[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tuberculosis-pulmonary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tuberculosis-pulmonary":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,45,76,88,135,160,184,205,225,248,280,305,326,348,376,402,423,451,476,500,530,555,577,598],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100053455","phase-4-the-lalelalung-study-digital-stethoscope-clinical-evaluation-100053455",false,"NCT07631377","The LalelaLung Study: Digital Stethoscope Clinical Evaluation","LaLeLa","Inclusion Criteria:\n\n* Age 2 to 59 months at the time of screening\n* Presence of cough and\u002For difficulty breathing\n* No WHO-defined emergency\u002Fdanger signs (e.g., grunting, cyanosis, apnea, convulsions, or altered level of consciousness)\n* A legal caregiver is present, able to understand the study information, and willing to provide written informed consent\n* Caregiver is willing and able to provide contact information (e.g., mobile phone number) to allow 7-day follow-up after the clinic visit\n\nExclusion Criteria:\n\n* Presence of WHO-defined emergency signs requiring immediate referral or hospital admission (grunting, cyanosis, apnea, uncompensated shock, convulsions, diarrhea with severe dehydration, or altered level of consciousness)\n* Critical illness or clinical instability judged by the screening clinician or study physician to require urgent medical attention\n* Age outside the target range (younger than 2 months or older than 59 months)\n* Previous enrollment in the study\n* Refusal or withdrawal of informed consent by the legal caregiver at any time prior to randomization","ALL","2 Months","59 Months",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Pneumonia is the leading infectious cause of death in children under five years of age worldwide, and most of these deaths occur in low- and middle-income countries. In these settings, frontline health workers diagnose pneumonia using the World Health Organization's Integrated Management of Childhood Illness (IMCI) guidelines, which rely mainly on counting how fast a child is breathing and checking for chest indrawing. This approach has saved many lives, but it is not very specific. As a result, many children who actually have self-limiting viral illnesses that do not require antibiotics are nonetheless treated with antibiotics, contributing to the global rise of antimicrobial resistance.\n\nNew digital stethoscopes paired with artificial intelligence (AI) can record a child's lung sounds and automatically detect abnormal sounds such as crackles and wheezes with accuracy comparable to physicians. The LaLeLa Lung Study will evaluate whether adding an AI-enabled digital stethoscope to standard IMCI assessment improves the accuracy of pneumonia diagnosis among children aged 2 to 59 months who present with cough and\u002For difficult breathing at a primary care clinic in Cape Town, South Africa.\n\nThe main component (Objective 1) is a randomized, triple-blinded diagnostic accuracy study that will enroll 350 children, randomly assigned in a 1:1 ratio to either IMCI care enhanced by the AI-enabled digital stethoscope or standard IMCI care. An independent panel of physicians, blinded to the AI results and to study-arm assignment, will review each case and serve as the reference standard for determining whether pneumonia was truly present. The investigators hypothesize that IMCI enhanced by the AI stethoscope will diagnose pneumonia more accurately, and target antibiotics more appropriately, than standard IMCI alone. Nested sub-studies will additionally evaluate a second AI stethoscope for tuberculosis detection, a wearable lung-sound and respiratory-rate patch, an automated respiratory-rate monitor, and a smartphone-connected pulse oximeter.\n\nA separate component (Objective 2) is a mixed-methods implementation study at a second clinic that will assess how easily health workers can use these devices, how acceptable the devices are to health workers and caregivers, and how well the devices fit into routine clinic workflows.\n\nThroughout the study, all AI-generated results will remain concealed from clinic staff, study clinicians, and caregivers, so the AI-generated results will not influence the care any child receives. All children continue to receive standard IMCI care. Findings will help inform whether AI-enabled digital auscultation should be integrated into childhood pneumonia care in South Africa and similar low-resource settings, with the goal of improving diagnosis, strengthening antibiotic stewardship, and reducing antimicrobial resistance and child mortality.",[27,28,29,30,31,32],"Pneumonia","Tuberculosis, Pulmonary","Respiratory Tract Infections","Bronchiolitis","Respiratory Sounds","Antibiotic Resistant Strain","NOT_YET_RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":21},"2026-08-17",{"date":41,"type":21},"2028-06-30",{"name":43,"class":44},"Johns Hopkins University","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100644546","phase-2-sorfequiline-based-regimens-in-adults-with-newly-diagnosed-drug-sensitive-pulmonary-tb-100644546","NCT07672405","Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TB","A Phase 2b, Randomised, Multi-center, Partially Blinded Trial Assessing the Safety and Efficacy of Regimens Containing Sorfequiline, Pretomanid and Linezolid in Adults With Newly Diagnosed, Drug-sensitive, Smear Positive Pulmonary Tuberculosis","Inclusion Criteria:\n\n* DS-TB as defined as sensitive to rifampicin and isoniazid by rapid sputum-based test AND either newly diagnosed for TB or have a history of being untreated for at least 3 years after cure from a previous episode of TB\n* Of non-childbearing potential OR using effective birth control methods\n* Body weight ≥ 35 k\n\nExclusion Criteria:\n\n* Karnofsky score \\\u003C 60 at screening\n* Any evidence of extrapulmonary TB\n* Cardiovascular or QT prolongation risk factors Pregnant or breast-feeding\n* Laboratory abnormalities as defined in the protocol. • For participants living with HIV only:\n\n  * CD4+ count\\\u003C200 cells\u002FμL.\n  * WHO Clinical Stage 4 HIV disease\n  * Participant does not agree to use DTG\u002FTFV\u002F3TC during study treatment if ARV therapy is indicated\n  * If initiation of ARV therapy is indicated, participants who are known to be intolerant, non-responsive to DTG\u002FTFV\u002F3TC or have DTG\u002FTFV\u002F3TC as a contraindication.","18 Years","65 Years",{"count":55,"type":21},100,[57],"PHASE2","The goal of this interventional trial is to evaluate the safety and efficacy of the loading dose regimen 200\u002F100SPaL-4\u002F13 weeks, and the 100SPaL -17 weeks regimen in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis.\n\nParticipants (18-65 years) will be randomised 1:1, stratified by country and disease severity, to receive either :\n\n1. a sorfequiline loading-dose regimen (200 mg daily for 4 weeks followed by 100 mg daily for 13 weeks) plus pretomanid 200 mg and linezolid 600 mg daily, or\n2. sorfequiline 100 mg daily for 17 weeks plus pretomanid 200 mg and linezolid 600 mg daily. Study treatment is administered orally once daily with food.\n\nThe primary objective is to assess safety through 17 weeks of treatment, including treatment-emergent adverse events, ECG findings, vital signs, laboratory assessments, visual acuity, and peripheral neuropathy. Secondary objectives include assessments of efficacy (time to stable sputum culture conversion; favorable outcome and treatment failure\u002Frelapse at 26 and 52 weeks after end of treatment) and pharmacokinetics of trial drugs, with exploratory analyses including predictors of culture conversion, exposure-response relationships, and quality of life.",[28],[61,62,63,64,65],"tuberculosis","sorfequiline","drug sensitive tuberculosis","pretomanid","linezolid","2026-06-26",{"date":68,"type":37},"2026-06-30",{"date":70,"type":21},"2026-07-01",{"date":72,"type":21},"2028-06-24",{"name":74,"class":44},"Global Alliance for TB Drug Development",11,{"id":77,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":25,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":87,"locationsCount":4},"100643415",{"count":20,"type":21},[24],[27,28,29,30,31,32],"2026-06-05",{"date":83,"type":37},"2026-06-09",{"date":85,"type":21},"2026-07-20",{"date":41,"type":21},{"name":43,"class":44},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"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","9 Years",{"count":98,"type":21},860,[100],"PHASE3","While drug-susceptible tuberculosis (TB) disease in children currently requires four to six months of treatment, most children may be able to be cured with a shorter treatment of more powerful drugs. Shorter treatment may be easier for children to tolerate and finish as well as ease caregiver strain from managing treatment side effects and supporting children over many months. The primary objective of this study is to evaluate if a 2-month regimen (including isoniazid (H), rifapentine (P), pyrazinamide (Z) and moxifloxacin (M)) is as safe and effective as a 4- to 6-month regimen (isoniazid, rifampicin (R), pyrazinamide, ethambutol (E)) in curing drug-susceptible TB disease in children under 10 years old. The study is also evaluating the safety of the HPZM in children with and without HIV.",[103,28,104,105],"Tuberculosis","Tuberculosis, Lymph Node","Mycobacterium Tuberculosis",[61,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"pediatric","stratified medicine","shortened regimen","rifapentine","moxifloxacin","dolutegravir","drug-susceptible","lymph node","pulmonary","infections","TB","mycobacterium infections","respiratory tract infections","lung diseases","antitubercular agents","respiratory tract diseases","child","paediatric","RECRUITING","2026-05-28",{"date":128,"type":37},"2026-06-01",{"date":130,"type":37},"2025-01-15",{"date":132,"type":21},"2027-09-30",{"name":43,"class":44},9,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":143,"sex":16,"minAge":144,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100461174","clinic-based-versus-hotspot-focused-active-tb-case-finding-100461174","NCT05285202","Clinic-based Versus Hotspot-focused Active TB Case Finding","Clinic Versus Hotspot Active Case Finding and Linkage to Preventive Therapy (ACF\u002FTPT) Strategy Evaluation for TB: A Cluster-Randomized Crossover Trial","CHASE-TB","Inclusion Criteria:\n\n* Age ≥15 years, OR age 5-14 and a close contact of someone diagnosed with TB,\n* Provision of oral informed consent, or, if age \\\u003C18 years and not legally emancipated, oral informed assent (if ages 8-17) and parental informed consent (ages 5-17) to participate in the study\n* Ability to communicate with study staff in English or Luganda, or availability of a capable interpreter who is acceptable to the participant\n\nExclusion Criteria:\n\n* On treatment for, or diagnosed with but not yet treated for, active TB",true,"5 Years",{"count":146,"type":21},150000,[148],"NA","This five-year study will evaluate two strategies for conducting tuberculosis (TB) active case finding (ACF) and linkage to TB treatment or TB preventive therapy (TPT) in peri-urban Uganda. The two strategies differ in the location where ACF activities are performed: A \"facility-based\" ACF\u002FTPT strategy will perform ACF, plus linkage to TPT, in the immediate vicinity of a large public health facility and will primarily recruit individuals who are attending the health facility, irrespective of TB suspicion or symptoms. Alternatively, a \"hotspot-based\" strategy will use routine notification data and local expertise to identify local TB hotspots - defined as the geographic areas though to have the highest burden of undiagnosed TB per estimated population. The same infrastructure (personnel, equipment, supplies, etc.) for ACF\u002FTPT will then be placed in those zones for a period of four months at a time, and the general population will be recruited for screening and linkage to TPT.\n\nThe two interventions will be compared in a Type 1 hybrid effectiveness-implementation trial with a cluster-randomized, multiple-period crossover design. The study will evaluate whether hotspot-focused ACF\u002FTPT results in a greater number of TB patients diagnosed and linked to care, and a greater number of individuals started on preventive therapy, than facility-based ACF\u002FTPT. Secondarily, it will also compare the two interventions in terms of number of people initiated on TPT, and it will compare TB cases detected in regions performing ACF\u002FTPT (either approach) against cases detected in regions that continue to perform the standard of care.",[28,151],"Mycobacterium Tuberculosis Infection","2026-05-27",{"date":128,"type":37},{"date":155,"type":37},"2022-06-01",{"date":157,"type":21},"2026-11",{"name":43,"class":44},1,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":143,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":182,"locationsCount":159},"100581077","blood-tuberculosis-dna-levels-to-monitor-tuberculosis-treatment-100581077","NCT06845618","Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment","Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study","Mtb-Dynamic","Inclusion Criteria:\n\nParticipants with a new diagnosis of tuberculosis\n\n* Aged ≥ 18 years old\n* Newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of Mycobacterium tuberculosis (Mtb.) infection (of any site)\n* Has not yet commenced antituberculosis therapy\n* Able to understand study procedures and requirements and is able to give informed consent\n\nFor healthy volunteers:\n\n* Aged ≥ 18 years old\n* Healthy as judged by a responsible physician\n* Able to understand study procedures and requirements and is able to give informed consent\n\nExclusion Criteria:\n\nParticipants with a new diagnosis of tuberculosis\n\n* Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone)\n* Known history of underlying malignancy\n* Pregnancy\n* Transfusion dependent anaemia\n\nFor healthy volunteers:\n\n* History of tuberculosis infection or latent tuberculosis infection\n* Household, or other close contact, of a person living with tuberculosis disease\n* Chest radiograph (CXR) changes suggestive of pulmonary tuberculosis\n* Presence of symptoms which would otherwise indicate screening for tuberculosis (cough \\> 2 weeks duration, fever, weight loss, night sweats)\n* Other major medical comorbidity\n* Pregnancy\n* Known malignancy",{"count":169,"type":21},140,"OBSERVATIONAL","Tuberculosis (TB) is a leading infectious cause of death worldwide. Current strategies for monitoring TB treatment response are culture dependent and insensitive. New methods of assessing treatment response in vivo could inform new drug development and other treatment strategies. Cell-free DNA (cfDNA) - small circulating fragments of DNA - is widely used in maternofetal medicine and oncology for diagnosis and assessment of treatment response. This study aims to investigate whether pathogen derived Mycobacterium tuberculosis-specific cfDNA (Mtb-cfDNA) can be used to monitor TB treatment response.\n\nThis feasibility study will take place at Mae RaMat TB Center in Thailand and includes two study groups:\n\n1. Assay Development and Validation\n2. Longitudinal Assessment of Mtb-cfDNA levels",[105,28,173],"Tuberculosis, Extra-Pulmonary",[175],"cfDNA","2026-04-07",{"date":178,"type":37},"2026-04-13",{"date":180,"type":37},"2025-07-21",{"date":132,"type":21},{"name":183,"class":44},"University of Oxford",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":200,"leadSponsor":202,"locationsCount":4},"100531883","phase-2-therapeutic-id93--gla-se-vaccination-in-participants-with-rifampicin-susceptible-pulmonary-tb-100531883","NCT06205589","Therapeutic ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB","A Phase 2a\u002F2b Study Evaluating Safety, Immunogenicity, and Therapeutic Efficacy of ID93 + GLA-SE Vaccination in Participants With Rifampicin-Susceptible Pulmonary TB","Inclusion Criteria Groups 1-5:\n\n* Bacteriologically confirmed rifampicin-susceptible pulmonary TB using phenotypic drug susceptibility testing or a World Health Organization (WHO) approved molecular test.\n* Documentation of HIV status as positive or negative by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E\u002FCIA) test kit.\n* For individuals with HIV, on locally approved HIV ART for at least 90 days prior to entry.\n* For individuals with HIV, CD4+ cell count ≥250 cells\u002Fmm3 obtained within 90 days prior to entry at any network-approved non-US laboratory that is DAIDS IQA certified.\n* For individuals with HIV, HIV-1 RNA below the limit of detection obtained within 90 days prior to entry by any network-approved laboratory outside the US that operates in accordance with Good Clinical Laboratory Practices (GCLP) and participates in appropriate external quality assurance programs.\n* Laboratory values within the indicated ranges, obtained within 14 days prior to entry by any network-approved laboratory outside the US that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n\n  * Absolute neutrophil count (ANC) ≥800 cells\u002Fmm3\n  * Hemoglobin ≥8.5 g\u002FdL for candidates assigned female sex at birth and \\>9.0 g\u002FdL for candidates assigned male sex at birth\n  * Platelet count ≥100,000\u002Fmm3\n  * Serum creatinine ≤1.5 X upper limit of normal (ULN)\n  * AST (SGOT), ALT (SGPT), and alkaline phosphatase, ≤2.5 X ULN\n  * Total bilirubin ≤2 X ULN\n* For candidates who are able to become pregnant, negative serum or urine pregnancy test at or within 7 days prior to entry by any network-approved laboratory or clinic outside the US that operates in accordance with GCLP and participates in appropriate external quality assurance programs.\n* Candidates who are able to become pregnant must agree to use an adequate method of contraception (barrier methods or non-hormonal intrauterine device) or abstain from sexual activity that could lead to pregnancy from at least 21 days prior to the first scheduled vaccination through 90 days after last dose.\n* Candidates assigned female sex at birth (AFAB) must agree to not seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination, or in vitro fertilization, from at least 21 days prior to the first scheduled vaccination through 90 days after last dose.\n* For candidates who are not of child-bearing potential, acceptable documentation (written documentation or oral communication from a clinician or clinician's staff documented in source documents: physician report\u002Fletter, operative report or other source documentation in the candidate record, discharge summary, laboratory report, etc.) of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, vasectomy, or menopause.\n* Ability and willingness of candidate to provide informed consent.\n\nInclusion Criteria Groups 1 and 2 \\[Step 2\\]:\n\n* Documented duration of local SOC TB treatment prior to entry into Step 2 (study entry) for i. Group 1 of between 113 and 127 days (i.e., approximately 4 months of TB treatment) ii. Group 2 of between 83 and 97 days (i.e., approximately 3 months of TB treatment)\n\nInclusion Criteria, Groups 3, 4, and 5 \\[Step 1\\]:\n\n* Initiation of local SOC TB treatment within 7 days prior to entry into Step 1 (Study entry).\n\nExclusion Criteria Groups 1-5:\n\n* Documented M.tb resistance to isoniazid.\n* Breastfeeding.\n* Any previous episode of TB treatment.\n* TB treatment with a local non-standard first-line TB treatment regimen at time of enrollment.\n* Receipt of any investigational drug or any investigational non-TB vaccine since start of TB treatment.\n* Any prior receipt of any investigational TB vaccine.\n* Known allergy or any hypersensitivity to any components of study product or their formulation or any vaccination.\n* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.\n* History of moderate to serious autoimmune disease requiring immunosuppressive therapy.\n* Receipt of immunosuppressive medications (except as noted below) from start of TB treatment.\n\n  * Corticosteroid nasal spray\n  * Inhaled corticosteroids\n  * Topical corticosteroids for mild, uncomplicated dermatologic condition\n  * A single course of oral\u002Fparenteral prednisone or equivalent at doses \\\u003C60 mg\u002Fday and for \\\u003C11 days with completion at least 30 days prior to entry.\n* Receipt of Emergency Use Authorization (EUA)\u002FEmergency Use Listing (EUL) or licensed live attenuated vaccines (e.g., measles, mumps, and rubella \\[MMR\\], oral polio vaccine \\[OPV\\], varicella, yellow fever, live attenuated influenza vaccine, live attenuated COVID-19 vaccine) within 30 days prior to entry.\n* Receipt of any EUA\u002FEUL or licensed vaccines that are not live attenuated vaccines (e.g., tetanus, pneumococcal, Hepatitis A or B, not live attenuated COVID-19 vaccine) within 14 days prior to entry.\n* Receipt of immunoglobulin or blood-derived products within 90 days prior to entry.\n* History of angioedema, or anaphylaxis, except as noted.\n* History of generalized urticaria within past 5 years.\n* Malignancy, except as noted.\n* Daily (current) use of a short-acting rescue inhaler (e.g., a beta 2 agonist).\n* Within the previous year, exacerbation of asthma symptoms requiring emergency care, urgent care, hospitalization, or intubation.\n* Uncontrolled diabetes mellitus type 1 or type 2, defined as Hemoglobin A1c (HbA1C) \\>7%.\n* Bleeding disorder (e.g., factor deficiency, coagulopathy, platelet disorder requiring special precautions).\n* Seizure disorder, including either of the following within the previous 3 years:\n\n  * Seizure(s)\n  * Use of medications to prevent or treat seizure(s)\n* Acute or serious illness, including COVID-19, requiring systemic treatment and\u002For hospitalization from start of TB treatment, other than for pulmonary TB.\n* Documentation of clinically significant (as judged by the site investigator) active infections (including HIV-related opportunistic infections) other than TB and HIV requiring treatment within 30 days prior to entry.\n* Evidence of clinically significant disease (as judged by the site investigator) or any other abnormalities (other than the indication being studied) that would interfere with study product, procedures, or interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* Suspected or documented TB involving the central nervous system, renal TB or TB pericarditis, or current extrapulmonary TB involving other organ systems that might interfere with study product or procedures, as judged by the site investigator.\n* Contraindication to intramuscular injection in both deltoids.",{"count":192,"type":21},1500,[57],"This study is being done to test an experimental study vaccine compared to a placebo. The experimental study vaccine is called ID93 + GLA-SE. ID93 + GLA-SE has been used in humans in research but has not been approved for use in medical care. This study will be the first to test ID93 + GLA-SE in people living with HIV (PLWH). The injections during the study will be given to different groups of participants while they are using standard TB treatment. One of the research questions is to understand the differences in immune system responses depending on the timing of giving the injections after people begin taking standard TB treatment. Researchers also want to continue to look at whether the study vaccine is safe when tested in a larger group of people, and if getting the study vaccine in addition to standard TB treatment can help to lower the number of poor TB outcomes that people might have.",[28],"2026-04-06",{"date":198,"type":37},"2026-04-09",{"date":70,"type":21},{"date":201,"type":21},"2029-10-13",{"name":203,"class":204},"Advancing Clinical Therapeutics Globally for HIV\u002FAIDS and Other Infections","NETWORK",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":212,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":159},"100598878","18f-fibroblast-activation-protein-inhibitor-18f-fapi-74-in-tuberculosis-patients-100598878","NCT07077213","18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients","Biodistribution and Pathophysiology Study of 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients","Inclusion criteria: Patients may be enrolled into this protocol only if all the following inclusion criteria are met:\n\n* Greater than or equal to 18 years of age\n* Culture confirmation of M. tuberculosis, or sputum positive by molecular testing (GeneXpert).\n* Imaging evidence of suspected M. tuberculosis disease involving lung, and possible additional other sites of involvement. Modalities can include any imaging modality such as chest x-ray, CT, ultrasound, MRI, 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (\\[18F\\]FDG) PET\u002FCT, bone scan.\n* TB treatment initiation within 6-weeks by the time of the study PET\u002FCT scan OR within 6-weeks after receiving 6-months of TB treatments. Using this approach, we will be able to assess fibrosis in TB patients at treatment initiation as well as having received TB treatments. The same patient may be re-consented for a scan at the later time-point.\n* Subject is willing to give written informed consent.\n* Subject is willing and able to comply with the protocol for the duration of the study including undergoing scheduled visits and study procedures.\n* Screening clinical laboratory values must be within normal limits or judged not clinically significant by the investigator.\n* Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the radiotracer administration.\n* Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.\n\nExclusion criteria: Patients will be excluded from enrollment if any of the following apply:\n\n* Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and pharmacokinetics (PK) blood sampling, respectively)\n* Lactating females\n* Administered a radioisotope within 5 physical half-lives as part of a research study prior to study enrollment.\n* Determined to have prior (external) radiation exposure from research studies which will exceed Radioactive Drug Research Committee (RDRC) annual radiation exposure limit of 5 rems.\n* Any medical condition that in the judgment of the investigator would make the patient inappropriate for entry into this study.",{"count":213,"type":21},30,"The investigators will assess the hypothesis is that 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) Positron emission tomography (PET) could be used as a noninvasive biomarker to assess post-tuberculosis (post-TB) lung disease and fibrosis in TB patients.\n\nMicrobiologically confirmed patients with active tuberculosis will be invited to participate in the study. A whole-body PET scan will be performed after 18F-FAPI-74 intravenous injection and correlation will be made with sites of TB lesions noted on CT. It is anticipated that 18F-FAPI-74 PET will be able to detect fibrosis (with high sensitivity) in the TB lesions.",[28],"2026-03-26",{"date":218,"type":37},"2026-03-31",{"date":220,"type":37},"2026-03-12",{"date":222,"type":21},"2027-12-01",{"name":224,"class":44},"Children's Hospital Medical Center, Cincinnati",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":22,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100520511","phase-3-pragmatic-optimized-rifampicin-trial-100520511","NCT06057519","Pragmatic Optimized Rifampicin Trial","Pragmatic Trial on the Safety and Tolerability of an Optimized Dose of Rifampicin in Tuberculosis Patients","PORT","Inclusion Criteria:\n\n* The patient has provided informed consent for study participation prior to all trial-related procedures.\n* The patient has a diagnosis of pulmonary tuberculosis according to the local diagnostic criteria.\n* The patient is aged 18 years or older at the day of informed consent.\n* No known allergic reactions or toxicity to rifampicin in the past.\n* Female patients of childbearing potential must have a negative serum pregnancy test, and consent to practice an effective method of birth control during the study. And they should not be lactating during the trial (female participants of childbearing potential only). Effective birth control for female patients has to include two methods, including methods that the patient's sexual partner(s) use. At least one must be a barrier method. Female patients are considered not to be of childbearing potential if they are post-menopausal with no menses for the last 12 months, or surgically sterile (this condition is fulfilled by bilateral oophorectomy, hysterectomy, and by tubal ligation which is done at least 12 months prior to enrolment).\n* The patient will be compliant to the study schedule, in the discretion of the investigator.\n\nExclusion Criteria:\n\n* The patient has tuberculosis which is assessed to receive high dose rifampicin according to the local standard of care.\n* The patient started current TB treatment more than 4 weeks ago.\n* The patient has TB meningitis.\n* The patient is in a coma.\n* Circumstances that raise doubt about free, uncoerced consent to study participation (e.g. in a prisoner or mentally handicapped person)\n* The patient is not able to give consent personally.\n* Poor general condition or comorbidities where delay in treatment cannot be tolerated or death within three months is likely. Or if there is concurrent treatment that may interfere.\n* The patient is pregnant or breast-feeding.\n* Patient infected with a rifampicin-resistant strain of M. tuberculosis.\n* Known allergy or intolerance for rifamycins.\n* The participant has a known or suspected, current alcohol or drug or amphetamine abuse, that is, in the opinion of the investigator, sufficient to compromise the safety or cooperation of the patient.\n* The patient has a known allergy or intolerance, or concomitant disorders or conditions for which rifamycins or other standard TB treatment drugs are contraindicated.\n* The patient has had treatment with any other investigational drug within 1 month prior to enrolment, or enrolment into other clinical (intervention) trials is planned in the upcoming 6 months\n* Laboratory: at screening one or more of the following abnormalities were observed for the patient in screening laboratory:\n\n  * Serum amino aspartate transferase (AST) and\u002For serum alanine aminotransferase (ALT) activity \\>3x the upper limit of normal\n  * Serum total bilirubin level \\>2.5 times the upper limit of normal\n  * Creatinine clearance (CrCl) level lower than 30 mls\u002Fmin\n* Acute or severe or life-threatening liver disease induced by drugs in the past\n* The patient has a chronic disorder such as liver disease or renal disease.\n* The patient has icterus.\n* Previous anti-TB treatment: the patient ended a previous TB treatment (episode) within last 3 months.",{"count":234,"type":21},164,[100],"The goal of this clinical trial is to compare an optimized dose (1800 mg) of rifampicin to standard dose (450 mg if patient \\\u003C50 kg and 600 mg if patient \\>50kg) of rifampicin in tuberculosis patients.\n\nThe main questions it aims to answer are:\n\n* To compare the incidence of hepatotoxicity occurs in the optimized dose vs standard dose arm\n* To compare any adverse events occur in the optimized dose vs standard dose arm\n* To compare final treatment outcome at the end of treatment according to WHO definitions of cure in the optimized dose regimen versus the standard dose regimen.\n* To compare two and three months culture conversion rates in the optimized dose regimen versus the standard dose regimen.\n* To describe and compare the steady-state plasma pharmacokinetics of the optimized dose regimen versus the standard dose regimen.\n\nParticipants will be given an optimized dose of 1800 mg of rifampicin daily. Researchers will compare the optimized and standard dose to see if more hepatotoxicity occurs.",[28],"2026-01-16",{"date":240,"type":37},"2026-01-21",{"date":242,"type":37},"2024-01-16",{"date":244,"type":21},"2026-12-31",{"name":246,"class":44},"Radboud University Medical Center",2,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":22,"phases":259,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100549972","phase-2-program-for-rifampicin-resistant-disease-with-stratified-medicine-for-tuberculosis-100549972","NCT06441006","Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis","Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)","PRISM-TB","Inclusion Criteria:\n\nAn individual must meet all of the following inclusion criteria at the time of enrollment in order to participate in this study:\n\n1. Confirmed fluoroquinolone-susceptible rifampicin-resistant pulmonary tuberculosis, based on sputum Xpert MTB\u002FRIF and Xpert MTB\u002FXDR, and\u002For other validated molecular test, and\u002For phenotypic drug susceptibility testing.\n\n   a. NOTE: TB diagnosis for purposes of meeting this inclusion criterion can be from a study testing laboratory or from an outside laboratory.\n2. Aged ≥ 14 years.\n3. A verifiable address or residence location that is readily available for visiting, willingness to consent to home visits and phone calls, and willingness to inform the study team of any change of address during the treatment and follow-up period.\n4. Ability and willingness of individual to provide written informed consent or written consent from a parent, guardian, or caregiver and assent of the child participant per local ethics committee guidance.\n5. Documentation of negative HIV infection status within 30 days prior to study entry or documentation confirming HIV infection at any time before study entry.\n6. For individuals with HIV: CD4+ cell count ≥ 50 cells\u002Fmm3 based on testing performed within 30 days prior to study entry.\n7. For individuals with HIV: Currently being treated with dolutegravir-based antiretroviral therapy (ART), or plan to initiate dolutegravir-based ART at or before study week 8.\n\n   a. NOTE: Dosing of ART and chemoprophylaxis for opportunistic infections should be reflective of local standard of care based on WHO or national guidelines. The following antiretrovirals are disallowed given significant drug-drug interactions with bedaquiline: efavirenz, etravirine, all protease inhibitors, and cobicistat-boosted elvitegravir. The following antiretroviral is disallowed given risk of myelosuppression with linezolid: zidovudine.\n8. For individuals who are pregnant: at screening, evidence by ultrasound of a viable singleton pregnancy with an estimated gestational age at enrollment of ≥ 14 weeks as per screening ultrasound.\n9. Chest radiograph obtained within 14 days prior to study entry.\n\nExclusion Criteria:\n\nAn individual meeting any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded from study participation:\n\n1. Known allergy\u002Fsensitivity, intolerance, or any hypersensitivity to components of study TB drugs or their formulation.\n2. One or more of the following laboratory parameters:\n\n   1. Absolute neutrophil count (ANC) \\\u003C 1000\u002Fmm3.\n   2. Hemoglobin level \\\u003C 8.0 g\u002FdL.\n   3. Serum or plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal.\n   4. Serum or plasma total bilirubin ≥ 3 times the upper limit of normal.\n   5. Serum or plasma creatinine level ≥ 3 times the upper limit of normal.\n   6. Evidence of laboratory values consistent with or equivalent to grade 4 toxicity (i.e., potentially life-threatening).\n   7. NOTE: Persons found not to be eligible due to laboratory abnormalities may be reevaluated within the screening window.\n3. QTcF interval ≥ 480 ms within 5 days prior to study entry.\n4. One or more risk factors for QT prolongation (apart from age and sex) or other uncorrected risk factors for torsades de pointes: evidence of ventricular pre-excitation (Wolff-Parkinson-White syndrome); electrocardiographic evidence of either complete left bundle branch block or right bundle branch block, or incomplete left bundle branch block or right bundle branch block and QRS complex duration ≥ 120 ms on at least one ECG; current pacemaker implant; congestive heart failure; evidence of second- or third-degree heart block; bradycardia defined by sinus rate less than 50 bpm; personal or family history of long QT syndrome; personal history of arrhythmic cardiac disease, with the exception of sinus arrhythmia; personal history of syncope (i.e., cardiac syncope not including syncope due to vasovagal or epileptic causes).\n5. Current grade 2 or higher peripheral neuropathy.\n\n   a. NOTE: Peripheral neuropathy assessment must be obtained within 7 days prior to study entry.\n6. Documentation of Karnofsky Performance Status Score \\\u003C 50 obtained within 14 days prior to study entry.\n7. Known resistance to bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolones.\n8. Previous use of any second-line anti-TB drugs for more than 14 days during the 12 months prior to the screening visit date.\n9. Known or presumed central nervous system TB, osteoarticular TB, or miliary\u002Fdisseminated TB in the current TB episode.\n10. Taking any medication that is contraindicated with study medicines which cannot be stopped (with or without replacement) or requires a washout period longer than 2 weeks.\n11. Any condition (social or medical or psychological) which, in the opinion of the investigator, would make participation unsafe or interfere with adherence to study requirements.\n12. Current enrollment in other therapeutic trials will not be eligible. a. NOTE: Current enrollment of index cases in prevention trials will be allowed on a case-by-case basis, provided that the prevention trial does not include a therapeutic intervention that could affect response to TB treatment.\n\nAll persons who are not eligible for the PRISM-TB trial will be managed according to local routine practice and may enroll in other studies.\n\nCriteria for Exclusion after Entry ('Late Exclusion'):\n\nEnrolled individuals who are subsequently determined to meet the following criteria will be classified as 'late exclusions' and study treatment will be discontinued:\n\n1\\. Bedaquiline, pretomanid, delamanid, linezolid, or fluoroquinolone resistance on phenotypic or molecular drug- susceptibility testing from samples collected up to 4 weeks after randomization.","14 Years",{"count":258,"type":21},400,[57,100],"PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2\u002F3 clinical trial for fluoroquinolone-susceptible multidrug-resistant\u002Frifampin-resistant pulmonary tuberculosis (FQ-S MDR\u002FRR-TB). In Stage 1, participants will be randomized among one of three treatment arms (one control and two experimental). Following the interim analysis (at the end of Stage 1) based on DOOR outcome comparisons and the entirety of the data, one of the four possible experimental strategies will be identified and continue into Stage 2. In Stage 2, participants will be randomized among one of two treatment arms (one control and one experimental).\n\nThe trial objective is to identify, among participants with fluoroquinolone-susceptible multidrug-resistant\u002Frifampicin-resistant tuberculosis (FQ-S MDR\u002FRR-TB), the preferred BPaLM strategy of 13 or 17 weeks for participants stratified to receive shorter treatment and 17 or 24 weeks for participants stratified to receive longer treatment, as defined by a prespecified stratification algorithm, and to evaluate whether this BPaLM strategy has noninferior efficacy to the control strategy at Week 73.",[28,262,263],"Tuberculosis, Multidrug-Resistant","Tuberculosis, MDR",[103,265,266,267,268,269],"BPaLM","Bedaquiline","Pretomanid","Linezolid","Moxifloxacin","2026-01-15",{"date":272,"type":37},"2026-01-20",{"date":274,"type":37},"2025-10-03",{"date":276,"type":21},"2031-08",{"name":278,"class":44},"University of California, San Francisco",6,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":22,"phases":290,"briefSummary":291,"conditions":292,"keywords":293,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":301,"leadSponsor":303,"locationsCount":4},"100617082","digital-health-intervention-to-improve-tpt-uptake-100617082","NCT07313995","Digital Health Intervention to Improve TPT Uptake","Digital Health Intervention in Improving Preventive Treatment Initiation and Completion Among Close Contacts of Tuberculosis Patients in South Ethiopia","DHiTPT","Inclusion Criteria:\n\n* All household and close contacts of drug-sensitive pulmonary TB patients\n* Living in the catchment area of the selected health facility\n* Willing to stay for at least 4 months in the catchment area\n\nExclusion Criteria:\n\n* Individuals with a known allergy to TPT drugs or those contraindicated for TPT drugs\n* Close contacts screened as symptomatic for TB\n* Close contacts with drug-resistant TB\n* Temporary residents staying for less than 4 months",{"count":289,"type":21},304,[148],"Despite the evidence of the prevention and control measures of tuberculosis (TB), it still has an impact on the health, social, and economic aspects of the population. Specifically, tuberculosis in children and newly diagnosed TB cases show there is current transmission of TB; to reduce this transmission and to attain the end TB strategy, preventing household TB transmission plays a great role. However, initiation and completion of TB preventive therapy (TPT) among close contacts of index TB patients are suboptimal. Some of the identified factors of low TPT initiation and completion are insufficient patient education, inadequate understanding of TPT, health professionals' perception, parental knowledge, and belief. The digital health intervention is currently being studied as a suggested health intervention that improves the utilization of health care services, including treatment adherence. A systematic review shows that TB treatment outcomes improved with the use of patient education, counseling, text reminders, and digital health technologies. However, other literature indicates controversial results, including our systematic review result, which identified that video directly observed therapy and text message (digital intervention) have no significant effect on TPT completion. In addition, the studies are scarce; therefore, this study aims to assess the effect of video-based education intervention combined with text message reminder (digital health intervention) in improving the initiation and completion of TPT among close contacts of drug-sensitive pulmonary TB patients in South Ethiopia.\n\nThe study hypothesizes that digital health intervention for close contacts of index drug-sensitive pulmonary TB patients will lead to higher TPT initiation and completion rates than standard care.",[28],[294,295,296],"Digital Health","TB preventive therapy","TPT initiation","2025-12-23",{"date":299,"type":37},"2026-01-02",{"date":270,"type":21},{"date":302,"type":21},"2026-06-20",{"name":304,"class":44},"Arba Minch University",{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":312,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":159},"100613794","safety-and-efficacy-of-ear-acupuncture-for-antituberculosis-drug-related-nausea-and-vomiting-100613794","NCT07271225","Safety and Efficacy of Ear Acupuncture for Antituberculosis Drug-Related Nausea and Vomiting","Effectiveness and Safety of Auricular Acupuncture for Nausea and Vomiting Side Effects Induced by Anti-Tuberculosis Drugs in Pulmonary TB Patients","Inclusion Criteria:\n\n* Participants are individuals diagnosed with drug-sensitive tuberculosis or drug-resistant tuberculosis receiving short-term treatment regimens (BPaL\u002FBPaLM)\n* Participants are aged 17 years or older.\n* Participants experience nausea and vomiting after taking antituberculosis drugs.\n* Participants are willing to comply with the study schedule until completion and provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of skin lesions at the site where press needles (PN) will be applied\n* Participants who experience nausea and vomiting prior to antituberculosis treatment (including comorbidities that may cause nausea and vomiting, such as renal failure and liver disorders)\n* Participants with drug-resistant tuberculosis (DR-TB) receiving long-term or individualized treatment regimens\n* Participants with diabetes mellitus and a random blood glucose level \\> 200 mg\u002FdL\n* Participants with unstable hemodynamic status\n* Participants who have received acupuncture therapy within the last 2 weeks\n* Participants with coagulation disorders (platelet count \\\u003C 50,000\u002FµL)\n* Participants with a history of hypersensitivity reactions to previous acupuncture treatment","17 Years",{"count":314,"type":21},58,[148],"This study will look at whether press-needle ear acupuncture can help lower nausea and vomiting caused by antituberculosis medicines in people with pulmonary tuberculosis. Nausea and vomiting are common side effects of tuberculosis treatment, and they can make people stop taking their medicines\n\nWhen treatment is stopped too early, tuberculosis may not be cured and may become resistant to medicines.\n\nParticipants in this study will have nausea and vomiting related to their tuberculosis treatment. They will be randomly assigned to one of two groups. One group will receive press-needle ear acupuncture. The other group will receive a placebo version that looks similar but does not stimulate acupuncture points\n\nResearchers will check nausea and vomiting scores before treatment, during treatment, and after treatment to see whether press-needle acupuncture works better than placebo and whether it is safe. Press-needle acupuncture may help reduce nausea and vomiting by affecting nerves and lowering certain chemicals that trigger these symptoms, and it has minimal side effects\n\nIf this method is proven helpful and safe, it may give patients a comfortable and low-risk way to manage nausea and vomiting during tuberculosis treatment",[28],"2025-11-27",{"date":320,"type":37},"2025-12-09",{"date":322,"type":37},"2025-11-05",{"date":68,"type":21},{"name":325,"class":44},"Indonesia University",{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":334,"conditions":335,"keywords":336,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":247},"100561069","dosetb-individualised-dosing-by-model-informed-precision-dosing-for-pulmonary-tuberculosis-100561069","NCT06585358","DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis","DoseTB","Inclusion criteria\n\n1. Adult persons ≥18 years with confirmed pulmonary TB (established through Mtb cultures or PCR for Mtb by clinical routine)\n2. Ongoing or planned treatment of TB that includes rifampin\n3. Written informed consent\n\nExclusion criteria\n\n1. TB treatment with rifampin for longer than 8 weeks prior to inclusion\n2. TB treatment with intravenous rifampin (including patients treated at an intensive care unit (ICU) or patients with cerebral TB)\n3. TDM of rifampin has already been performed (\\>24 h before inclusion) by clinical routine\n4. Study participants with extrapulmonary TB without pulmonary TB.",{"count":213,"type":21},"The goal of this observational study is to investigate whether model-informed precision dosing (MIPD), as a clinical support for early individualised dosing in addition to the national TB care program, can optimise the drug exposure of TB drugs during TB treatment.\n\nMain research questions:\n\nIn adult patients with drug-susceptible pulmonary tuberculosis, can current dose recommendations and information received from MIPD help clinicians in a timely manner to optimise the drug exposure of TB drugs in the early treatment phase, i.e., the time from PK sampling to dose adjustment (keep or adjust dose)?\n\nSpecific aims\n\nI. To perform a process evaluation of early MIPD for rifampicin, isoniazid, pyrazinamide and ethambutol during active TB treatment.\n\nII. To study the target attainment of first-line TB drugs with MIPD.\n\nIII. To evaluate model precision of predicted versus detected drug concentrations.\n\nDrug concentrations will be measured in study participants during TB treatment, and drug exposure and the optimal dose will be predicted by MIPD using pharmacokinetic population models.",[28],[337,338],"model-informed precision dosing","individualised dosing","2025-11-18",{"date":341,"type":37},"2025-11-21",{"date":343,"type":37},"2025-11-01",{"date":345,"type":21},"2027-12",{"name":347,"class":44},"Karolinska Institutet",{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":4},"100602908","phase-2-short-course-regimen-with-bedaquiline-moxifloxacin-and-pyrazinamide-for-early-bactericidal-activity-in-drug-susceptible-tuberculosis-100602908","NCT07129629","Short-Course Regimen With Bedaquiline, Moxifloxacin and Pyrazinamide for Early Bactericidal Activity in Drug-Susceptible Tuberculosis","Beams","Inclusion Criteria:\n\n1. Age ≥18 years and ≤60 years\n2. Male or female\n3. Body weight 40-90 kg\n4. Capable of producing adequate sputum, with collection of at least 10ml overnight sputum\n5. Willing to participate in trial treatment and follow-up, with signed informed consent (legal guardian may sign for patients lacking civil capacity)\n6. Positive acid-fast bacilli smear microscopy of respiratory specimens (≥1+ according to WHO criteria) and positive rapid amplification test for Mycobacterium tuberculosis in respiratory specimens\n7. Rifampicin-susceptible based on molecular drug susceptibility testing or conventional drug susceptibility testing\n8. No anti-TB treatment for more than 3 days received within 6 months before the screening period\n9. Subjects whose imaging findings meet the diagnostic criteria for TB, as determined by the investigator\n10. Women of childbearing potential who have not undergone surgical sterilization must agree to use appropriate contraceptive methods\n\nExclusion Criteria:\n\n1. Evidence of concurrent extrapulmonary TB\n2. Subjects who have participated in other clinical studies within 8 weeks before the screening period\n3. Confirmed resistance of mycobacterium tuberculosis isolates to any of the following: Isoniazid, fluoroquinolones, revealed by molecular drug susceptibility testing\n4. Known allergy or intolerance to any study drug\n5. Patients who cannot receive oral therapy\n6. Abnormal liver function (alanine transaminase \\[ALT\\], alkaline phosphatase \\[ALP\\], or total bilirubin \\[TBil\\] exceeding 2 times the upper limit of normal) or known cirrhosis or known alcoholic hepatitis\n7. The hematology indicates white blood cells \\\u003C3.0×10⁹\u002FL, or hemoglobin \\\u003C80 g\u002FL, or platelets \\\u003C80×10⁹\u002FL\n8. The estimated glomerular filtration rate (eGFR) is less than 60 mL\u002Fmin\u002F1.73 m²\n9. The blood electrolyte test indicates a baseline serum potassium level less than 3.5 mmol\u002FL\n10. Subjects who have used drugs known to prolong the QTcF interval for more than 3 days within 30 days before the screening period (including but not limited to amiodarone, bisoprolol, chloroquine, chlorpromazine, cisapride, cyclobenzaprine, clarithromycin, digoxin, dofetilide, domperidone, ertapenem, ibutilide, levomethadone, methadone, pentamidine, quinidine, sotalol, sparfloxacin, thioridazine)\n11. Subjects with clinically significant ECG abnormalities as determined by the investigator, including but not limited to: baseline QTcF \\>450 ms for males or \\>470 ms for females, presence of second- or third-degree atrioventricular block, QRS duration \\>120 ms\n12. Combined heart failure, coronary artery disease, myocardial infarction, ventricular hypertrophy, clinically significant arrhythmia, poorly controlled hypertension-related cardiovascular disease\n13. Patients with known QT prolongation syndrome or a family history thereof\n14. Subjects who have used any drug or substance known to be a strong inhibitor of cytochrome P450 enzymes within 30 days before the screening period (including but not limited to ritonavir, ketoconazole, itraconazole, voriconazole, clarithromycin, fluvoxamine, warfarin, rivaroxaban, and other novel oral anticoagulants)\n15. Subjects with known bleeding disorders or family history of bleeding disorders\n16. Subjects with HIV infection\n17. Subjects with known optic neuritis, history of alcoholism, gout, epilepsy, mental illness, porphyria, myasthenia gravis, or malignant tumors\n18. Patients with type I or type II diabetes, or HbA1c ≥6.5%, or random blood glucose ≥11.1 mmol\u002FL with typical diabetic symptoms\n19. Pregnant or lactating patients","60 Years",{"count":357,"type":21},45,[57],"\\# Brief Summary\n\nThis study aims to evaluate the early bactericidal activity (EBA), safety, and tolerability of 4-month short-course regimens containing bedaquiline, moxifloxacin, and pyrazinamide in patients with drug-susceptible tuberculosis. This is a prospective, randomized, controlled, multicenter study planned to enroll 45 rifampicin-susceptible tuberculosis patients, who will be randomized in a 1:1:1 ratio to the BZMD group (bedaquiline + pyrazinamide + moxifloxacin + delamanid), BZMH group (bedaquiline + pyrazinamide + moxifloxacin + isoniazid), and standard control group. Subjects in the test groups will receive 17 weeks (4 months) of group-specific treatment regimens, while subjects in the control group will receive 26 weeks (6 months) of standard HRZE regimen treatment.\n\nThe primary endpoint is the change from baseline in log₁₀ colony-forming units (CFU) per milliliter of sputum specimen from Day 0 (pre-dose) to Day 14 of treatment (EBA CFU₀-₁₄), used to evaluate the early bactericidal activity of the drugs. Secondary endpoints include EBA CFU and EBA TTP (time to positive culture) at other time intervals, pharmacokinetic characteristics, sustained microbiological clearance rates, relapse rates, and safety indicators. The study will analyze the daily decline in log₁₀ CFU counts and daily increase in TTP using nonlinear mixed-effects models to reflect the bactericidal activity of the study regimens.\n\nThis study will help provide more effective and safer short-course treatment options for Chinese patients with drug-susceptible tuberculosis, thereby improving treatment adherence and treatment success rates, and providing scientific evidence for optimizing short-course treatment regimens for drug-susceptible tuberculosis.",[28,361],"Drug-Susceptible Pulmonary Tuberculosis",[266,269,363,364,365,366],"Pyrazinamide","Early Bactericidal Activity","Drug-Susceptible Tuberculosis","Short-course regimen","2025-08-18",{"date":369,"type":37},"2025-08-19",{"date":371,"type":21},"2025-08-20",{"date":373,"type":21},"2027-12-31",{"name":375,"class":44},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":143,"sex":16,"minAge":383,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":401},"100570997","phase-1-id93gla-se-vaccine-against-tuberculosis-in-older-adults-aged-55-74-100570997","NCT06714513","ID93+GLA-SE Vaccine Against Tuberculosis in Older Adults Aged 55-74","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Explore the Immunogenicity of the Tuberculosis (TB) Vaccine Candidate QTP101 (ID93+GLA-SE) in Older Adults (Aged 55~74 Years)","Inclusion Criteria:\n\n1. Participants who can comply with all scheduled assessment visits during the clinical trial period and who can be continuously monitored by the investigator through the provided contact information\n2. Males or females aged 55 to 74 years at the time of consent\n3. Participants and\u002For legally authorized representatives who are capable of providing written informed consent (signed in person in the presence of a witness)\n4. Participants with either positive or negative QFT test results at the time of screening; QFT testing can be omitted in the following case: If participants have a documented history of a positive QFT test result, evidenced by submitted records or recorded in the EMR\n5. Participants with negative HIV test results at the time of screening\n6. Participants with a record of BCG vaccination or BCG scar directly\n7. Participants who fall within the following range in physical measurements at the time of screening: 19 ≤ Body Mass Index (BMI) ≤ 33 (kg\u002Fm\\^2) BMI and weight results are rounded to the nearest whole number.\n8. Healthy participants or those with well-managed chronic diseases through medical history and clinical examination\n9. Female participants must provide evidence at the screening visit (Visit 1) that they meet one of the following criteria to be considered non-fertile:\n\n   * Non-fertile: Defined as post-menopausal or other infertility conditions. Post-menopausal women: No menstrual periods for at least 12 months after stopping all external hormone treatments and over 55 years old. Documented irreversible surgical infertility such as hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. However, tubal ligation is not permitted.\n   * Fertile: Women of childbearing potential who have not undergone sterilization must agree to use appropriate contraception during the investigational product administration period and for 6 months after the end of the investigational product administration. They must undergo a serum pregnancy test (β-hCG test) at the screening visit (Visit 1) and urine pregnancy tests (Urine-hCG test) at subsequent visits, with negative HCG results required.\n10. Male participants can be enrolled under the following conditions: Men who have not undergone vasectomy must agree to use barrier contraception (e.g., condoms) and agree that both they and their partner will use appropriate contraception during the investigational product administration period and for 6 months after the end of the investigational product administration.\n11. Participants who understand the clinical trial procedures, voluntarily decide to participate and sign the informed consent form\n12. Participants recommended for tuberculosis prevention treatment who have been adequately informed about and understand latent tuberculosis chemoprophylaxis, and voluntarily agree to participate in the clinical trial while expressing non-consent to the chemoprophylaxis\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria must be excluded from enrollment.\n\n1. Participants who are suspected of having tuberculosis, have a history of tuberculosis, are currently undergoing treatment for tuberculosis, are being treated for latent tuberculosis infection, or have a history of medication treatment for latent tuberculosis infection at the time of the Screening (Visit 1) or the first administration (Visit 2)\n2. Participants who have received other investigational products or used unapproved drugs within 6 months prior to participating in the clinical trial or who plan to use them during the trial period\n3. Participants who have previously received an investigational tuberculosis vaccine\n4. Participants who test positive for HIV at the screening visit\n5. Participants who test positive for HCV or who test positive for HBsAg and negative for HBsAb in HBV tests at the screening visit\n6. Participants who are exposed to or will be exposed to investigational or non-investigational products during the clinical trial period or who participate in another clinical trial simultaneously\n7. Participants who have received immunoglobulins and\u002For any blood products within 90 days before the first administration of the investigational product or plan to receive them during the clinical trial period\n8. Pregnant or breastfeeding female\n9. Participants with the following medical or psychiatric conditions that make it impossible to conduct the clinical trial as judged by the principal investigator:\n\n   * Participants with acute fever (an arbitrary body temperature of 38°C or higher at the time of randomization or within 24 hours before randomization), acute respiratory disease, or active infection.\n   * Participants with malignancies or a history of malignancies within the past 5 years.\n   * Participants with respiratory diseases: who have received treatment for acute exacerbation or moderate exacerbation of a respiratory condition within 2 years prior to the first administration of the investigational product. (Participants with a history of high-risk pulmonary diseases, such as silicosis, may be excluded at the investigator's discretion, regardless of the treatment period or even if the history is beyond the past 2 years. However, participants with controlled asthma or COPD stage 0 (at-risk) may participate with judgment of the principal investigator.)\n   * Participants with serious cardiovascular diseases: congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, etc.\n   * Participants with neurological diseases: epilepsy, seizures within 3 years before the first administration of the investigational products, migraines, strokes, encephalopathy, Guillain-Barre syndrome, etc.\n   * Participants with a history of COVID-19 infection within 90 days before the screening visit (confirmed positive by NAAT or rapid antigen test) or who have not recovered from COVID-19-related symptoms after being diagnosed with COVID-19 more than 90 days before the screening visit.\n   * Participants with autoimmune hypothyroidism, autoimmune diseases, immunodeficiency diseases.\n   * Participants with other clinically significant medical histories related to the hepatobiliary system, kidneys, endocrine system, urinary system, musculoskeletal system, etc., as judged by the principal investigator.\n   * Participants with a history of hereditary or idiopathic angioedema.\n   * Participants with a history of organ or bone marrow transplantation.\n   * Participants with a history of platelet-related or bleeding disorders, a history of significant bleeding or bruising following intramuscular injection or venipuncture, or who are receiving anticoagulants.\n10. Participants who have received radiation therapy within 12 months before the first administration of the investigational product. However, those who have received radiation therapy to the lungs are excluded regardless of the time frame.\n11. Participants who have surgery planned during the clinical trial period\n12. Participants with a history of severe allergic reactions or anaphylaxis to vaccines or other allergens\n13. Participants with clinically significant abnormal findings in laboratory tests, ECG, or chest X-ray at the screening visit as judged by the principal investigator to be unsuitable for participation. Participants with fibrotic nodular lesions on chest X-ray (indicative of spontaneously healed tuberculosis lesions without a history of tuberculosis treatment)\n14. Participants who have chronically received immunosuppressants or other immunomodulatory drugs within 6 months before the first administration of the investigational product\n\n    * High-dose corticosteroids (continuous use of doses exceeding 15 mg\u002Fday of prednisolone for more than 14 days)\n    * However, topical steroids, nasal sprays, inhalers, and eye drops are allowed regardless of the dose\n15. Participants who are deemed unsuitable for this clinical trial by the principal investigator for any other reasons\n16. Participants with cognitive impairment.\n17. Household contacts and close contacts who have been in an indoor environment with an active tuberculosis patient\n\n    * Household Contact: Family members and cohabitants who have been living in the same space or regularly interacting for at least 3 months.\n    * Close Contact: Individuals other than household contacts who have had direct contact in an enclosed indoor environment (e.g., classroom, office) for an extended period, defined as continuous or daily contact for at least 8 hours per day, or cumulative contact of 40 hours or more.","55 Years","74 Years",{"count":386,"type":21},144,[388],"PHASE1","The purpose of this study is to evaluate the safety and explore the immunogenicity of ID93+GLA-SE compared to placebo following three intramuscular (IM) injections on Days 0, 28 and 56 in the Bacillus Calmette-Guérin (BCG)-vaccinated older adults aged 55 to 74 with negative or positive result on the QuantiFERON-TB (QFT) test. Eligible participants will be randomly assigned based on age group and the QFT test results to receive either QTP101 (Dose 1 and Dose 2) or placebo.\n\nSafety and immunogenicity will be monitored from the first dose until 12 months after the final dose of the investigational product. Blood samples for immunogenicity analysis will be collected at five-time points: before the first dose (Day 0), 4 weeks after the first dose (Day 28), 4 weeks after the second dose (Day 56), 4 weeks after the third dose (Day 84), and 48 weeks after the third dose (Day 392). Once the safety and immunogenicity follow-up is completed 48 weeks after the third dose (Day 392) for the last enrolled participant, a final report will be compiled based on the collected data.",[28],"2025-06-12",{"date":393,"type":37},"2025-06-17",{"date":395,"type":37},"2025-05-09",{"date":397,"type":21},"2026-12",{"name":399,"class":400},"Quratis Inc.","INDUSTRY",4,{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":421,"locationsCount":247},"100552753","phase-2-characterization-of-tuberculosis-associated-lung-fibrosis-and-respiratory-impairment-and-prevention-using-doxycycline-100552753","NCT06477185","Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline","Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline in A Double Blind Randomized Controlled Trial","TALF-TB","Inclusion Criteria:\n\n* Age of 18 - 65 years\n* Index PTB episode (sputum smear positive or GeneXpert positive with rifampicin susceptibility)\n* Baseline CXR showing infiltrates in at least 2 lung zones (≥30% lung involvement) meeting criteria for moderate\u002Fadvanced PTB\n* HIV uninfected\n* Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Able to give written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Baseline serum creatinine or liver enzymes \\>2 times above upper limit of normal\n* Taking corticosteroids for ≥14 days or anti-TBs \\>7days\n* Prospects already enrolled in another clinical trial\n* Diabetic patients (most diabetics are on metformin or have history of metformin use. Metformin is postulated to have an anti-fibrosis role)\n* Patients with malignancy or on anticancer medication\n* Situation where a participant is taking a drug\u002Fmedication known to interact with the trial drug.\n* Known allergies to doxycycline or other tetracyclines\n* Known autoimmune disease\n* Any factor felt to significantly increase risk of adverse event",{"count":411,"type":21},200,[57],"The goal of this clinical trial is to assess the efficacy(effectiveness) of doxycycline, a potent inhibitor of matrix metalloproteinase (lung collagenase) activity in prevention of Tuberculosis associated lung fibrosis and associated lung function decline among patients with drug sensitive advanced TB. The main question\\[s\\] it aims to answer are:\n\n* Does doxycycline have a significant anti-fibrosis role when given as adjuvant therapy to TB patients with advanced pulmonary TB in a double blind randomized placebo controlled trial?\n* How does long term respiratory function defer between patients who received adjuvant doxycycline aimed at prevention of TB associated lung fibrosis and those who received a placebo in a double blind randomized controlled trial?\n\nParticipants will be subjected to the following:\n\n* Experimental arm: Doxycycline 100 mg once daily for 12 weeks administered concurrently with standard of care anti-TBs.\n* Comparator arm: Placebo once daily for 12 weeks administered concurrently with standard of care anti-TBs.",[28],"2025-04-14",{"date":417,"type":37},"2025-04-17",{"date":419,"type":37},"2024-12-04",{"date":345,"type":21},{"name":422,"class":44},"Makerere University",{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":143,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":431,"targetDuration":433,"studyType":170,"phases":4,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":449,"locationsCount":159},"100570388","a-systemic-screening-for-tb-disease-in-high-risk-groups-in-barcelona-100570388","NCT06706596","A Systemic Screening for TB Disease in High-risk Groups in Barcelona","Implementing a Systemic Screening for TB Disease in High-risk Groups in Barcelona Area","SYS-TB-S","Inclusion Criteria:\n\n-Belonging to a population at high risk for tuberculosis (TB)\n\nExclusion Criteria:\n\n-Not belonging to a population at high risk for tuberculosis (TB)",{"count":432,"type":21},3000,"1 Year","The purpose of this screening study is to identify and screen vulnerable population in Barcelona for active pulmonary tuberculosis",[103,28],[103,437,438,439,440,441,442],"Tuberculosis infection","Tuberculosis screening","Vulnerable populations","Refugees","Migrants","Pulmonary tuberculosis","2024-11-26",{"date":445,"type":37},"2024-11-29",{"date":447,"type":37},"2022-07-22",{"date":244,"type":21},{"name":450,"class":44},"Fundació Institut Germans Trias i Pujol",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":464,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":474,"locationsCount":159},"100373810","phase-2-atorvastatin-to-reduce-inflammation-after-tuberculosis-treatment-completion-100373810","NCT04147286","Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion","Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion in HIV-infected and HIV-uninfected Adults Measured by FDG-PET\u002FCT","StatinTB","Inclusion Criteria\n\n1. Has completed the written informed consent process prior to undergoing any pre-screening or screening evaluations and willing to undergo HIV testing\n2. Age 18 to 65 years with body weight from 50 kg to 90 kg\n3. Clinical response to TB treatment and sputum culture negative at week 16\n4. Completed a 24-week course of standard TB treatment (4RHZE\u002F2RH)\n5. Defined as \"cured\" by the TB Control Program of South Africa\n\n   Laboratory parameters within 30 days before enrolment:\n6. For HIV-infected participants: receiving antiretroviral therapy for at least 12 weeks and suppressed HIV viral load within 30 days prior to enrolment\n7. For HIV-infected participants: CD4 counts above 350 cells\u002FµL within 30 days prior to enrolment\n8. AST and ALT \\\u003C3x upper limit of normal (ULN)\n9. Creatinine \\\u003C2x ULN\n10. Hemoglobin \\>7.0 g\u002FdL\n11. Platelet count \\>50 x109 cells\u002FL\n12. Creatinine kinase \\\u003C2x ULN\n13. Able and willing to return to follow-up\n14. Willing to have samples, including DNA, stored\n15. Willing to consistently practice a highly reliable method of pregnancy prevention\n\nExclusion criteria\n\n1. Acute illness\n2. Fever (temperature \\>38.0 degrees centigrade)\n3. Participant receiving any type of lipid lowering agent at the time of screening, within three months prior to screening or likely to require any lipid lowering agent in the near future.\n4. Known allergy or contraindications to the investigational drug or any other statins\n5. Evidence of drug-resistant TB\n6. Extrapulmonary TB, including pleural TB and\u002For large pleural effusion\n7. Pregnant or desiring\u002Ftrying to become pregnant in the next 6 months\n8. Unable to take oral medications\n9. Diabetes as defined by point of care HbA1c≥6.5, random glucose≥200mg\u002FdL (or 11.1mmol\u002FL), fasting plasma glucose≥126mg\u002FdL (or 7.0mmol\u002FL), or the presence of any anti-diabetic agent (including traditional medicines) as a concomitant medicine\n10. Disease complications or concomitant illnesses that may compromise safety or interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)\n11. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks\n12. Use of any investigational drug in the previous 3 months\n13. Alcohol and substance abuse which might interfere with medication adherence during the trial\n14. Any person for whom the physician feels this study is not appropriate",{"count":460,"type":21},220,[57,100],"This is a proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of 40 mg atorvastatin to reduce persistent lung inflammation after successful TB treatment completion in HIV-infected and HIV-uninfected adults measured by PET\u002FCT.",[28],[61,465,466,467],"HIV","COPD","inflammation","2024-08-22",{"date":470,"type":37},"2024-08-23",{"date":472,"type":37},"2020-07-14",{"date":132,"type":21},{"name":475,"class":44},"University of Cape Town",{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":484,"briefSummary":485,"conditions":486,"keywords":487,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":4},"100556510","phase-3-a-short-regimen-for-rifampicin-resistant-isoniazid-susceptible-tb-100556510","NCT06526039","A Short Regimen for Rifampicin-resistant Isoniazid-susceptible TB","A Short Regimen for Patients With Rifampicin-resistant Isoniazid-susceptible Tuberculosis","Inclusion Criteria:\n\nA patient will be eligible for entry to the study if he\u002Fshe:\n\n* Is willing and able to give informed consent to be enrolled in the trial treatment and follow-up (signed or witnessed consent if the patient is illiterate)\n* Is aged 18 years or older\n* Has bacteriologically-confirmed pulmonary tuberculosis by Xpert MTB\u002FRIF, other nucleic acid amplification test, or culture\n* With initial laboratory result of resistance to rifampicin by Xpert MTB\u002FRIF or Xpert MTB\u002FRIF ultra, or other DST (line probe assay, culture); and with initial laboratory result that is susceptible to isoniazid by Xpert MTB\u002FRIF or other DST. If rifampicin resistance is detected by Xpert MTB\u002FRIF or Xpert MTB\u002FRIF ultra in specimens with very low bacillary, rifampicin resistance has been confirmed by a repeat molecular test.\n* With initial laboratory result of being susceptible to rifampicin by Xpert MTB\u002FRIF or other DST (Xpert MTB\u002FRIF ultra, line probe assay, culture) but are not able to tolerate rifampicin for whom rifabutin is intolerable or clinically not indicated; and with initial laboratory result that is susceptible to isoniazid by Xpert MTB\u002FRIF or other DST\n* With initial laboratory result of being susceptible to rifampicin by Xpert MTB\u002FRIF or other DST (Xpert MTB\u002FRIF ultra, line probe assay, culture) but rifamycin-sparing regimens are preferred due to drug-drug interaction, such as organ transplant recipients; and with initial laboratory result that is susceptible to isoniazid by Xpert MTB\u002FRIF or other DST.\n* With initial laboratory result that is susceptible to fluoroquinolone by Xpert MTB\u002FXDR or other DST.\n* If HIV test positive, is willing to be treated with ART in accordance with the national policies.\n* Agrees to use effective barrier contraception or have an intrauterine contraceptive device during treatment phase if a pre-menopausal woman\n* Has an identifiable address and expects to remain in the area for the duration of the study\n* Is willing to adhere to the follow-up schedule and to study procedures\n\nExclusion Criteria:\n\nA patient will not be eligible for entry to the study if he\u002Fshe:\n\n* Is infected with a strain of M. Tuberculosis resistant to isoniazid by Xpert MTB\u002FXDR or other tests\n* Is infected with a strain of M. Tuberculosis resistant to fluoroquinolone by Xpert MTB\u002FXDR or other tests\n* Is infected with a strain of M. Tuberculosis resistant to amikacin by Xpert MTB\u002FXDR or other tests and have no result of susceptibility of isoniazid by conventional drug susceptibility testing\n* Has tuberculous meningitis or bone and joint tuberculosis\n* Is critically ill, and in the judgment of the investigator, unlikely to survive more than 4 months.\n* Is known to be pregnant or breast-feeding\n* Is unable to attend or comply with treatment or follow-up schedule\n* Is unable to take oral medication\n* Has AST or ALT \\>5 times the upper limit of normal\n* Has AST or ALT \\> 3 times the upper limit of normal ,and either with symptoms of hepatitis or bilirubin \\> 1.5 times the upper limit of normal\n* Has any condition (social or medical) which in the opinion of the investigator would make study participation unsafe.\n* Is taking any medications contraindicated with the medicines in either the trial or control regimen\n* Has a known allergy to any fluoroquinolone antibiotic\n* Is currently taking part in another trial of a medicinal product\n* Has a QTcF interval of ≥450msec at screening",{"count":55,"type":21},[100],"To assess outcome of treatment and safety among patients with rifampicin-resistant isoniazid-susceptible pulmonary tuberculosis treated with a novel regimen consisting of isoniazid, bedaquiline, and moxifloxacin throughout for 6 months, supplemented by pyrazinamide for the initial 2 months.",[28],[488,489,111,61,490],"bedaquiline","isoniazid","rifampicin resistance","2024-07-24",{"date":493,"type":37},"2024-07-29",{"date":495,"type":21},"2024-07",{"date":497,"type":21},"2029-12",{"name":499,"class":44},"Taipei Medical University WanFang Hospital",{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":143,"sex":16,"minAge":52,"maxAge":508,"enrollmentInfo":509,"targetDuration":4,"studyType":170,"phases":4,"briefSummary":511,"conditions":512,"keywords":516,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":159},"100497387","prevalence-of-latent-tuberculosis-infection-in-health-care-workers-and-students-100497387","NCT05756582","Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students","Cross-sectional Study on Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students. A GENERATOR Infrastructure.","CROSSWORD","Inclusion Criteria:\n\n* all health-care workers of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome,\n* all students of all three-year and single-cycle degree courses, master's degree courses, graduate schools of the faculty of Medicine and Surgery of the Catholic University of Sacred Heart in Rome, trained at the Fondazione Policlinico Universitario A. Gemelli IRCCS,\n* written informed consent.\n\nExclusion Criteria:\n\n* denied informed consent.","72 Years",{"count":510,"type":21},2040,"This study is a cross-sectional study that examines the prevalence of Latent Tuberculosis Infection \\[LTBI\\], defined as individuals infected with Mycobacterium tuberculosis with no clinical evidence of disease, and the possible risk factors of LTBI in a large cohort of health care workers (HCWs) and students.",[103,28,513,514,515],"Tuberculosis Infection","Latent Tuberculosis","Health Care Associated Infection",[517,518,519,520],"latent tuberculosis infection","health-care workers","students","survey","2024-02-12",{"date":523,"type":37},"2024-02-13",{"date":525,"type":37},"2021-11-17",{"date":527,"type":21},"2026-12-15",{"name":529,"class":44},"Eleonora Nucera",{"id":531,"slug":532,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":355,"enrollmentInfo":538,"targetDuration":4,"studyType":22,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":546,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":279},"100470072","phase-2-optimizingo-rifapentine-basedri-regimen-and-shorteningen-the-treatment-of-drug-sensitive-tuberculosist-100470072","NCT05401071","Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)","Efficacy and Safety of Short-course Treatment for Drug-sensitive Tuberculosis in China","ORIENT","Inclusion Criteria:\n\n* Age between 18 to 60 years;\n* Weight between 40 to 80 kg;\n* Individuals with smear-positive pulmonary tuberculosis and sensitive to rifampicin ;\n* Willing to provide signed informed consent, or parental consent and participant assent.\n* If you are a non-menopausal woman, agree to use or have used effective contraception during treatment.\n\nExclusion Criteria:\n\n* Combined extrapulmonary tuberculosis;\n* Patients with extensive lesion (extent of disease greater than 50% or cavity size greater than 4cm) ;\n* Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones;\n* Alcohol abuse#drinking more than 64g of ethanol a day for male, 42g for female#;\n* Hemoglobin is less than 70g\u002FL or platelet is less than 100\\*10\\^9\u002FL;\n* Patients with impaired liver function (hepatic encephalopathy, ascites; total bilirubin is higher than the upper limit of normal; Alanine aminotransferase or aspartate aminotransferase is higher than the upper limit of normal);\n* Blood creatinine is more than 1.5 times the upper limit of normal;\n* More than five days of systemic treatment with any one or more of the following drugs within 6 months preceding initiation of study drugs: isoniazid, rifampin, rifabutin, rifapentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin, capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline;\n* Known history of prolonged QT syndrome;\n* Current or planned use within six months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than efavirenz; quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine;\n* Known allergy or intolerance to any of the study medications;\n* AIDS patients;\n* Pregnant or breast-feeding.",{"count":539,"type":21},2442,[57,100],"Tuberculosis (TB) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens.\n\nThis is a multicenter prospective, non-inferiority randomized controlled study. The purpose of our study is a) to evaluate the tolerability, efficacy and pharmacokinetics\u002Fpharmacodynamics (PK\u002FPD) of the high-dose rifapentine, b) to evaluate whether the high-dose rifapentine-containing regimen has the potential to treat the rifampicin-sensitive pulmonary tuberculosis and shorten the course of treatment to 17 weeks. This study is of great significance for shortening the course of treatment, reducing the adverse reactions and economic burden of patients' treatment in rifampicin-sensitive tuberculosis patient.",[28],[110,544,545],"shorter treatment","pulmonary tuberculosis","2023-12-08",{"date":548,"type":37},"2023-12-11",{"date":550,"type":37},"2023-01-13",{"date":552,"type":21},"2027-11-01",{"name":554,"class":44},"Huashan Hospital",{"id":556,"slug":557,"hasResults":11,"nctId":558,"briefTitle":559,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":562,"enrollmentInfo":563,"targetDuration":565,"studyType":170,"phases":4,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":247},"100480671","tuberculosis-cohort-avicenne-hospital-100480671","NCT05539014","Tuberculosis Cohort Avicenne Hospital","COTB-AVC","Inclusion Criteria:\n\n* Tuberculosis out- or in-patient newly treated in one of the inclusion centers for pulmonary or extra-pulmonary\n* Tu confirmed bacteriologically (direct examination, Gen-eXpert MTB\u002FRIF and\u002For positive culture), suggestive histology (epithelioid gigantocellular granuloma with or without caseous necrosis), or strong clinical suspicion of tuberculosis, even if not yet biologically confirmed but with\n* A decision to introduce treatment.\n\nExclusion Criteria:\n\n* opposition to participate in the study, anti-tuberculosis treatment for more than 7 days at the inclusion visit and participation in another research protocol.","80 Years",{"count":564,"type":21},250,"12 Months","Tuberculosis represents the second highest death rate from an infectious disease in the world, just after COVID-19. The most affected department of France is Seine-Saint-Denis. Since 2005, this department with difficult socio-economic conditions has the highest incidence rate in metropolitan France, higher than that of Paris. In 2012, the reporting rate was 10 times higher among people born abroad compared to those born in France, with the highest rates found among people born in sub-Saharan Africa and Asia.\n\nIt is proposed to constitute for the first time in France a cohort of patients with tuberculosis disease to better understand the characteristics of patients with unfavorable treatment outcomes and ultimately, to propose solutions to obtain better control of tuberculosis. This study would recruit all patients with tuberculosis disease for at least 4 years associated with 1 year of follow-up for a total duration of the study of at least 5 years.",[28],"2023-11-15",{"date":570,"type":37},"2023-11-18",{"date":572,"type":37},"2023-01-18",{"date":574,"type":21},"2027-12-15",{"name":576,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":578,"slug":579,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":584,"enrollmentInfo":585,"targetDuration":4,"studyType":22,"phases":587,"briefSummary":588,"conditions":589,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":4},"100474165","phase-3-sitafloxacin-containing-regimens-for-shortening-tuberculosis-treatment-100474165","NCT05454345","Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment","A Randomized Controlled Non-Inferiority Study for Shortening Tuberculosis Treatment With Sitafloxacin-Containing Regimens","Inclusion Criteria:\n\n1. Age 18 years to 70.\n2. At least one sputum specimen is positive for acid-fast bacilli or positive results of sputum culture on smear microscopy(species identification as M. tuberculosis) or at least one sputum specimen positive for M. tuberculosis by Xpert MTB\u002FRIF testing.\n3. Phenotypic drug susceptibility testing indicates the patient's isolate is susceptible to rifampin, isoniazid, pyrazinamide, ethambutol, rifapentine, moxifloxacin, and Sitafloxacin.\n4. Patients have written informed consent.\n\nExclusion Criteria:\n\n1. Extra-pulmonary or Disseminated TB.\n2. HIV-positive individuals, steroid-dependent and those on steroid treatment.\n3. Autoimmune diseases, severe hepatic or renal dysfunction, psychosis, hematological malignancies, cancer, diabetes individuals.\n4. Known allergy to one or more of the study drugs.\n5. Women who are currently pregnant or breast-feeding.\n6. Patients who received any investigational drug in the past three months.\n7. The patients refused treatment with medications\n8. Mycobacterium tuberculosis\u002Fnontuberculous mycobacterium co-infection.\n9. In the investigator's judgment, other medical conditions that are not in the individual's best interest to participate.","70 Years",{"count":586,"type":21},620,[100],"This study is a clinical trial conducted to determine whether the sitafloxacin-containing three-month regimens are as effective as the standard six-month regimen and the four-month rifapentine and moxifloxacin regimen (substitution of rifapentine for rifampin and moxifloxacin for ethambutol) for treatment of pulmonary tuberculosis. The standard six-month regimen is two months of isoniazid, rifampin, ethambutol, and pyrazinamide, followed by four months of isoniazid and rifampin. The four-month regimen consists of two months of isoniazid, rifapentine, moxifloxacin, and pyrazinamide, followed by two months of isoniazid rifapentine and moxifloxacin. The new three-month tuberculosis treatment regimens are six weeks of isoniazid, rifapentine, Sitafloxacin, and pyrazinamide, followed by seven weeks of isoniazid, rifapentine, and Sitafloxacin, or 13 weeks of isoniazid, rifapentine, Sitafloxacin, and pyrazinamide. The primary research question is to evaluate the efficacy and safety of the 3 month Sitafloxacin-containing regimen, and to determine if it can shorten the treatment of drug-susceptible pulmonary tuberculosis while achieving non-inferiority in treatment success with the current 6 month and 4 month treatment regimens. Safety, side effects of Sitafloxacin for participants in the clinical trial are also assessed. Rates of cure, treatment success, recurrence, and cure (cure without recurrence) are determined for subgroup analysis in the standard six-month regimen group, the four-month regimen group, and two three-month regimen groups.",[28],"2022-07-07",{"date":592,"type":37},"2022-07-12",{"date":594,"type":21},"2022-10-01",{"date":68,"type":21},{"name":597,"class":44},"First Affiliated Hospital of Zhejiang University",{"id":599,"slug":600,"hasResults":11,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":11,"sex":16,"minAge":606,"maxAge":607,"enrollmentInfo":608,"targetDuration":4,"studyType":22,"phases":610,"briefSummary":611,"conditions":612,"keywords":613,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":159},"100399740","phase-3-treatment-shortening-of-drug-sensitive-pulmonary-tuberculosis-using-high-dose-rifampicin-hi-dori-3-100399740","NCT04485156","Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)","Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin to 3 Months After Culture Conversion (Hi-DoRi-3): A Phase 3, Multicenter, Randomized, Open-label, Clinical Trial","Hi-DoRi-3","Inclusion Criteria:\n\n* Documented positivity by sputum Xpert MTB\u002FRIF assay\n* Administration of current tuberculosis therapy (if any) for no more than 7 days (≤7) at the time of enrolment.\n\nExclusion Criteria:\n\n* Negative on Xpert MTB\u002FRIF assay\n* Resistance to rifampicin as detected by an Xpert MTB\u002FRIF assay\n* Known resistance to isoniazid, rifampicin, or pyrazinamide\n* HIV positive\n* Cancer patient on anti-cancer chemotherapy\n* Uncontrolled DM\n* Chronic hepatitis, liver cirrhosis\n* Any contraindications of drugs to be used","19 Years","85 Years",{"count":609,"type":21},926,[100],"The purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after Culture Conversion) for the treatment of drug-sensitive pulmonary tuberculosis.",[28],[103,614,615,616],"Rifampicin","Treatment","Shortening","2020-07-21",{"date":619,"type":37},"2020-07-24",{"date":621,"type":21},"2020-09",{"date":397,"type":21},{"name":624,"class":44},"Seoul National University Hospital"]