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":4},"100630299","development-of-a-clinical-epidemiological-score-predictive-of-tuberculosis-100630299","NCT07485868","Development of a Clinical-epidemiological Score Predictive of Tuberculosis.","Creation of a Cohort of Patients With Tuberculosis or Suspected Tuberculosis Admitted to a University Hospital in a Low-endemic Setting, Development of a Clinical-epidemiological Score Predictive of Tuberculosis, Optimization of the Diagnostic-therapeutic Pathway.","SCORE-TB","Inclusion Criteria:\n\n* atients aged ≥18 years;\n* Patients hospitalized during the study period who, due to a clinical suspicion of tuberculosis, underwent diagnostic tests on respiratory samples (sputum, induced sputum, tracheal aspirate, bronchoalveolar lavage) at the Fondazione Policlinico Universitario \"A. Gemelli\" IRCCS.\n* Informed consent will be obtained for prospective patients, while for retrospective patients, reference will be made to Article 110-bis of the Privacy Code.\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years of age;\n* Patient already included (each patient will be included only once, regardless of the number of isolations).",{"count":619,"type":21},686,"Despite being a curable and preventable disease, tuberculosis still represents a major global health problem. It is estimated that 10.8 million people contracted tuberculosis in 2023, with an incidence of 134 per 100,000 inhabitants. In 2023, there were 1.25 million deaths, confirming this disease as a leading cause of death and the leading cause of death from a single infectious agent. It is a disease that primarily affects adults in their most productive years, with significant repercussions on family budgets. The aim of this study is to identify and characterize the demographic, epidemiological, microbiological, clinical, and radiological variables of the tuberculosis population that has come to our hospital's attention, as an exemplary population in a low-endemic setting. This study also aims to develop a tuberculosis risk score aimed at early differentiation between patients requiring respiratory isolation and those with negligible tuberculosis risk, and to improve diagnostic accuracy.",[25],"2026-03-17",{"date":624,"type":34},"2026-03-20",{"date":626,"type":21},"2026-04-01",{"date":628,"type":21},"2030-04-01",{"name":630,"class":41},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":85,"phases":640,"briefSummary":641,"conditions":642,"keywords":643,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":650,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":112},"100509728","peer-led-implementation-of-tb-hiv-education-and-adherence-counseling-in-uganda-100509728","NCT05917210","Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda","TEACH","Inclusion Criteria:\n\n* Age ≥18 years\n* Registered as a new, relapse, treatment failure, or previously lost-to-follow-up\n* TB case according to the on-site NTP TB Treatment Register\n* Screened and invited to participate within 30 days of TB treatment initiation\n\nExclusion Criteria:\n\n* Diagnosed with possible or confirmed drug-resistant TB\n* Transferring TB care into the clinic from an off-site facility\n* Residing \\>40 km from the enrolling clinic\n* Lacking mental capacity to provide informed consent",{"count":639,"type":21},1920,[433],"This cluster-randomized trial in Uganda will evaluate the effectiveness and implementation of a novel, peer-led TB education and counseling strategy to improve outcomes among persons with tuberculosis (TB) with and without HIV\u002FAIDS and assess the social-behavioral mechanisms underlying the observed treatment effects.",[25,65],[236,644,645,646,647,648,649],"hiv","implementation science","Uganda","Yale","Makerere","New York University",{"date":624,"type":34},{"date":652,"type":34},"2026-03-16",{"date":654,"type":21},"2028-10-16",{"name":656,"class":41},"Yale University",{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":662,"acronym":4,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":17,"minAge":664,"maxAge":593,"enrollmentInfo":665,"targetDuration":4,"studyType":85,"phases":667,"briefSummary":668,"conditions":669,"keywords":670,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":676,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":112},"100630193","effects-of-the-active-cycle-of-breathing-technique-with-and-without-balloon-blowing-therapy-in-tuberculosis-100630193","NCT07484490","Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis","Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy on Sputum Secretion, Dyspnea, and Functional Capacity in Children With Tuberculosis","Inclusion Criteria\n\n1. Children aged 8 to14 years\n2. Diagnosed with tuberculosis\n3. Patients with excessive pulmonary secretions and\u002For difficulty clearing airway secretions.\n4. Adequate cognitive ability to understand and follow verbal commands and perform ACBT.\n5. Informed consent from parent\u002Fguardian\n\nExclusion Criteria:\n\n1. Diagnosed with multi-drug-resistant (MDR) TB\n2. Presence of hemoptysis\n3. The patient who is unconscious and unresponsive.\n4. Received physical therapy intervention in the past 2 weeks","8 Years",{"count":666,"type":21},34,[433],"The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group or a control group. The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups.\" Dyspnea will be measured by the \"Modified Borg dyspne Scale,\" and functional capacity will be measured by the \"6-Minute Walk Test.\" Data will be analyzed through SPSS version 25.0.",[25],[671,672,673,674,675],"Sputum secretion","Dyspnea","Functional Capacity","Balloon blowing therapy","Active cycle of breathing",{"date":624,"type":34},{"date":678,"type":34},"2026-01-29",{"date":680,"type":21},"2026-08-30",{"name":682,"class":41},"Riphah International University"]