[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tb---tuberculosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tb---tuberculosis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,75,102,131,153,175],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100643820","phase-4-comparative-trial-between-ainuovirineanvlamivudine3tctenofovirtdf-and-efavirenzefvlamivudinetenofovir-regimens-100643820",false,"NCT07631897","Comparative Trial Between Ainuovirine(ANV)\u002FLamivudine(3TC)\u002FTenofovir(TDF) and Efavirenz(EFV)\u002FLamivudine\u002FTenofovir Regimens","Comparative Study on Antiviral Efficacy and Safety of Ainuovirine\u002FLamivudine\u002FTenofovir Versus Efavirenz\u002FLamivudine\u002FTenofovir Regimen in HIV Patients With Active Tuberculosis Infection: A Two-stage Prospective Multicenter Clinical Study","ALT VS TLE","Inclusion Criteria:\n\n* Aged between 18 and 65 years;\n* Body weight ≥ 40 kg with BMI ranging from 18.5 to 30 kg\u002Fm²;\n* Treatment-naïve patients with HIV-1 infection who are planned to initiate antiretroviral therapy;\n* Diagnosed with active Mycobacterium tuberculosis infection and receiving anti-tuberculosis regimen containing rifampicin and isoniazid;\n* CD4⁺ T cell count ≥ 25 cells\u002FμL;\n* HIV RNA viral load \\\u003C 500,000 copies\u002FmL;\n* Subjects who can fully understand the nature, methods and potential adverse reactions of this trial, comply with the requirements stated in the informed consent form, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects with allergic constitution or a history of allergy to the study drugs and excipients;\n* Those with a history of drug addiction, substance abuse, or chronic alcoholism;\n* Pregnant or lactating women; women of childbearing potential who cannot adopt effective contraceptive measures (e.g., contraceptive diaphragm, condom, intrauterine device, partner vasectomy), or whose sexual partners fail to implement effective contraception;\n* Subjects who have used drugs with moderate to high drug drug interaction potential with the study drugs (excluding anti tuberculosis drugs) within 2 weeks prior to formal enrollment and ART initiation (only applicable to the pre trial phase);\n* Those who are unable to receive oral anti tuberculosis treatment during antiretroviral therapy;\n* Subjects with baseline drug resistance test results showing resistance to NNRTIs, 3TC or TDF;\n* Those with resistance to one or more anti tuberculosis drugs;\n* Subjects diagnosed or tentatively diagnosed with tuberculous meningitis;\n* Patients complicated with other severe opportunistic infections besides Mycobacterium tuberculosis infection;\n* Abnormal liver function: alanine transaminase (ALT)\u002Faspartate transaminase (AST) \\> 3×ULN with clinical symptoms, or \\> 5×ULN without symptoms; total bilirubin (TBil) \\> 2×ULN;\n* Impaired renal function: estimated glomerular filtration rate (eGFR) calculated by the CKD EPI formula \\\u003C 60 mL\u002Fmin\u002F1.73 m²;\n* Subjects complicated with tumors, severe neurological or psychiatric diseases, metabolic disorders, gastrointestinal diseases or other comorbidities that, in the investigator's judgment, may affect their participation and completion of the study;\n* Any other conditions deemed inappropriate for enrollment by the investigator.","ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","This is a prospective, multicenter, open-label, parallel-controlled study. The primary objective is to prospectively explore and compare the virological efficacy of Ainuovirine\u002FLamivudine\u002FTenofovir and Efavirenz\u002FLamivudine\u002FTenofovir regimens combined with rifampicin and isoniazid-based anti-tuberculosis therapy in HIV-infected patients with active tuberculosis.\n\nParticipants are divided into two groups to compare the virological suppression rate and immunological efficacy between the two antiretroviral regimens. All subjects will receive continuous antiretroviral medication and anti-tuberculosis drugs under medical supervision throughout the study.",[28,29,30],"HIV","Art Therapy","TB - Tuberculosis","NOT_YET_RECRUITING","2026-06-01",{"date":34,"type":35},"2026-06-08","ACTUAL",{"date":37,"type":22},"2026-06",{"date":39,"type":22},"2028-12",{"name":41,"class":42},"Shanghai Public Health Clinical Center","OTHER_GOV",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100416278","pre--and-post-treatment-lung-microbiota-metabolome-and-immune-signatures-at-the-site-of-disease-in-patients-with-active-pulmonary-tuberculosis-100416278","NCT04700579","Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis","TB-LUNG","Inclusion Criteria:\n\n* 18-60 years old.\n* Agree to undergo CXR and\u002For CT scan.\n* Has unilateral TB disease defined as one lung with extensive evidence of TB disease (non-applicable to healthy controls; sick controls will require an alternative diagnosis).\n* No evidence of prior TB treatment and\u002For CXR\u002FCT does not have obvious evidence of prior TB.\n* Willing to undergo a research bronchoscopy at baseline, 6 months and 18 months and likely to remain in the area for the study period.\n* If HIV-positive, must be stable on antiretroviral therapy (ART) for ≥1 year.\n* Able and willing to return for follow-up visits, with no plans to move in the near future.\n* Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment.\n\nExclusion Criteria:\n\n* Less than 18 years or older than 60 years of age.\n* Has already initiated TB treatment.\n* Rifampicin resistant.\n* Has a previous history of TB.\n* Bilateral TB disease defined as both lungs with extensive TB disease\n* Has received probiotics, antibiotics or inhaled steroids within three months prior to enrolment (not applicable to sick controls)\n* Has diabetes mellitus, which affects TB disease, treatment response, and the microbiome\n* Has a contraindication for bronchoscopy (e.g., FEV1 \\\u003C70%), as determined by bronchoscopists according to best practice guidelines\n* Has a daily alcohol intake of more than 6 beers or 4 mixed drinks\n* Is pregnant (a commercial human chorionic gonadotropin determination assay will be performed in accordance with manufacturer's guidance on urine) or pregnancy planned for follow-up period\n* Recent hospitalization for any reason",true,"60 Years",{"count":53,"type":22},150,"18 Months","OBSERVATIONAL","The diverse microbial communities in different parts of the human body (microbiome) are important for health but understudied in pulmonary tuberculosis (TB), which is the single biggest infectious cause of death in the world. The investigators will study the site-of-disease microbiome (in the lung bronchoalveolar space) in TB cases to investigate how, before TB treatment, metabolic compounds made by microbes affect host biomarkers important for TB control. The investigators will ask this question again at the end-of-treatment and one year later. Specifically, the investigators will sample the lung at the active TB hotspot identified by imaging and compare this to a non-involved lung segment usually in the opposite lung. The investigators will compare the lung microbiome to other sites in the body (i.e. oral cavity, nasopharynx, supraglottis, and gut). A small amount of blood (\\~15 ml) will be collected to assess peripheral immunological correlates of the host microbiome. Protected specimen brushings of the lung will be used to explore transcriptomic signatures and how these relate to the lung microbiome. The investigators will also apply these questions to the same number of controls (healthy patients and patients with an alternative diagnoses). This will lay the foundation for clinical trials to evaluate if specific bacteria have diagnostic (e.g., PCR) or therapeutic potential (e.g., antibiotics, prebiotics, probiotics, vaccines) where targeting the microbiome could improve clinical outcomes.",[30,58],"HIV\u002FAIDS",[60,61,62],"Microbiome","Short Chain Fatty Acids","Immunological Biomarkers","RECRUITING","2026-04-29",{"date":66,"type":35},"2026-05-06",{"date":68,"type":35},"2021-03-04",{"date":70,"type":22},"2027-12-31",{"name":72,"class":73},"University of Stellenbosch","OTHER",3,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":50,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100632729","start4all-screen-tb-protocol-100632729","NCT07517471","Start4All SCREEN-TB PROTOCOL","Start4All - Start Taking Action for TB Diagnosis SCREEN-TB","SCREEN-TB","Inclusion Criteria:\n\n1. Age\n\n   * Adults aged 15 years and above or\n   * Adolescents aged 10-14 years\n2. Facility setting\n\n   o Participating healthcare facilities (e.g., primary health centres, district hospitals), including both rural and urban facilities.\n3. Screening eligibility\n\n   o All individuals presenting to the facility, regardless of symptoms or ability to produce sputum, will be eligible for inclusion.\n4. Consent\n\n   * Written informed consent (and assent for adolescents (10-14 years) and adults (≥15 - 17 years) if included) must be obtained according to local ethics and regulatory requirements.\n\nExclusion Criteria:\n\n1. Age\n\n   o Below 10 years at enrolment\n2. Screening eligibility\n\n   o Do not screen positive on any tools.\n3. Consent and follow-up\n\n   o Unable or unwilling to provide written informed consent (and assent where applicable) or unwilling to agree to follow-up visits.\n4. Current TB treatment\n\n   o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment.\n5. Recent TB preventive therapy\n\n   o Receipt of TB preventive therapy within the last 6 months prior to enrolment.\n6. Clinical danger signs\n\n   o Presence of severe illness at screening, including but not limited to: Respiratory rate \\>30\u002Fmin Fever \\>39°C Pulse rate \\>120\u002Fmin Inability to walk unaided\n7. Duplicate enrolment o Previous enrolment in SCREEN-TB.","10 Years",{"count":85,"type":22},37000,[87],"NA","Tuberculosis (TB) remains the leading cause of death from a single infectious agent globally, with millions of people still undiagnosed or diagnosed late. Conventional case-finding strategies rely heavily on symptom screening using the WHO Four-Symptom Screen ((W4SS; comprising any one of current cough, fever, night sweats, or weight loss) and sputum testing, but these approaches miss a substantial proportion of individuals with active TB disease, particularly those who are asymptomatic or unable to produce sputum. Missed and delayed diagnoses drive ongoing transmission and undermine global TB elimination goals.\n\nRecent evidence has shown that diagnostic tools which are more accessible, even if somewhat less sensitive, can still substantially improve TB case detection by reducing diagnostic loss associated with access barriers. This suggests that near point-of-care (NPOC) tests might be highly cost-effective in many settings, because the gains from earlier diagnosis, reduced delays, and broader reach could outweigh losses from slightly lower accuracy.\n\nThe purpose of this study is to evaluate new, symptom-agnostic screening and diagnostic approaches that can be implemented at lower-level health facilities in high TB-burden, low and middle-income (LMIC) countries for adults ≥15 years and 10-14 years old young adolescents",[30],[91,92],"TB","Diagnostics","2026-04-01",{"date":95,"type":35},"2026-04-08",{"date":97,"type":22},"2026-04",{"date":99,"type":22},"2027-05",{"name":101,"class":73},"Liverpool School of Tropical Medicine",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100605609","parent-study-name-pulmonary-rehabilitation-to-reduce-post-tuberculosis-morbidity-tb-pure-100605609","NCT07164742","Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)","Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB PURE) A Randomized Multi-Centre Trial","TB Pure","Inclusion Criteria:\n\n* Age at least 18 years\n* Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease\\*\n* Not completed more than 2 weeks of TB treatment\n* Receiving TB care at the outpatient clinics at the TB PuRe study sites\n* Willingness to complete 48 weeks of study evaluations.\n* Access to a smartphone.\n\nExclusion Criteria:\n\n* Modified Medical Research Council score of 0 points (dyspnea only with strenuous exercise)\n* Multi or extensively drug-resistant TB disease\\*\n* Extrapulmonary TB disease at any clinical sites without pulmonary involvement\n* TB meningitis or TB of the spine\n* Symptomatic cardiovascular disease, including coronary artery disease, arrhythmias and congestive cardiac failure.\n* Karnofsky Score \\\u003C 40 points\n* Any medical condition that prevents pulmonary rehabilitation eg: fracture of lower\u002Fupper limbs\u002Fpregnancy\n* Bronchodilators and\u002For corticosteroids inhaled or otherwise.",{"count":111,"type":22},690,[87],"Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity. Randomization will occur in a 1:1:1 ratio at the initiation of treatment.",[30,91,115],"TB Infection",[117,118,119,120],"pulmonary tuberculosis","Pulmonary Rehabilitation","post-tuberculosis respiratory morbidity","Drug-sensitive TB","2026-03-25",{"date":123,"type":35},"2026-03-27",{"date":125,"type":35},"2026-03-18",{"date":127,"type":22},"2028-09-15",{"name":129,"class":73},"Johns Hopkins University",2,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100625303","start4all---start-taking-action-for-tb-diagnosis-dare-tb-100625303","NCT07420881","Start4All - Start Taking Action for TB Diagnosis (DARE-TB)","Start 4 All - DARE-TB","S4A-DARE-TB","Inclusion Criteria:\n\n1. Age:\n\n   * Adults aged 15 years and above\n   * Young adolescents aged 10-14 years\n2. Community setting:\n\n   o Rural and urban poor, elderly, marginalized groups, internally displaced persons (IDP) in camps and host communities, nomadic communities, and contacts of people with TB who attend community-based case finding (CBCF) campaigns.\n3. Screening eligibility:\n\n   * Screen positive on CAD CXR-AI (CAD score threshold ≥ 0.3).\n4. Consent:\n\n   * Written informed consent (and assent for adolescents if recruited) must be obtained according to local ethics and regulatory requirements.\n\nExclusion Criteria:\n\n1. Age o Below 10 years at enrolment\n2. Screening eligibility\n\n   o Do not screen positive with CAD CXR-AI (CAD score threshold \\\u003C0.3).\n3. Consent and follow-up\n\n   o Unable or unwilling to provide written informed consent (and assent where applicable) or unwilling to agree to follow-up visits.\n4. Current TB treatment\n\n   o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment.\n5. Recent TB preventive therapy\n\n   o Receipt of TB preventive therapy within the last 6 months prior to enrolment.\n6. Clinical danger signs\n\n   o Presence of severe illness at screening, including but not limited to:\n\n   ▪ Respiratory rate \\>30\u002Fmin St\n   * Fever \\>39°C\n   * Pulse rate \\>120\u002Fmin\n   * Inability to walk unaided\n7. Duplicate enrolment o Previous enrolment in DARE-TB.",{"count":140,"type":22},60000,[87],"DARE-TB has been designed to address critical evidence gaps on the diagnostic performance and operational value of near point-of-care (NPOC) nucleic acid amplification tests (NAATs) within community-based case finding (CBCF) strategies. Although World Health Organization (WHO) recommends wider access to molecular testing, its use remains concentrated in facility-based settings well short of the global targets and largely dependent on sputum production. This creates a substantial diagnostic gap for people reached through community screening who either cannot provide sputum or whose sputum specimens cannot be tested on a NAAT at a facility, particularly for marginalized, hard-to-reach populations with poor access to healthcare.",[30],[91,92],"2026-02-11",{"date":147,"type":35},"2026-02-19",{"date":149,"type":22},"2026-03-01",{"date":151,"type":22},"2027-10-01",{"name":101,"class":73},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":50,"sex":17,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":173,"leadSponsor":174,"locationsCount":4},"100612041","start-taking-action-for-tuberculosis-in-kids-100612041","NCT07248423","Start Taking Action for Tuberculosis in Kids","Evaluating the Performance, Feasibility, Acceptability and Cost Effectiveness of Concurrent Testing Including Novel Diagnostics, Non-sputum Specimens and Computer-aided Detection Interpretation of Chest X-ray for Childhood Tuberculosis in Bangladesh, Cameroon, Kenya and Viet Nam.","Start4Kids","Inclusion Criteria:\n\n1. Age 14 and below on the day of assessment\n2. Fulfils the criteria of presumptive TB according to the definition 10.1 of the protocol, or TB associated risk factors according to the definition 10.2. of the protocol\n3. Diagnosed with TB disease\n\nExclusion Criteria:\n\n1. On treatment for TB disease at the time of evaluation\n2. Parent or guardian does not allow the child to participate in the study or declines to sign the ICF.\n3. The child does not wish to participate in the study or declines to sign the Assent Form (where applicable)","0 Years","15 Years",{"count":164,"type":22},7920,[87],"Start4Kids: Evaluating the performance, feasibility, acceptability and cost effectiveness of computer-aided detection (CAD) of chest X-ray (CXR) and concurrent testing using novel diagnostics and non-sputum specimens for childhood tuberculosis (TB) in Bangladesh, Cameroon, Kenya and Viet Nam.",[30],[91,92],"2025-11-18",{"date":171,"type":35},"2025-11-25",{"date":149,"type":22},{"date":151,"type":22},{"name":101,"class":73},{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":50,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100555368","introduction-of-dispersible-3hp-formulations-for-tb-preventive-treatment-in-children-a-multi-country-evaluation-100555368","NCT06511180","Introduction of Dispersible 3HP Formulations for TB Preventive Treatment in Children: a Multi-country Evaluation","Clinic record review\n\nInclusion Criteria:\n\n* Medical records of children \\\u003C12 years who are either CLHIV or who are household contacts of people with pulmonary TB and who are initiated on TPT\n\nExclusion Criteria:\n\n* Records will be excluded for children who are contacts of a drug-resistant, have presumptive TB disease or are currently on TB treatment\n\nQualitative study\n\nInclusion Criteria:\n\n* Adult caregiver (\\>18 years) of a child \\\u003C12 years of age who is eligible for TPT\n* Healthcare worker from one of the clinics in which the study will be conducted who sees outpatient pediatric consultations including TB-exposed children\n* Policy maker or program manager who manages or is involved in PMTCT, TB and\u002For pediatric programming\n\nExclusion Criteria:\n\n* Any adult caregivers, healthcare workers, policy makers or program managers who are unable or unwilling to provide informed consent for both the interview and audio-recording.",{"count":182,"type":22},1200,"The WHO has recommended TB preventive therapy (TPT) for children living with HIV (CLHIV) and household contacts of people living with TB, however, the scale-up and implementation of TPT has been sub-optimal globally particularly in children. A safe and effective short-course TPT regimen, 3HP (rifapentine and isoniazid given once weekly for three months), is available but there is a lack of child-friendly formulations resulting in increased pill burden and there is a need to improve acceptability and adherence among children. The introduction of a dispersible rifapentine formulation has potential to improve uptake, treatment adherence and completion.\n\nOverall goal is to generate critical knowledge to improve delivery of TPT and, more specifically, of dispersible 3HP, in children in routine programs.\n\nThis evaluation will create an important understanding of TPT uptake and completion among children and assess the impact of the introduction of a dispersible 3HP formulation. These results will provide actionable information for improving service delivery and the scale-up of TPT in the respective countries.",[30,185,28,186],"Household Contact","Children, Only","2024-07-16",{"date":189,"type":35},"2024-07-19",{"date":191,"type":22},"2024-08",{"date":193,"type":22},"2025-06",{"name":195,"class":73},"The Aurum Institute NPC"]