[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tuberculosis-multidrug-resistant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tuberculosis-multidrug-resistant":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,78,103,134,155],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":4,"leadSponsor":43,"locationsCount":46},"100149071","training-protocol-on-the-natural-history-of-tuberculosis-100149071",false,"NCT01212003","Training Protocol on the Natural History of Tuberculosis","Natural History of Tuberculosis","* INCLUSION CRITERIA:\n\nFOR ALL PATIENTS\n\nPatients may be included in this study who:\n\n* Have or are suspected to have TB infection.\n* Are aged 2 years or older.\n* Have a primary care physician, infectious diseases physician, pulmonologist, or TB specialist outside of the NIH who can provide care of his or her TB infection outside the NIH, provide directly observed therapy (DOT) if necessary, and monitor for side effects and toxicity of TB medications.\n* Are willing to consent to storage of specimens for future research.\n* Able to provide informed consent for themselves or, if they lack the capacity to provide informed consent, have an appropriate Legally Authorized Representative (LAR; the study team will comply with NIH Human Research Protection Program \\[HRPP\\] Policy 403).\n\nFOR PATIENTS WITH LATENT TB\n\nIn addition to the above-described inclusion criteria for all patients, patients may be included in the Latent TB part of this protocol who:\n\n-Have documented evidence of a positive purified protein derivative (PPD) skin test or Interferon-gamma Release Assays (IGRA) test meeting American Thoracic Society (ATS)\u002FCDC guidelines for latent TB; conversion can have occurred at any time.\n\nFOR PATIENTS WITH ACTIVE TB\n\nIn addition to the above-described inclusion criteria for all patients, patients may be included in the Active TB part of this protocol who:\n\n* Have active TB of any drug susceptibility pattern and any site of infection as determined by smear, culture, or biopsy.\n* Have appropriately documented clinically suspicious active TB without definitive microbiology confirmation.\n\nEXCLUSION CRITERIA:\n\nPatients will be excluded from this study who:\n\n* Are incarcerated.\n* Have been ordered by a court to take TB medications.\n* Are unwilling or unable to comply with prescribed therapy.\n* Are pregnant.\n\nEXCLUSION OF SPECIFIC POPULATIONS\n\nChildren: Children under the age of 2 are not eligible to enroll. The addition of the very young will not provide enough additional insights to justify the risk to this specific population.\n\nPregnant women: Pregnant women are not eligible for participation in this protocol because the study objectives can be achieved without the enrollment of this population. Enrolled participants who become pregnant during the study will be withdrawn.","ALL","2 Years","100 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","Background:\n\n\\- Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies.\n\nObjectives:\n\n\\- To collect blood and other samples to study the natural history of tuberculosis.\n\nEligibility:\n\n\\- Individuals 2 years of age and older who have either active or latent tuberculosis.\n\nDesign:\n\n* Latent TB patients: Participants will have a single study visit with a physical examination and medical history, and will provide blood samples for testing.\n* Active TB patients: Participants will have an initial visit with a physical examination and medical history, and will provide blood samples for testing. Participants will also provide sputum samples if required, and may have an optional skin punch biopsy to collect a sample of skin tissue for study.\n* Treatment for active TB will be provided as part of this protocol.\n* Active TB participants may be asked to return for study visits every 1-2 months while receiving treatment....",[25,26,27,28,29],"Mycobacterium Infections","Tuberculosis, Multidrug-Resistant","Latent Tuberculosis","Tuberculosis","Extensively Drug-Resistant Tuberculosis",[31,32,33,27,34,35,28],"TB","Mycobacterium Tuberculosis","Active Tuberculosis","MDR TB","Natural History","RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":40},"2011-06-30",{"name":44,"class":45},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100236290","phase-2-pharmacokinetic-study-to-evaluate-anti-mycobacterial-activity-of-tmc207-in-combination-with-background-regimen-br-of-multidrug-resistant-tuberculosis-mdr-tb-medications-for-treatment-of-childrenadolescents-with-pulmonary-mdr-tb-100236290","NCT02354014","Pharmacokinetic Study to Evaluate Anti-mycobacterial Activity of TMC207 in Combination With Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for Treatment of Children\u002FAdolescents With Pulmonary MDR-TB","A Phase 2, Open-label, Multicenter, Single-arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Anti-mycobacterial Activity of TMC207 in Combination With a Background Regimen (BR) of Multidrug Resistant Tuberculosis (MDR-TB) Medications for the Treatment of Children and Adolescents 0 Months to \u003C18 Years of Age Who Have Confirmed or Probable Pulmonary MDR-TB","Inclusion Criteria:\n\n* Participant must be a boy or girl, aged from birth (0 months) to less than (\\\u003C) 18 years at screening. Participants in Cohort 4 who are \\\u003C6 months of age at screening, gestational age at birth had to be greater than or equal to (\\>=) 37 weeks\n* Participant must weigh \\>3 kilogram (kg) at baseline and be within the 5th and 95th percentiles (inclusive) for the participant's age, based on the World Health Organization (WHO) child growth standards; Body Mass Index (BMI) for age. In Cohorts 3 and 4, weight for height\u002Flength may be used instead of BMI for age according to the local standard of care. Per WHO guidance, for participants aged \\\u003C 2 years in Cohort 4, length will be used to calculate the BMI instead of height\n* For Cohorts 1 and 2 only: Heterosexually active girls may participate if they are of non-childbearing potential, or if they are using effective birth control methods and are willing to continue practicing birth control methods throughout Multidrug Resistant Tuberculosis (MDR-TB) treatment and for 6 months after stopping TMC207 treatment, or if they are non-heterosexually active or willing to practice sexual abstinence throughout MDR-TB treatment\n* For Cohorts 1 and 2 only: Boys who engage in sexual activity that could lead to pregnancy of the female partner must use at minimum a male condom throughout MDR-TB treatment and for 3 months after stopping TMC207 treatment\n* Participant must have confirmed or probable (clinically diagnosed or presumed) pulmonary and\u002For non-severe extrapulmonary MDR-TB, including pre-extensively drug-resistant TB (pre- extensively drug resistant \\[XDR\\]-TB) or XDR-TB infection, based on the case definitions of pediatric pulmonary and non-severe extrapulmonary TB as described in the International (WHO) guidelines and in accordance with the local standard of care\n* Participants must be starting the initial MDR-TB treatment at Day 1 or have started an MDR-TB treatment within 12 weeks of Day 1 and are willing to modify it if necessary to an acceptable MDR-TB regimen for use with TMC207\n* Participant must be willing to permanently discontinue RMP from at least 7 days before the baseline visit\n* Participant or legally acceptable representative must consent\u002Fassent to human Immunodeficiency virus (HIV) testing of the participant. The mother must also consent to testing of her own HIV status, if the potential participant is a child aged \\\u003C2 years, or if the participant is \\>= 2 years old and being breastfed or was breastfed within the last 8 weeks before screening, unless the mother had HIV test performed within 1 month prior to screening and documentation of HIV status can be provided. When documented HIV-positive status is available prior to screening for participants in Cohort 4 or their mother, HIV testing for the participant and mother is not required\n\nExclusion Criteria:\n\n* Participant has a clinically significant active medical condition or the presence of any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency (except HIV infection), which in the opinion of the investigator would prevent appropriate participation in the study, or that would make implementation of the protocol or interpretation of the study results difficult, or otherwise make the subject a poor candidate for a clinical study\n* Participant is a girl who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 6 months after stopping TMC207 treatment\n* Participant has known or presumed forms of extrapulmonary TB, other than: Lymphadenopathy (peripheral nodes or isolated mediastinal mass without significant airway compression); Pleural effusion or pleural fibrotic lesions\n* Participant has a significant cardiac arrhythmia that requires medication or risk factors for Torsade de Pointes, example heart failure, hypokalemia, known personal or family history of Long QT Syndrome, and untreated hypothyroidism","0 Months","18 Years",{"count":57,"type":21},60,"INTERVENTIONAL",[60],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in children and adolescents (0 months to less than \\[\\\u003C\\] 18 years of age) diagnosed with confirmed or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in combination With a Background Regimen (BR) of MDR-TB Medications.",[26],[64,65,66],"Multidrug-Resistant Tuberculosis","Bedaquiline","TMC207","2026-06-04",{"date":69,"type":40},"2026-06-05",{"date":71,"type":40},"2016-05-03",{"date":73,"type":21},"2028-11-02",{"name":75,"class":76},"Janssen Research & Development, LLC","INDUSTRY",11,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":58,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":46},"100439861","test-to-treat-tb-impact-of-sputum-sequencing-guided-individualised-therapy-on-outcomes-in-drug-resistant-tuberculosis-100439861","NCT05007795","Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis","Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis (TB): a Proof of Concept Randomized Controlled Trial","T3-RCT","Inclusion Criteria:\n\nSubjects are required to meet ALL of the following inclusion criteria to participate:\n\n* Newly diagnosed culture and\u002For Xpert\u002FMTB Ultra positive pulmonary TB\n* Rifampicin resistance detected using GeneXpert\n* Provide written informed consent prior to all trial-related procedures\n* Male or female aged 18 years and older.\n* Patients on TB treatment for less than or equal to 7 days.\n* Patients receiving both the shorter and longer MDR-TB regimen will be eligible.\n\nExclusion Criteria:\n\nSubjects will be excluded from participation if they meet ANY of the following criteria:\n\n* A subject who in the opinion of the investigator is unlikely to cope with regular visits to the trial site either because of travel constraints, or drug or alcohol abuse, or other reason.\n* Currently on MDR-TB treatment and completed 7 days of treatment.\n* Any participant with a clinically significant pre-existing medical condition that, in the opinion of the investigator, may be significantly worsened by the patient's participation in the study\n* Any subject with a Karnofsky score \\\u003C 50.\n* Having participated in other clinical studies within 8 weeks prior to trial start where investigational agents were used that may potentially impact current trial outcome.\n* Participant who is pregnant, breast-feeding (and not willing to stop), or planning to conceive a child within 6 months of cessation of treatment.\n* Any pre-existing laboratory abnormality, which in the opinion of the investigator will place the participant at risk (see detailed protocol for grade of abnormality).",{"count":87,"type":21},280,[89],"NA","Resistance to anti-tuberculosis drugs is a continually growing problem. Multidrug-resistant tuberculosis (MDRTB) is resistance to at least rifampicin and isoniazid, and extensively drug-resistant TB is additional resistance to a fluoroquinolone and a second injectable line drug. Methods currently employed in testing for resistance are inadequate and a contributing factor to the 40-50% MDR-TB treatment success rate. Current drug susceptibility testing methods are slow for most drugs, taking weeks. Rapid molecular methods such as the line probe assays, e.g. Hain GenoType MDRTBplus and sl, provide resistant calls to only a limited number of drugs, and are often less useful in smear negative patients.\n\nMolecular technologies such as sequencing can provide a comprehensive readout of drug resistance and are able to detect resistant populations at very low levels (≤1%), thus enabling individualized therapy. This can be done directly from sputum. Targeted sequencing amplifies regions of genomic DNA associated with resistance prior to sequencing. Rapid analytic software is used to process the raw sequence data, identify resistance causing mutations and provide a readout of clinically relevant information. However, the feasibility, and more importantly the impact, of this approach has not been evaluated in a clinical trial to establish proof of concept.\n\nAim 1: To conduct a randomised controlled trial to determine the impact of sputum-based targeted sequencing in detecting resistance to second-line TB drugs compared to the current programmatic standard of care (Hain MDRTBplus\u002Fsl and adjunct phenotypic drug susceptibility testing) when used to inform of treatment for MDR-TB.\n\nAim 2: To compare currently available drug resistant sequencing pipelines for diagnostic accuracy, sensitivity, specificity and predictive value as compared to culture based phenotypic drug susceptibility testing.\n\nAim 3: To compare the feasibility, accuracy, turn-aroundtime, and cost implications of the above-mentioned diagnostic approaches.",[26],"NOT_YET_RECRUITING","2026-05-05",{"date":95,"type":40},"2026-05-06",{"date":97,"type":21},"2026-06-01",{"date":99,"type":21},"2028-10-30",{"name":101,"class":102},"University of Cape Town","OTHER",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":58,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":5},"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":113,"type":21},400,[60,115],"PHASE3","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.",[118,26,119],"Tuberculosis, Pulmonary","Tuberculosis, MDR",[28,121,65,122,123,124],"BPaLM","Pretomanid","Linezolid","Moxifloxacin","2026-01-15",{"date":127,"type":40},"2026-01-20",{"date":129,"type":40},"2025-10-03",{"date":131,"type":21},"2031-08",{"name":133,"class":102},"University of California, San Francisco",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":4,"enrollmentInfo":142,"targetDuration":17,"studyType":22,"phases":4,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100567907","registry-on-the-effectiveness-and-safety-of-the-9-month-mdr-end-treatment-regimen-in-korean-patients-with-fq-sensitive-mdr-tb-mdr-end-registry-100567907","NCT06674291","Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)","Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen (Delamanid, Linezolid, Levofloxacin, Pyrazinamide) in Korean Patients with Fluoroquinolone-Sensitive Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) : a Non-interventional, Prospective Observational Study (MDR-END Registry)","Inclusion Criteria:\n\n1. Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis\n2. Adults prescribed MDR-END regimen according to the Korean Guidelines for Tuberculosis after being informed of this study from the investigator and signing an informed consent form\n\nExclusion Criteria:\n\n1. Patients with confirmed quinolone resistance\n2. Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide\n3. Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide\n4. Patients with or with a history of optic neuritis or peripheral neuritis\n5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n6. Pregnant or lactating women\n7. Women of childbearing potential who are unwilling to use appropriate contraception during the study treatment","19 Years",{"count":143,"type":21},222,"This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.\n\nIt will be conducted as a non-interventional, prospective, single group, multicenter design.\n\nSubjects who are considered to meet the inclusion \u002Fexclusion criteria will receive MDR-END regimen for 9 months (or 12 months) during the treatment period according to the 5th edition of the Korean Guidelines for Tuberculosis, and will be followed-up for 12 months after the end of treatment.",[26],"2024-11-03",{"date":148,"type":40},"2024-11-05",{"date":150,"type":21},"2024-11-30",{"date":152,"type":21},"2028-12-31",{"name":154,"class":76},"Korea Otsuka Pharmaceutical Co., Ltd.",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":46},"100440970","hotspots-households-and-hospitals-enhanced-drug-resistant-tuberculosis-case-finding-in-namibia-100440970","NCT05022238","Hotspots, Households and Hospitals: Enhanced Drug-resistant Tuberculosis Case Finding in Namibia","H3TB","Inclusion Criteria:\n\n* All cases diagnosed with drug-resistant TB in Namibia, in three regions of Khomas, Otjozondjupa and Ohangwena will be included for the first outcome. For the second outcome, all household members of DR-TB cases will be included; all hospital visitors to DR-TB cases will be included and community members at transmission hotspots will be included.\n\nExclusion Criteria:\n\n* Anyone who does not give consent to participate.",{"count":163,"type":21},2100,"Poor case management, pharmacokinetic variability and on-going transmission have fostered the drug-resistant tuberculosis (DR-TB) epidemic leading to a global estimated number of \\>500,000 new multidrug resistant (MDR) TB cases per year, of which roughly 10% are extensively drug resistant (XDR). Namibia is a high TB burden country with an incidence rate of 446\u002F100,000 in 2016; about 11,000 new cases per year. 3.9% of new cases and 8.7% of previously treated cases have MDR-TB. Whole genome sequencing (WGS) has recently been applied to interrogate the complete genetic code of Mycobacterium tuberculosis (Mtb) strains. WGS can be used to infer relationships between identified strains as well as determine genomic variations involved in resistance development.\n\nThe specific aims of the H3TB study are to: (i) characterise the DR-TB epidemic, in terms of clinical, epidemiological, geospatial, social network and laboratory data, to identify transmission hotspots in three regions of Namibia, (ii) evaluate the feasibility of targeted case finding intervention strategies to improve DR-TB control in highly affected populations and (iii) develop a transmission model to investigate the potential impact of the case finding intervention strategies on DR-TB incidence in Namibia.\n\nA prospective surveillance study started in January 2020, which includes all DR-TB cases in Namibia, and which will nest H3TB. Data collection tools and other study implementation tools have been designed and implemented. The study team is working in close collaboration with the National Institute of Pathology, where all DR-TB cases from the country are registered, to ensure all possible cases are captured. This is important for the identification of transmission hotspots.\n\nAfter HREC and MOHSS approval, individuals with GeneXpert® MTB\u002FRIF rifampicin-resistant samples and a positive Mtb culture from three regions in Namibia will be included in a transmission hotspot identification study. Preliminary data have shown that DR-TB clusters exist in these regions. Clinical, epidemiological, geospatial, social network and laboratory data (GeneXpert® MTB\u002FRIF, culture, drug sensitivity tests) will be collected. WGS capacity has been established at the UNAM research laboratory, where WGS will be performed on the samples of H3TB participants; results will be validated at the Research Center Borstel in Germany. These study results in conjunction with a systematic review and meta-analysis will inform the design of case finding interventions which will be evaluated through a mixed-methods feasibility study conducted at high transmission areas (hotspots, households and hospitals). Data from these studies and the TB programme will be used to develop the model which will include a health economics component.\n\nThe study will strengthen DR-TB diagnosis, surveillance and control, inform DR-TB case finding policy in Namibia and regionally, inform resource allocation by identifying high transmission areas and create preliminary data to design a large scale DR-TB case finding intervention.",[26],[167,168],"case-finding","Namibia","2024-10-22",{"date":171,"type":40},"2024-10-24",{"date":173,"type":40},"2022-08-01",{"date":175,"type":21},"2026-09",{"name":177,"class":102},"University of Namibia"]