Title of study Summary and Purpose Field/research Study type Study design Intervention Study location Sponsor, collaborator and Study population/condition Sample size Available source of investigator information (website, trial identity code)
Video Directly Observed Therapy A novel mHealth application that allows patients to make Adherance and completion Interventional Allocation: Randomized Video Directly Observed Therapy, USA Sponsor: (VDOT) to Monitor Short-Course and send videos of each medication dose ingested that are in treatment Endpoint Classification: Efficacy In-Person DOT (Control) TB contacts and refugees in San LTBI Treatment watched by healthcare providers via a HIPAA-compliant Study University of California, San Diego Diego who are prescribed 3HP for website to remotely monitor LTBI treatment adherence Intervention Model: Parallel LTBI treatment by their physician 310 NCT02641106 (Video DOT [VDOT]) has been developed. This study will Assignment will be randomly assigned to be determine whether monitoring patients with VDOT achieves Masking: Open Label monitored for adherence via higher treatment completion rates and greater patient either VDOT or in-person DOT acceptability at lower cost than clinic-based in-person DOT. Quantiferon Gold Test for Detecting To compare the effectiveness of linking the Quantiferon-gold Performance of comercially Interventional Allocation: Randomized South Africa Sponsor: TB Infection in HIV/AIDS Patients in in-tube test (QGIT) with routine CD4 testing to the routine available immunotests Intervention Model: Parallel South Africa use of the tuberculin skin test (TST), the current standard of Assignment Johns Hopkins University care for diagnosing latent tuberculosis infection (LTBI) in Masking: Open Label South Africa. The investigators hypothesize that QGIT clinics Primary Purpose: Diagnostic Collaborators: will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher proportion of patients and in a significantly Device: QGIT National Institute of Allergy and 3000 NCT02119130 faster timeframe. The cost-effectiveness of linking QGIT Infectious Diseases (NIAID) with routine CD4 compared to routine TST will also be evaluated, University of Witwatersrand, South Africa
Vitamin D Suplementation in TB The goal of this clinical trial is to investigate the preventive Treatment/intervention Phase 3, Allocation: Randomized •Dietary Supplement: Not provided Healthy children ages between Prevention role of vitamin D supplementation in school age children in a Intervention Model: Parallel cholecalciferol (vitamin D) 6 and 13 years, enrolled in high transmission setting. The investigators hypothesis is Interventional Assignment 14000 IU vitamin D3 weekly Sponsor: participating schools 8200 NCT02276755 that (1) vitamin D supplementation will reduce rate of Masking: Double Blind (Subject, Experimental group will receive Harvard School of Public Health Not currently TB infected. acquisition of LTBI, (2) vitamin D supplementation will lead Caregiver, Investigator, vitamin D supplement (Tishcon, to greater reductions in active TB incidence, and (3) children Outcomes Assessor) USA). Toward a Safe and Reachable Thewith incidence the lowest of vitamin TB in Taiwan D status has at gradually baseline declinedwill gain mostin Treatment/intervention Interventional PhasePrimary 3 Purpose: Allocation: Prevention Randomized Rifapentine and Isoniazid for 3 months Taiwan Preventive Therapy for LTBI: a recent 10 years. In order to maintain the trend of decreasing Endpoint Classification: versus Isoniazid for 9 months Multicenter Randomized Controlled in incidence, preventive therapy for LTBI become more and Safety/Efficacy Study Study in Taiwan more important. However, which is the best preventive Intervention Model: Parallel regimen for LTBI is still unknown. Therefore, we conduct the Assignment Sponsor: 322 NCT02208427 prospective randomized multicenter studies to compare the Masking: Open Label National Taiwan University Hospital treatment completion rate of two regimens in Taiwan. The Primary Purpose: Prevention first regimen is daily isoniazid for 9 months. The second is weekly rifapentine plus high-dose isoniazid for 3 months.
Study based in Southern Ethiopia Purpose - to explore if Performance of comercially Observational Observational Model: Defined Not provided Ethiopia Sponsor: children in contact with adults with TB have positive acute available immunotests Population Liverpool School of Tropical Medicine reactants such as IFN-y and other cytokine responses; if Time Perspective: Longitudinal Children with suspicion of TB these responses discriminate between high and low risk of Collaborator: attending health centres will 500 Diagnosis of Active and Latent TB disease progression and whether these could be Thrasher Research Fund also be investigated NCT00456469 Infection With IFN-y Assays in incorporated into improved diagnostic approaches. African Children The Role of Apoptosis Associated The apoptosis-associated markers, including Fas ligand, Development of new tests Observational Observational Model: Case Not provided Taiwan Markers in Pathogenesis of Decoy-receptor 3, Lipoxin, and prostaglandin E2, are with improved performance Control 1.Patients with tuberculosis: Pulmonary Tuberculosis discriminative in patients with active TB from those with LTBI and biomarkers Time Perspective: Prospective microbiology or pathology and thus might predict the potential of being active TB from proven tuberculosis infection LTBI. To compare the serum apoptosis-associated markers 2.Patients with latent between patients with active TB and patients with LTBI To tuberculosis infection are defined by interferon-gamma evaluate the efficiency of apoptosis-associated markers to National Taiwan University Hospital 400 NCT01676155 differentiate potential of active TB from LTBI release assay 3.Patients without tuberculosis and latent tuberculosis are defi=ed by negative findings in above-mentioned results Prognostic Value of Interferon The objective of this study is to assess the efficacy of the two Programme management Observational Observational Model: Cohort Not provided United Kingdom Sponsor: Gamma Release Assays in Predicting current TB (tuberculosis) blood tests (Interferon Gamma Time Perspective: Prospective Active Tuberculosis Among Release Assays (IGRA)) compared with the standard skin test Public Health England Individuals With, or at Risk of, (Mantoux Tuberculin Skin Test (TST)), for predicting active Latent Tuberculosis Infection tuberculosis among those at increased risk of TB. Those at Collaborators: Those who are close contacts increased risk are defined as either newly arrived immigrants of active tuberculosis cases or or people who have been in contact with TB cases. The study Imperial College London those who have are new 10000 NCT01162265 will also provide information on the cost effectiveness of entrants to the UK from high different testing strategies, such as the two step testing Queen Mary University of London incidence countries approach recommended by NICE. (>40/100000). University College, London
Brunel University
University of Birmingham Study to Evaluate the Tolerability This is a double-blind, masked, compared with placebo Treatment/intervention Interventional Phase 1 Allocation: Dietary Supplement: Nyaditum Sponsor: and Immunogenicity of Nyaditum clinical trial in pediatric population in contact with Randomized, Endpoint resae ® 10e5 of heat-killed Resae ® Probiotic Administered to tuberculosis with or without tuberculosis infection. This trial Classification: Safety/Efficacy Mycobacterium manresensis Spain Manresana de Micobacteriologia, SL Pediatric Population in Contact aims to study the effect of the probiotic Nyaditum resae® at Study, Intervention Model: Other: Placebo With Tuberculosis With or Without the level of specific Treg memory cells eight weeks after the Parallel Assignment, Masking: Latent Tuberculosis Infection first administration, and the global tolerability of the Double Blind (Subject, Caregiver, Child between 2 and 17 years, treatment. Investigator), Primary Purpose: who have had contact with 24 NCT02581579 Nyaditum resae® is a preparation in the form of capsules Prevention tuberculosis containing heat-killed environmental mycobacteria Mycobacterium manresensis. The overall objective of the study is the effect of Nyaditum resae® on immunity, which could reduce the risk of developing active tuberculosis.
Immune Responses to To study how the immune system of people with latent Other (immunology, Observational United States Sponsor: National Institute of Allergy Mycobacterium Tuberculosis (Mtb) tuberculosis infection (LTBI) acts to prevent development of pathogenesis, co-infection) and Infectious Diseases (NIAID) in People With Latent Tuberculosis active TB. Also, to study how helminth infection might affect Infection With or Without this immune response. An exploratory objective is to The study will enrol Concomitant Helminth Infection evaluate if there are subsets of subjects within the LTBI 250 NCT02225158 participants with LTBI group (irrespective of helminth infection status) who have Study Design: stable pool of long lasting antigen-specific IL-2 only producing CD4+ central memory T cells and changes to this Time Perspective: Prospective pool after receiving LTBI treatment.
Randomised controlled trial for cost- The aim of this study is to perform a multimodal comparison Programme management Interventional Randomised controlled trial A 12 dose course of weekly Australia Sponsor: Hospital Melbourne Health benefit of short-course isoniazid of 3-month courses of weekly isoniazid and rifapentine (3HP) Parallel isoniazid (900mg) and rifapentine and rifapentine versus 9-month with 9 months of daily isoniazid (9H) for latent tuberculosis Phase: Phase 4 (900mg) tablets. course of isoniazid in latent infection, using a variety of indices: Persons with clinical indication tuberculosis infection for latent tuberculosis infection 80 ACTRN12613000599774 a. Cost-benefit (LTBI) treatment. b. Patient satisfaction c. Adherence to prescribed therapy
Effect of Filarial Infection on Researchers want to study people with latent tuberculosis Other (immunology, Observational Time Perspective: Cross-Sectional not provided United States Sponsor: Eligibility: Immune Responses in Latent (TB) who may or may not be infected with filariasis. This pathogenesis, co-infection) Tuberculosis study will look at the way that people with latent TB fight National Institute of Allergy and - Individuals between 18 and infection with these worms. Infectious Diseases (NIAID) 65 years of age who have 4000 NCT01547884 latent TB and may or may not have filarial infection.
TB mHealth Study - Use of Cell This study will examine the impact of use of mobile phones Adherance and completion Interventional Phase 0 Allocation: Other: Cell phone text messages Canada Sponsor: Phones to Improve Compliance in and text messaging on adherence to treatment for patients in treatment Randomized Participants in the intervention Patients on LTBI Treatment with latent TB infection. Half (50%) of the 350 anticipated Intervention Model: Single Group arm will receive weekly text University of British Columbia study participants will receive weekly text messages Assignment messages from the TB control clinic inquiring on their health status in relation to their prescribed Masking: Open Label asking how they are. Collaborator: treatment, while the other half (50%) will not receive weekly Primary Purpose: Health Services text messages at all. Medical adherence will be assessed by Research British Columbia Cancer Agency monthly blood-work, clinic visits and by interviewing Inclusion Criteria: Are initiating treatment for patients at each of these visits. 350 NCT01549457 latent TB infection The investigators hypothesis is that enhanced communication with a health care provider, via a structured cell phone SMS text messaging based program (WelTel), will result in a 15% improvement in the proportion of patients who successfully complete their LTBI treatment regimens. Evaluating the Safety and HIV-infected people have an increased risk of developing Treatment/intervention Interventional Phase 3 Allocation: Dietary Supplement: Pyridoxine United States, Botswana, Sponsor: Effectiveness of Short-Course active tuberculosis (TB). The standard course of treatment Randomized, Intervention (Vitamin B6) Brazil, Haiti, Kenya, Rifapentine/Isoniazid for the for TB is 6 to 9 months of isoniazid (INH). A shorter course of Model: Parallel Assignment, Drug: Isoniazid (INH) Malawi, Peru, South National Institute of Allergy and Prevention of Active Tuberculosis in treatment may be as effective and potentially increase Masking: Open Label, Primary Drug: Rifapentine (RPT) Africa, Thailand, Infectious Diseases (NIAID) HIV + persons with latent TB 3000 NCT01404312 HIV-Infected Individuals With Latent treatment adherence. This study will compare the safety and Purpose: Prevention Zimbabwe Tuberculosis Infection effectiveness of a 4-week regimen of rifapentine (RPT) plus INH versus a standard 9-month regimen of INH in HIV- infected people who are at risk of developing active TB. Training Protocol on the Natural To provide better training for infectious disease staff Programme management Time Perspective: Prospective United States Sponsor: History of Tuberculosis members at the National Institutes of Health Clinical Center in Washington, D.C., researchers are interested in actively Observational National Institute of Allergy and recruiting individuals with TB for research and treatment Infectious Diseases (NIAID) studies. Objectives: •To provide staff at the National Institutes of Health Clinical 150 NCT01212003 Center with increased experience in hands-on treatment of individuals with tuberculosis, including drug-sensitive or drug-resistant forms of the disease. •To collect blood and other samples to study the natural history of tuberculosis.
Prospective Study of To validate the use of the RD1 based Exvivo IFNy ELISpot in Development of new tests Observational The RD1 based ex vivo enzyme UK-multicentre Sponsor: University of Oxford Mycobacterium Tuberculosis the immunodiagnosis of tuberculosis in iatrogenically with improved performance linked immunospot assay versus Specific Cellular immune Responses immunosuppressed populations by calculation of positive and biomarkers Tuberculin PPD RT 23 SSI for Renal failure and iatrogenic in Iatrogenically Immunosuppressed and negative predictive values for the assay and for a mantoux testing immunosuppression associated Patients: those undergoing TNF- comparator: the tuberculin based mantoux test. with solid organ EudraCT Number: 2005- alpha blockade or Awaiting Renal To investigate potential immune correlates of latency and transplantation or TNF alpha 005664-88 Trasnplants: A Potential New active disease in tuberculosis and identify potential markers blockade in rheumatoid Method For Accurate Diagnosis of of prognosis and disease progression in tuberculosis. arthritis Latent Tuberculosis Infection in Clinical Practice
The V-QUIN MDR TRIAL: A To assess the efficacy of preventive therapy (levofloxacin Treatment/intervention/M Interventional Six months of daily oral Vietnam NHMRC, Vietnam National randomized controlled trial of six versus placebo) in all contacts (adults and children) DR levofloxacin Treatment Program months of daily levofloxacin for Household contacts (adults, the prevention of tuberculosis Randomised controlled trial adolescents, and children 2006 ACTRN126000215426 among household contacts of Parallel down to 3 kg) of individuals patients with multi-drug resistant with MDR-TB tuberculosis
TB-CHAMP Treatment/intervention Interventional Multi centre phase III, double 24 weeks of daily levofloxacin South Africa Joint Global Health Trials Scheme of Child <5 years who is The lack of evidence on MDR-TB preventive therapy To assess the efficacy of blind RCT against 24 weeks of daily placebo the Department for International household contact of an makes it difficult to develop evidence-based guidelines, levofloxacin in the prevention of Development (UK), Wellcome Trust, enrolled adult MDR-TB case leading to 'recommendations' based on opinion only. If MDR-TB in child and adolescent Medical Research Council, South proven to be efficacious, safe, cost-effective, and household contacts of MDR-TB African Medical Research Council 1556 ISRCTN92634082 acceptable to families and the NTP, we anticipate that this cases. trial will inform global guidelines for post-exposure preventive therapy in child and adolescent contacts of MDR-TB. Prospective Comparison of the Performance of comercially Observational Observational Model: Cohort not provided 10 sites across the Tuberculosis Epidemiologic Studies Tuberculin Skin Test and available immunotests Time Perspective: Prospective United States Consortium II (TBESC II) Interferon-Gamma Release Assays in Diagnosing Infection With This is a prospective cohort study of persons tested for Mycobacterium Tuberculosis and latent tuberculosis infection at either high risk for High risk individuals for in Predicting Progression to exposure to Mycobacterium tuberculosis or high risk for latent TB, including children Tuberculosis and immunocompromised progression to tuberculosis disease. The study will assess 42647 NCT01622140 the relative performance and cost of three diagnostic tests persons. for latent tuberculosis infection (tuberculin skin test, QuantiFERON-TB Gold In-Tube, and T-SPOT.TB) and will examine the rates of positive results among the cohort. This study will also determine the risk and rate of progression to active TB disease, overall and by the results of the three tests. Randomized Clinical Trial The current standard regimen is 9 months of Isoniazid Treatment/intervention Interventional Phase 3 Allocation: Isoniazid versus Rifampin Australia, Benin, ponsor: Comparing 4RIF vs. 9INH for LTBI (9INH). This regimen has excellent efficacy if taken Randomized Brazil, Canada, Ghana, McGill University Treatment-effectiveness regularly, but its effectiveness is substantially reduced by Endpoint Classification: Guinea, Indonesia, Collaborator: poor compliance. Based on some evidence in treatment of Efficacy Study Korea, Republic of, Canadian Institutes of Health LTBI, and extrapolating from extensive experience with Intervention Model: Parallel Saudi Arabia Research (CIHR) Principal treatment of active TB, it is believed that 4RIF has similar Assignment Investigator: Dr. Dick Menzies efficacy as 9INH. Therefore, the investigators are Masking: Open Label 5720 NCT00931736 initiating the first multi-site international randomized Primary Purpose: Treatment trial that will compare the effectiveness of 4RIF and 9INH in preventing active tuberculosis. A Randomized Trial to Compare Once children are exposed and infected they are at very Treatment/intervention Interventional Phase 3 Drug: Isoniazid verus Rifampin Australia, Benin, Sponsor: Effectiveness of 4 Months high risk to develop active TB - which can be lethal if not Allocation: Randomized Brazil, Canada, Ghana, Rifampin (4 RIF) With 9 Months detected and treated promptly. This makes it very Endpoint Classification: Safety Guinea, Indonesia McGill University Isoniazid (9 INH) in the important to detect TB infection as soon as possible, and Study Prevention of Active TB in treat this while it is still latent or dormant. Current Intervention Model: Parallel Collaborator: Children: The P4v9 Trial therapy for latent TB infection is 9 months of Isoniazid; Assignment this is very effective if taken properly but because Masking: Open Label Canadian Institutes of Health Children (age <18) with treatment is so long many children do not finish this. Four Primary Purpose: Treatment Research (CIHR) documented positive TST (or months of Rifampin is a recommended alternative. It is in the absence of TST, a hypothesized that among children at high risk for Information provided by positive QFT or T-Spot) and 822 NCT00170209 development of active TB, intolerance/adverse events will (Responsible Party): prescribed preventive not be worse (non-inferiority), among those randomized treatment for LTBI to 4RIF compared to those randomized to 9INH. In Dr. Dick Menzies, McGill University addition completion of latent tuberculosis infection (LTBI) therapy will be significantly greater (superiority), and subsequent rates of active TB will not be significantly higher (non-inferiority) in children taking 4RIF.
Predictive Values of Next Currently available blood tests for latent tuberculosis Performance of comercially Interventional Single Group Assignment Procedure: blood test, not yet UK Sponsor: Generation Interferon Gamma infection (LTBI) identify people who have been previously available immunotests Open Label marketed, no trade name Release Assays for Latent infected with M. tuberculosis. Whilst they are sensitive Primary Purpose: Diagnostic blood test using the new TB Public Health England Adult contacts of Tuberculosis Infection and specific, they cannot be used to monitor the diagnostic test smearpositive pulmonary TB effectiveness of treatment for LTBI. New blood tests Collaborator: patients and patients with active TB. Hajj pilgrims: ("fourth generation Quantiferon tests") have not yet been 2000 NCT02512939 evaluated in clinical practice, so their usefulness in University College, London Individuals arranging travel identifying people at highest risk of TB disease and to Saudi Arabia for the Hajj monitoring treatment is unknown. through participating tour operators.
Early Detection and Management of Establishing a database of latent and active TB in Europe Programme management Observational Cohort Latent TB testing and treatment Multiple: UK, EU Third Health Programme Tuberculosis in the EU. starting with Italy, Sweden, the Netherlands and the UK to programmes Netherlands, Sweden, Chief investigator : Ibrahim Abu bakar E-DETECT TB inform epidemiological analysis and future interventions to Italy, Romania and Various https://e-detecttb.eu/ control TB. Bulgaria
CATAPULT Treatment of latent TB in primary care compared to Programme management Observational A cluster randomised controlled Treatment of LTBI in primary care UK Barts Charity secondary care trial Chief investigator: Heinke Kunts Migrants 780 NCT03069807 Co-aaplicant: Ibrahim Abubakar
Prognostic Study of the Interferon Predictive value of the two commercial IGRAs compared to Performance of comercially Observational Cohort Two commercial IGRAs (T-Spot TB UK Chief investigator: Ibrahim Abubakar Gamma Release Assay for TST available immunotests and Quantiferon, TST) Contacts, Migrants 10,000 NCT01162265 Tuberculosis (UK PREDICT TB) Biobank for substudies
Optimising approaches for LTBI Lessons learned from the different pilots will be used to Programme management Observational The Netherlands ZonMw (The Netherlands http://www.zonmw.nl/nl/p screening and preventive improve intervention within the specific target population. Organization for Health Research and rojecten/project-detail/tb- • Regular immigrants treatment. ZonMW Quantitative results from the pilots on uptake of LTBI Development) – Govt institution. endpoint-tuberculosis- • Asylum seekers TB ENDPoint screening and PT will be used as input to assess the long Multiple pilot studies Prospective elimination-in-the- LTBI intervention • Somali and Eritrean term impact in terms of costs and cases averted with cohort KNCV, RIVM, Municipal Health netherlands-through- population different LTBI strategies. Services, Universities disease-prevention- optimalization/samenvatti ng/ Evaluation of contact investigation Study is based on a previous evaluation report (2016-2010) Programme management Observational The Netherlands >60,000 contacts in the Netherlands (2006-2013). with more than 60,000 contacts screened (45,000 for LTBI) Retrospective cohort Evaluation KNCV LTBI cases ?? screened and 3,050 LTBI cases identified. To evaluate the predictive value of Assessing predicitive value of IGRA and to understand the Performance of comercially Observational The Netherlands IGRA results from 2008 - 2011 as a contributing risk factors towards progression of disease. available immunotests predicitve marker for progression to tuberculosis.
Retrospective cohort Evaluation KNCV LTBI cases 4000 ??
The trial test a complex intervention- a two phase Programme management Interventional Allocation: Randomized LTBI program evaluation & Benin, Brazil, Canada, programmatic public health package which includes a Intervention Model: Parallel diagnosis Ghana, Indonesia, standardized public health evaluation and analysis, to Assignment Vietnam identify problems and barriers limiting LTBI diagnosis and Masking: Open Label Enhancing the public health impact Sponsor: McGill University LTBI cases among household treatment among close contacts or active TB cases. Primary Purpose: Prevention of latent tuberculosis (TB) infection Collaborators: Canadian Institutes of contacts of patients with active 36 NCT02810678 diagnosis and treatment (ACT4) Health Research (CIHR) pulmonary TB Promoting adherence to treatment The purpose of this study is to determine whether regularly Programme management Interventional Allocation: Randomized Regularly scheduled LTBI United States for latent TB infection through text scheduled reminder text messages (SMS) are effective in Intervention Model: Parallel medication reminder text messaging increasing LTBI treatment completion. Assignment messages Masking: Single Blind Sponsor: University of Arizona Primary Purpose: Prevention Collaborators: Pima County Health Adult LTBI cases 250 NCT02690818 Department, American Lung Association
Screening latent tuberculosis Study the prevalence of LTBI in patients who are waiting Programme management observational Allocation: Randomized Screening for LTBI in patients who Taiwan infection and observing preventive renal transplant and monitor the incidence of active TB. Endpoint Classification: are waiting renal transplant and therapy in kidney transplantation Safety/Efficacy Study monitor the incidence of active TB. Intervention Model: Parallel Assignment Masking: Open Label Sponsor: National Taiwan University Renal transplant patients 800 NCT02782416 Primary Purpose: Screening Hospital
Impact of Once-Weekly Rifapentine The purpose of this study is to determine the effects of Treatment/intervention Interventional Endpoint Classification: dolutegravir (DTG); rifapentene United States National Institutes of Health Clinical and Isoniazid on the Steady State concomitant RPT and INH administration on the steady state Pharmacokinetics/Dynamics (RPT); darunavir/cobicistat (DRV/c); Center Pharmacokinetics of Dolutegravir PK of DTG and DRV/c. The use of weekly RPT plus INH is not Study Isoniazid (INH) and Darunavir boosted with currently recommended in adults infected with human Intervention Model: Single Group Healthy volunteers 60 NCT02771249 cobicistat in healthy volunteers immunodeficiency virus (HIV) on antiretroviral therapy (ART) Assignment due to limited evidence on drug interactions with Masking: Open Label antiretrovirals (ARVs). Dolutegravir (DTG) and darunavir boosted with cobicistat (DRV/c) comprise parts of first-line Taima TB: 3HP Study The primary objective of this study is to compare the Treatment adherance Interventional Phase IV 3 HP Canada Sponsor: Ottawa Hospital Research proportion of people who complete directly observed Intervention Model: Single Group Institute prophylactic treatment (DOPT) using the new 3HP regimen Assignment Collaborators: Government of LTBI diagnosed people (2-65 to the current standard of 9 months INH Masking: Open Label Nunavut, Government of Canada 450 NCT02689089 Primary Purpose: Prevention years) with either TST or IGRA
The correlate of risk targeted A prognostic correlate of risk (COR), based on messenger Development of new tests Interventional Allocation: Randomized Isoniazid, Rifapentine Sponsor: University Cape Town intervention study (CORTIS) ribonucleic acid (mRNA) expression signatures, which with improved performance Endpoint Classification: Collaborators: South African TB prospectively discriminates between TB cases and healthy and biomarkers Safety/Efficacy Study Vaccine Initiative, Aurum Institute, controls, has been constructed and validated. Test whether Intervention Model: Single Group Centre for the AIDS Programme fo preventive therapy (3HP) reduces the rate of incident TB Assignment Research in South Africa, University of Aged between 18 and 60, with 3200 NCT02735590 disease, compared to standard of care (active surveillance), Masking: Open Label Stellenbosch, London School of known COR and HIV status. in COR+ persons. Primary Purpose: Prevention Hygiene and Tropical Medicine, Fred Test whether COR status differentiates persons with Hutchinson Cancer Research Center cumulative prevalent or incident TB disease from persons without TB disease.
New generation IGRA in Evaluates the performance of a new ELISA based Performance of comercially Observational Observational Model: Cohort QuantiFERON TB plus in-tube test Germany, Italy, Republic Tuberculosis Network European Immunocompetent and immunocompromised individuals QuantiFERON-TB plus in-tube test to identify M.tuberculosis available immunotests Time Perspective: Prospective of Moldova, Norway, Trialsgroup immunocompromised patients (Tbnet#54) specific immune Responses as evidence of latent infection Poland, Portugal, with and without risk factors 2000 NCT02639936 with M.tuberculosis in immunosuppressed populations. Romania, Spain, United for prior exposure with M. Kingdom tuberculosis Testing for Tuberculosis in the We itend to test a cohort of HIV infected subjects for latent Programme management Observational Observational Model: Cohor IGRA, TST, chest x-ray, sputum, United Kingdom Investigator: Marc Lipman United Kingdom HIV infected TB infection in HIV infected individuals to assess the cost- Time Perspective: Prospective Sponsor: University College, London Population effectiveness of systematic TB screening and the use anti-TB antibiotics to prevent reactivation of TB. Patients attending an ambulatory clinic for HIV care 300 NCT02712671 in London, HIV, latent Tuberculosis Comparing consistency of In patients receiving long term dialysis, using new generation Performance of comercially Observational Observational Model: Cohort, Examination of LTBI by Taiwan Chin-Chung Shu QuantiFERON TB gold plus and of QuantiFERON-TB Gold Plus can have less result variability available immunotests Time Perspective: Prospective QuantiFERON TB QuantiFERON TB gold for latent in inter-experiment and serial follow up in comparing with tuberculosis in dialysis population QuantiFERON-TB gold in tube.
Patients on dialysis 200 NCT02782494
Efficacy of weekly rifapentine and This is an open-label, randomized, Phase III clinical trial to Treatment/intervention Interventional Phase 3 Weekly INH/RPT given by DOT China Sponsor: Huashan Hospital isoniazid for tuberculosis evaluate the effectiveness and tolerability of the 3RPT/INH Allocation: Randomized prevention to prevent tuberculosis compared with those who do not Endpoint Classification: receive preventive treatment among silicotic patients. Safety/Efficacy Study Intervention Model: Parallel Male adult Assignment 566 NCT02430259 Silicosis Masking: Open Label Primary Purpose: Prevention
A5300/I2003 PHOENIx Study PHOENIx is a Phase III trial in development by the ACTG Treatment Interventional Phase 3 efficacy of 6 months of daily Botswana (1) JHU Treating HIV-infected and and IMPAACT networks to assess the efficacy of 6 delamanid (novel intervention Brazil (1) other child, adolescent months of daily delamanid (novel intervention arm) arm) versus 6 months of isoniazid Haiti (1) A5300/I2003 and adult household contacts versus 6 months of isoniazid preventive therapy (control preventive therapy (control Kenya (1) http://www.impaactnetwo of MDR TB 3,452 comparison arm) in high -risk household contacts of adult comparison arm) in high -risk India (2) rk.org/studies/IMPAACT20 patients, including pre pulmonary MDR TB cases. household contacts of adult Peru (2) 03B.asp pulmonary MDR TB cases South Africa (8) -XDR TB and XDR TB, Tanzania (1) who are at high risk of Thailand (2) developing TB. Screening for Latent Tuberculosis The overall objective of this study is to assess the feasibility Programme management observational Intervention Model: Single Group Drug: BST USA Uniformed Services University of the Soldiers 1781 NCT00804713 Infection (LTBI) in US Army Recruits and potential impact of using a targeted testing approach Assignment 0.1 mcg/mL (1 dose) Battey skin Health Sciences (LTBI) and 2 interferon-gamma release assays (IGRA) to screen for Masking: Double Blind (Subject, test (BST) antigen administered Infectious Diseases Clinical Research latent tuberculosis (TB) infection (LTBI) among military Outcomes Assessor) using the Mantoux method. Program recruits. The current policy of universal application of the Primary Purpose: Screening Drug: TST Mantoux tuberculin skin test (TST) to screen for LTBI may Administer TB Skin test (TST) TB mHealth Study - Use of Cell This study will examine the impact of use of mobile phones Treatment adherence Interventional Study Type: Interventional Cell phone intervention arm: Canada University of British Columbia 350 NCT01549457 Phones to Improve Compliance in and text messaging on adherence to treatment for patients Study Design: Allocation: Upon consent, participants will be British Columbia Cancer Agency Persons initiating treatment for Patients on LTBI Treatment with latent TB infection. Half (50%) of the 350 anticipated Randomized randomly assigned to receive latent TB infection over the age study participants will receive weekly text messages Intervention Model: Single Group either 1) standard of care (9 of 18 years old, owning a inquiring on their health status in relation to their prescribed Assignment months of INH or 4 months of RIF) mobile phone or share access treatment, while the other half (50%) will not receive weekly Masking: Open Label and weekly SMS text messages via mobile phone access AND MTBVAC Study in Adults With and MTBVACtext messages at four at dose all. Medical levels: 5adherence x 10^3 CFU, will 5 bex 10^4 assessed CFU, by5 x Vaccination Interventional PhasePrimary 1b/2a, Purpose: double-blind, Health Services Participantsmobile phone meeting or 2) standard the of South Africa Aeras Personsdemonstrate of both sufficient sexes 18-50 ability 120 NCT02933281 Without Latent Tuberculosis 10^5 CFU, and 5 x 10^6 CFU. The active control is BCG (5 x randomized, BCG-controlled, inclusion/exclusion criteria will be Biofabri, S.L years old, ho have recieved a Infection in South Africa (A-050) 10^5 CFU). Participants will receive a single dose of MTBVAC dose-escalation safety and randomized within a study cohort Universidad de Zaragoza prebious BCG vaccination. IGRA or BCG revaccination administered intradermally on Study immunogenicity study. to receive a single dose of MTBVAC South African Tuberculosis Vaccine positive or negative. Day 0. or BCG revaccination administered Initiative intradermally on Study Day 0. TuBerculosis Vaccine Initiative TParticipants will be randomized within each cohort, to receive either MTBVAC (N=96) or BCG The Role of IGRA in Screening and This study aims to investigate the role of IGRA in screening Programme management Observational Part I of this study aims to Hong Kong Chinese University of Hong Kong 560 NCT02135289 Monitoring for TB During Anti TNF for latent TB in IBD patients and control subjects. In part II of Observational Model: Case investigate the role of IGRA in Patients aged 18 years or Therapy in Patients With IMID the study, patients of other immune-mediated inflammatory Control. Time Perspective: screening for latent TB in IBD older (IGRA) diseases (IMID) will also be included to investigate the role Prospective patients and control subjects. Part patients with a diagnosis of of serial interferon-gamma release assays (IGRA) for the II of this study is a prospective Crohn's disease (CD) or diagnosis of tuberculosis (TB) infection in patients with study of serial interferon-gamma ulcerative colitis (UC) for at immune-mediated inflammatory diseases (IMID) treated release assays (IGRA) for the least 3 months defined by with biologics. diagnosis of tuberculosis (TB) histology or radiology infection in patients with immune- Performance of IGRAs for TB TB-infection diagnosis based on immunological memory detection Performance of comercially Observational Observational Model: Case- Diagnosticmediated inflammatory test performance diseases study; Paris, France Assistance Publique - Hôpitaux de Persons aged > 75 years, birth 160 NCT01895582 Infection Diagnosis in Elderly can be impaired with age. New blood tests (QFTB-G and T-SPOT.TB) available immunotests only. Time 3 tests performance for active TB Paris before 1935, with suspected Tb (IGRage) specific for MTB infection have not been evaluated in those old Perspective: Prospective diagnosis in patients older than 75 disease. patients.The primary endpoint of this study is the evaluation of years-old. Concordance between the IGRAS for active TB diagnosis in patients above 75 years old.The IGRAs. Non-concordant results aim of this study is to evaluate characteristics of the two analysis concordance of IGRAs commercials tests IGRA T-spot-TB® and Quantiferon-TB-gold- in results with time of TB-infection tube® and TST in old patients with or without active Tuberculosis. biobank Primary Prophylaxis for Prevention To determine if isoniazid is effective in the prevention of Treatment Interventional Randomized Each subject in the treatment Dourados, Brazil Federal University of Mato Grosso do Inclusion Criteria:Minimum 728 NCT03028129 of TB in Prison's Populations tuberculosis in a prison population, exposed to the high endemicity Intervention Model: Parallel Assignment group will receive two oral Sul stay estimated at 24 months of the disease. supervised weekly doses of under a closed regime, without isoniazid 900 milligram for 52 active tuberculosis or previous weeks. use of rifapentine or isoniazid, without consuming alcohol at least 3 months
IGRA and Mantoux Response in The aim of this project is to analyze the potential Performance of comercially Observational Observational Model: Case-Only Primary Outcome Measures: Siena, Italy University of Siena Children and young adults 50 NCT02653404 Children With Suspected Latent or contribution of IGRA test QuantiFERON-TB Gold In Tube test available immunotests Number of patients with between 0 to 17 years Active TB Infection (TBTubercolar) (QTF-GIT, Cellestis Limited, Carnegie, Victoria, Australia) in concordance of QTF-GIT test and Contact with TB case and/or the diagnosis of tuberculosis (TB - active or latent) in TST,among children exposed to TB clinical suspect of active TB pediatric subjects (0 and 17 year)s recently exposed to [ Time Frame: up to 4 years ] infection (indicated as "contacts") or with clinical suspicion Number of patients with of active TB, and to compare the results obtained with those positivity of QTF-GIT in comparison of the TuberculinSkin Test (TST; gold standard). with TST among children with active tuberculosis disease [ Time Frame: up to 4 years ] Number of patients with a negative QTF-GIT test in comparison of TST, among non- infected children [ Time Frame: up to 4 years ]
Diagnosis of Tuberculosis in Swiss The primary objective is to improve the sensitivity of novel Development of new tests Observational Observational Model: Cohort Secreted cytokine assay for Basel, Bern, Lausanne University Children's Hospital Basel Children / adolescents < 18 190 NCT03044509 Children (CITRUS) immunodiagnostic tests for detection of TB disease in with improved performance Time Perspective: Prospective persons with LTBI, exposure to Zurich, Switzerland. years of age undergoing children.The secondary objective is to determine biomarkers and biomarkers active Tb or with active TB. evaluation for TB exposure, that discriminate children with TB infection and disease. Cytokines will be measured using a infection or disease. No healthy bead-based multiplex assay reader individuals included. (MAGPIX, Luminex Crop., Austin, USA). Evaluation of PET/MRI Using a PET/MRI (positron emission tomography/magnetic Development of new tests Interventional Intervention Model: Single Radiation with either an FDG ligand Singapore National University Hospital, 21 Years and older (Adult, 30 NCT02967666 Somatostatin Analog Tracer as a resonance imaging) with somatostatin analog tracers has the with improved performance Group Assignment (other Name: 18F-Fludeoxyglucose) Singapore Senior) with TB exposure, LTBI Novel Approach to Detecting potential to provide an imaging technique targeting and biomarkers or with or active TB. Pathology in High Risk TB-exposed subclinical granulomatous disease in those with latent DOTANOC ligand (other Name: Contacts tuberculosis (TB), allowing identification of individuals who may be 68Ga-DOTANOC) will beperformed at risk of progression to active TB. and standard uptake values (SUV) The Correlate of Risk Targeted Effective tuberculosis (TB) control requires that people who Development of new tests Observational Randomized Drug: Isoniazid: Participants in the Cape town, SA Sponsor: Ages Eligible for Study 18 Years 3200 NCT02735590 Intervention Study (CORTIS) progress from latent Mycobacterium tuberculosis (MTB) with improved performance Intervention Model: Single Group Treatment Arm will receive high University of Cape Town to 60 Years (Adult), all sexes, infection (LTBI) to TB disease are identified and treated and biomarkers Assignment dose Isoniazid - 15mg per kg body Collaborators: healthy Volunteers accepted. before they infect others. A prognostic correlate of risk weight, rounded up to the nearest South African Tuberculosis Vaccine (COR), based on messenger ribonucleic acid (mRNA) 100 mg; maximum dose 900 mg Initiative expression signatures, which prospectively discriminates with Pyridoxine supplementation Aurum Institute between TB cases and healthy controls, has been (25mg) and Rifapentine based on Centre for the AIDS Programme of constructed and validated. Based on published microarray body weight (>32kg - 50kg: 750 mg; Research in South Africa case-control datasets, the COR has 87% diagnostic sensitivity >50kg: 900 mg), given weekly as 12 University of Stellenbosch MVA85A Aerosol vs Intramuscular A Phase I Trial to Compare the Safety and Immunogenicity of Vaccine Interventional Allocation: Randomized Biological: Aerosol inhaled UK University of Oxford Ages Eligible for Study: 18 15 NCT02532036 Vaccination in Adults With Latent Candidate TB Vaccine MVA85A Administered by the Aerosol Intervention Model: Parallel MVA85A or Study Director: Helen McShane Years to 55 Years (Adult) Mycobacterium Tuberculosis (M. Inhaled Route and the Intramuscular Route in Healthy Adult Assignment intramuscular MVA85A or University of Oxford Sexes Eligible for Study: All tb) Infection Volunteers Who Are Latently Infected With Mycobacterium Masking: Participant, Care intramuscular Saline placebo or Principal Investigator: Paul Moss Accepts Healthy Volunteers: Tuberculosis Provider, Investigator, Outcomes aerosol inhaled Saline placebo University of Birmingham Yes Assessor Principal Investigator: Marc Lipman Primary Purpose: Other Royal Free Hostpital Principal Investigator: Felicity Perrin King's College Hospital NHS Trust ENhance Initiation and Retention in To evaluate a combination intervention package (CIP) Programme management Interventional Allocation: Randomized Behavioral: Combination Ethiopia Sponsor: Sexes Eligible for Study: 338 Isoniazid Preventive Therapy (IPT) designed to improve implementation of Isoniazid Preventive Intervention Model: Parallel intervention components Columbia University Care for HIV Study (ENRICH Study) Therapy (IPT) among people living with HIV (PLWH) in Assignment. The study is a two- Drug: Isoniazid Prevention Therapy Collaborator: (ENRICH) Ethiopia. arm cluster randomized trial, The experimental intervention will National Institute of Allergy and randomized at the HIV clinic be delivered to all patients in HIV Infectious Diseases (NIAID) level, which includes 10 HIV clinics randomly assigned to CIP clinics in Dire Dawa and Harari, who initiated HIV care at the CIP Ethiopia. Clinics are randomized site on or after January 1, 2013 and NCT01926379 to deliver the combination initiated IPT on or after date of intervention package (CIP) or study initiation, July 1, 2013. In HIV standard of care (SOC), with clinics assigned to SOC, usual care stratification by facility size (<80 procedures for provision of IPT will or >80 patients enrolled in HIV be delivered. care per year) Latent Tuberculosis Infection in To determine the proportion of Korean Health Care worker Programme management Observational Single Group Assignment, Masking: QFT-IT Test and other blood sampling Korea, Republic of Hanyang University, Korea, Republic of Korean Health Care Workers Using using the IGRA Open Label, Primary Purpose: - Health care workers in University Interferon Gamma Releasing Assay Screening affiliated hospital
- Adult aged 20-65 240 NCT03010111
Rifampin versus isoniazid for the A randomised clinical trial comparing 4 months of rifampin to 9 Interventional Multicentre randomised two-arm Rifampin (drug) and isoniazid (drug). Australia Benin Brazil The Research Institute of the McGill Adults (aged greater than 18 5720 ISRCTN05675547 treatment of latent tuberculosis months of isoniazid for the treatment of latent tuberculosis positive controlled open-labelled The dosage of the medication is Canada Ghana Guinea University Health Centre (Canada) years, either sex) with infection: Part 3 effectiveness infection: To compare the cumulative incidence during 28 months clinical trial (Treatment) determined according to the weight of Indonesia Korea, South documented positive tuberculin after randomisation, of confirmed active tuberculosis (TB) among the subject: Saudi Arabia skin test (TST) and prescribed Treatment/intervention all persons randomised (effectiveness, using intention to treat Isoniazid: once per day, in pill format, 9INH for LTBI, following analysis) to 4RIF and 9INH for a total daily dose of 300 mg if authoritative recommendations. subject weighs greater than or equal Ecluding amongst others PLHIV. to 42 kg, otherwise 200 mg. Total Correlation of the Precursor The purpose of the present study is to evaluate the latent form of Other (immunology, Observational NP NP Mali, West Africa Frequency of CD4 + Effector this infection, the prevalence of which worldwide exceeds that of pathogenesis, co-infection) Memory T Cells With Induration active disease. Our hypothesis is that in latent tuberculosis antigen Measured in the Tuberculin Skin specific effector memory CD4+ T cells are responsible for the generation of clinically measurable delayed type hypersensitivity Persons18 Years and older Test (TST) 32 NCT00257907 and that central memory CD4+T cells are not directly involved in (Adult, Senior), both sexes this process. We base this idea on the assumption that latent tuberculosis is a state of antigen persistence and that effector memory T cells should be maintained as long as antigen/infection is present. A Phase I Trial to Compare the TB040 is a clinical trial to investigate and compare the effects of a Interventional •Biological: Aerosol inhaled UK Safety and Immunogenicity of candidate Tuberculosis (TB) vaccine, MVA85A, administered by MVA85A Candidate TB Vaccine MVA85A the aerosol inhaled route and the intramuscular route in healthy Allocation: Randomized Other Name: MVA85A Sponsor: adult volunteers who are latently infected with Mycobacterium Administered by the Aerosol Endpoint Classification: Safety University of Oxford tuberculosis. Inhaled Route and the Treatment/intervention Study •Biological: Intramuscular 30 Intramuscular Route in Healthy Intervention Model: Parallel MVA85A Collaborator: NCT02532036 Adult Volunteers Who Are Latently Assignment Other Name: MVA85A University of Birmingham Infected With Mycobacterium Masking: Double Blind (Subject, Tuberculosis Caregiver, Investigator, •Biological: Intramuscular Saline The HALT-LTBI study: Phase IV, To assess completion rates of two different LTBI treatment Treatment/intervention Interventional UnblindedOutcomes Assessor)RCT Randomplacebo allocation to either Rifinah UK-multicentre Sponsor: University College London multi-site, unblinded, randomised regimens (daily rifampicin/isoniazid, the current UK standard (Rifampicin plus Isoniazid) or trial of prophylactic daily treatment, vs weekly rifapentine/isoniazid). The objective of the Rifapentine and Isonazid. rifampicin/isoniazid vs. weekly pilot phase would be to assess feasibility and safety. Latent tuberculosis infection 100 ISRCTN04379941 rifapentine/isoniazid for latent tuberculosis infection (LTBI)
Developing a partnership to inform UK-Brazil TB control: Investigating the efficacy of BCGTo evaluate vaccination the followingeffect of BCG latent vaccination tuberculosis after treatment. treatment of latent TB infectionTreatment/intervention Interventional Pilot trial BCG vaccine after treatment of LTBI, serial IGRAMRC Brazil Principle investigator (UK): Ibrahim Abubakar, Brazil (Sergio Arruda) ??
Next Generation Tests for Latent Tuberculosis and PredictingPrognostic Activevalue ofTuberculosis. the next generation quantiferon test andDevelopment biomarkers offor new progression tests with improved performance andObservational biomarkers Cohort IGRA (4th Gen) Biobank for substudies UK Multi-CentreNIHR, University College London Chief investigator: IbrahimAdult Abubakar contacts of pulmonary TB 2000 ??
EffectivenessThe Of impact Testing and For value And Treatmentfor money Ofof peerHard-To-Reach support to Groups improve For clinical Latent engagement Tuberculosis, in Hepatitishard-to-reach B Virus individuals And Hepatitis with Chepatitis Virus In CEngland. virus (HCV) will be assessed.Adherance Assessment and completion of completion in treatment rates forObservational a novel, short, LTBI treatment regimen.Cohort IGRA tests Funder: UK Department ofUK Health Sponsor: Public Health England Contacts, Principle Migrants investigator: and others Ibrahim at riskAbubakar of LTBI ??
Programme grant to control tuberculosis among hard to reach patients in London. (includes an LTBIAssess survey prevalence in prisons of and latent injecting TB in drug hard users) to reach groups Programme management Observational Cross sectional study IGRA UK Funder: NIHR Chief Investigator: Andrew Hayward Hard to reach groups ?? Impact, acceptability and cost-effectiveness of identifying infectious diseases amongst migrants in primary Assesscare (this prevalence includes oflatent latent TB TB screening). in migrants Programme management Observational Cohort IGRA UK Chief Investigator: Manish Pareek Migrants ??
Latent Tuberculosis Infection (LTBI) amongScreening migrant for workers latent fromTB infection third countries in migrants in Cyprus using IGRA and analysis of progression to disease followingProgramme 6 months management IPT. Observational Prospective cohort Sponsor:LTBI intervention Under negotiation Center for CommunicableCyprus Disease Control, Makarios III Hospital, Nicosia Pulmonology Clinic,Migrant Nicosia workers General Hosp. University of1000 Nicosia To be announced
The purpose of the study is to explore risk factors for TB in Norway and assess the targeting of LTBI screening and treatment 2008-2014. The population includesTo assess all persons targeting tested of LTBI with treatment IGRA OR who in Norway has been (2008 notified to 2014) to the Norwegian TB register with TB or LTBI treatment in NorwayProgramme in 2008-2014. management These data will beObservational linked to Statistics Norway Register-basedfor demographic study data, Norwegian prescription database for prescriptions and theNorway Norwegian Hospital DischargeNorwegian Database Health Association Allfor cases co-morbidities. with (NHA) an IGRA result (positive and negative) OR TB or LTBI treatment80000 ??
Assess outcome of LTBI treatment Data will include all cases prescribed with LTBI treatment in Programme management Observational Prospective cohort Norway Norwegian Institute of Public Health and reasons for non-completion. Norway in 2016. The data to be collected are to a large extent (NIPH) consistent with the LTBI Task force suggestions for monitoring and Information will soon be evaluation, with more detailed data on safety. We will use this as a LTBI cases App 700 available on the web pilot for assess the feasibility of routine monitoring of LTBI treatment outcome.
BarriersThis isto a TB qualitative screening study among immigrants run by an NGO (LHL international) aiming to identify barriersProgramme to screening management for TB. Observational Qualitative study Norway Norwegian Heart and Lung Association (LHL International) Immigrants 25 ??
EvaluationNational of LTBI screening data collection policy andin the analysis National of LTBITB Control screening Plan policy, (2016-2020). practices and results of clinical risk groups in hospitals, as partProgramme of the National management TB Control Plan 2016-2020.Evaluation Prospective Observational The Netherlands KNCV LTBI cases The National TB Control Plan will be published soon (in Dutch) and sent out for translation. Evaluation of LTBI screeing and Programme management observational The Netherlands prevention among at risk migrant Evaluation KNCV ?? populations US NIH clinical centre trial Impact of 3HP on the steady state pharmacokinetics of Treatment Interventional NCT02777229 Dolutegravir and Darunavir boosted with Cobicistat in Healthy Volunteers
NCT02777229
Treatment Interventional
Concomitant treatment with EFV-based ARV and RIF-containing TB therapy is demonstrated to be safe and effective however side-effect profile of EFV ViiV Healthcare clinical trial[1] (Phase III- overlaps with the rifampicin. This trial is designed to study safety and efficacy of NCT02178592 b study) Dolutegravir or Efavirenz administered with two NRTIs in HIV-1-infected ART- naïve adults starting WHO-recommended standard treatment for rifampicin- sensitive TB ADVANCE[2] is a USAID funded andSupport Wits Reproductive studies planned Health with and this HIV trial Institute likely to led generate trial more evidence of RIF/DTG and RIF/TAF interactions byTreatment September 2019 Interventional
Treatment Interventional
French National Institute for Health and Medical Research trial in A sub-study as a part of this trial is planned to review the pharmacokinetics of Cameroon[3] (phase III randomized DTG and EFV 400 use in TB co-infected patients controlled trial)
Improving the Detection of Active This proposal is focused upon early diagnosis, referral Operational & Observational Prospective cohort Procedure: venepuncture, UK Sponsor: Public Health England Tuberculosis in Accident and and treatment of active tuberculosis, which has two key programmatic sputum collection, xray Principle investigator: Ibrahim Emergency Departments (ACE) components: 1) ensuring optimal outcome for individuals; venepuncture, sputum collection, Abubakar 2) contributing to disease control in public health terms xray by preventing further spread. Individuals at high risk of TB 1000 NCT02512484
3 HP pharmacokinetics when given Pharmacokinetics Interventional 3 HP selfadministered therapy, with dolutegravir or efavirenz single course or on a yearly basis in high TB burden settings http://www.tbonline.info/me dia/uploads/documents/tb_c ab_meeting_report_decembe r2015_capetown_external_fi nal.pdf
ACTG 5279: Phase III Clinical Trial of Ultra-Short-Course To compare two treatments to prevent active TB in persons with HIV and latent TB Treatment Rifapentine, IsoniazidInterventional and vitamin B6Randomised. (pyridoxine) Controlledwill be provided phase while III on study. Subjects will take Rifapentine/Isoniazid plus B6 for 4 weeks or Isoniazid plus vitaminJHU B6 for 9 months For People who have HIV and Latent Tuberculosis Rifapentine/Isoniazid for the Prevention
TBTC Study 37: Shortened RPT regimen for PT Treatment Interventional Randomized, controlled RPT qd for 6 wks vs. RIF qd 4 mo vs. RPT+INH qwk TBTC Study. An Evaluation of The trial is conducted in patients diagnosed with latent Operational/treatment Phase 3 •Behavioral: Self Administered United States, China, Adherence to Latent Tuberculosis tuberculosis infection (LTBI) who are recommended for adherance Allocation: Randomized Therapy (SAT) South Africa, Spain 1) persons with a positive Infection (LTBI) Treatment With treatment. The primary objective is to evaluate adherence Interventional Endpoint Classification: Self Administered Therapy (SAT) TSTor IGRA AND one of the 12 Doses of Once Weekly to a three-month (12-dose) regimen of weekly rifapentine Safety/Efficacy Study following: close contact to Rifapentine (RPT) and Isoniazid and isoniazid (3RPT/INH) given by directly observed Intervention Model: Parallel •Behavioral: SMS reminders someone with culture (INH) Given as Self-administered therapy (DOT) compared to self-administered therapy Assignment Short Message Service (SMS) text confirmed TB, HIV infection, (SAT) Versus Directly-observed (SAT). Masking: Open Label reminders or > 2 cm2 of pulmonary Sponsor: Therapy (DOT): iAdhere. Primary Purpose: Prevention parenchymal fibrosis on chest Centers for Disease Control and 1002 NCT01582711 •Drug: isoniazid and rifapentine X-ray and no prior history of Prevention TB treatment; 2) TST or IGRA converters 3) Persons with any other clinical indication for LTBI treatment (e.g. HIV- infected close contacts to an active pulmonary TB cases)
Evaluation of LTBI management in Description of LTBI recording and reporting system and the Operational Observational The Netherlands the Netherlands (1993-2013). results of 21 years of LTBI monitoring and evaluation, focusing on trends in target groups for LTBI screening and Retrospective cohort Evaluation KNCV LTBI cases 37,729 ERJ preventive treatment (PT) regimens, including PT initiation, PT completion and PT discontinuation related to the Risk to develop TB among persons Riskoccurrence to develop of adverse TB among events persons are explored. diagnosed with LTBI in Risk factors and disease Observational The Netherlands diagnosed with LTBI in the the Netherlands. This study examines TB incidence among progression Netherland (1993-2013). persons identified with LTBI and determines risk factors associated with progression to TB among those treated and untreated. Retrospective cohort Evaluation KNCV LTBI cases ERJ
Landscaping on on-going Disease progression and risk Guideline developments for tests that better factors development predict progression from latent TB ??
Target Product Profile (TPP): Test Guide test developers as to key requirements for assays to Other (immunology, Evaluation and for Progression of Tuberculosis better predict progression from infection to active disease pathogenesis, co-infection) developmental Infection ??
Document to outline trial guideline provide guidance on key study design Disease progression and risk Guideline to evaluate tests that better predict requirements when evaluating tests that better factors development progression from latent TB predict progression from infection to active disease ??
Development of Human Nasal The investigators will carry out nasal challenge with bacterial Other (immunology, Interventional Non-Randomized The nose will be sprayed with a UK Imperial Clinical Respiratory Research Males and females aged 18 to 174 NCT02090374 Challenge Models With Microbial and viral components and allergens. In this way the nasal pathogenesis, co-infection) substance that is a single part of a Unit (ICRRU), St Mary's Hospital 60 years. Current non-smokers Constituents and Grass Pollen upper respiratory tract mucosa is challenged with stimuli of bacteria or virus, or with an for last year, maximum of 10 the immune system, causing various types of inflammation. allergen.The study employs cigs per month, with a smoking Samples will be taken by blotting the nostril surface and by noninvasive methods of sampling history of <5 pack years scraping off tiny surface samples. using absorptive strips. These strips look and feel like tissue paper, and are applied to each nostril for a period of 1 min. A few pinhead- sized tissue samples are taken from inside the nose, using a small disposable sterile plastic probe that has a tiny scoop on its end. In the nasal lining fluid and tissue samples, measurement will taken Impact of New Immunological The primary endpoint of this study is the evaluation of the theoric Diagnostic and screening Interventional Single Group Assignment The primary endpoint of this study is France Assistance Publique - Hôpitaux de Paris Diagnosis Tests of Latent Tuberculosis therapeutic impact of the use of new tests for diagnosis of LTBI in the evaluation of the theoric Before Anti TNF Therapy patients before anti TBF therapy therapeutic impact of the use of new Ages Eligible for Study: 18 tests for diagnosis of LTBI in patients Years and older (Adult, Senior) before anti TBF therapyBiological: Sexes Eligible for Study: All QFTB-G and T-SPOT.TB tests Accepts Healthy Volunteers: No 430 NCT00811343 Evaluation of an Enhanced Evaluation of an Enhanced Tuberculosis Infection Control Infection control Observational Stratified, matched, cluster- Facilities randomized to the Viet Nam and Thailand Centers for Disease Control and Health care worker; this study ? NCT02073240 Tuberculosis Infection Control Intervention in Healthcare Facilities in Vietnam and Thailand. randomized, controlled trial intervention group will receive: Prevention will be conducted at 22 Intervention in Healthcare Facilities Prevalence of latent Tuberculosis infection (LTBI) in Skills-based training addressing the United States President's Emergency hospitals, 10 in Thailand and 12 in Vietnam and Thailand (EnTIC) healthcare workers (HCWs) will be at measured at baseline, hierarchy of TB IC measures, how Plan for AIDS Relief in Vietnam and LTBI incidence will be measured among susceptible to conduct a facility TB IC /risk HCWs at 12 and 24 months. Secondary outcomes will be assessment; and development, measures at 0 (pre-intervention) 6, 12, 18, and 24 months. In implementation, and monitoring of year three, results will be analyzed and disseminate an operational TB IC plan for the facility. Audits and Feedback of performance A TB IC Surveillance and Follow-up for To follow-up latent tuberculosis infection and evaluate the § Observational Taiwan Latent Tuberculosis Infection and risk of developing active tuberculosis in patients with severe Observation of the Effect of chronic kidney disease or receiving long-term dialysis Prophylactic Latent Tuberculosis Observational Model: Cohort The patients with severe Sponsor:National Taiwan University Treatment in Patients With Severe Time Perspective: Prospective Not provided chronic kidney disease or long 500 NCT01685086 Hospital Chronic Kidney Disease or Receiving term dialysis Long-term Dialysis
Is Tuberculin Skin Testing Effective HIV infection highly increases the risk of progression of Programme management Observational United States in Screening for Latent Tuberculosis latent tuberculosis (TB) to active disease that therapy is in Patients With HIV? recommended for all PPD-positive, HIV-infected patients, regardless of age. Sensitivity of the PPD testing is, however, Observational Model: Case Sponsor: Adult patients with HIV dependent on a normal T cell function. Control T-Spot.TB test North Shore Long Island Jewish Health confirmed by standard 53 NCT00763295 Time Perspective: Prospective System methods Therefore, an accurate and reliable method for detection of latent tuberculosis in patients with HIV is urgently needed.
This prospective study will examine the utility of interferon- Determining Risk in Latent Understanding the risk factors that contribute to latent TB Development of new tests Observational Observational perspective Not provided Korea, Republic of Sponsor: National Institute of Allergy Tuberculosis developing into active TB, and whether it is possible to test with improved performance and Infectious Diseases (NIAID) for this risk. and biomarkers Healthy particpants not exposed to TB, active TB, latent 1200 NCT01571739 TB,
Improving Latent Tuberculosis (TB) Objective is to assess the sensitivity and specificity of IGRAs Performance of comercially Observational Not provided Thailand Sponsor: South East Asia Research Diagnosis in Thai Children and TST in screening for latent TB HIV-infected and HIV available immunotests Collaboration with Hawaii uninfected children in Thailand, to improve the diagnosis Collaborators: Thai children between the ages and management of latent TB. •Columbia University of 2 months and 16 years with Observational cohort, exposure to active TB adult •New York Blood Center 158 NCT00947609 prospective •HIV Netherlands Australia Thailand cases will be referred to the Research Collaboration two study sites for eligibility •Queen Sirikit National Institute of screening. Child Health Comparing the Efficacy of Two Though still an endemic area, the incidence of tuberculosis Treatment Interventional 4-month rifampin (Experimental) Taiwan Preventive Regimens for Adult (TB) in Taiwan is decreasing in recent years. Further vs. 9-month isoniazid (Active Household Contacts With Latent reduction in TB incidence, or even elimination should rely on comparator) Tuberculosis Infection treatment for LTBI. However, which is the cost-effective Adult household contact of Phase 3, RCT, parallel, open lable, Sponsor:National Taiwan University patients with newly diagnosed, screening method or what is the cost-effective regimen in 300 NCT01398618 Taiwan is still unclear. intervention Hospital culture-confirmed pulmonary tuberculosis Therefore, the investigators designed this prospective study to follow up adult household contacts with LTBI for 2 years and compare the efficacy of 9-month isoniazid and 4-month Better Identification of Latent The aim of study is to evaluate the prevalence of latent TB in Programme management Observational Answering the study Questionnaire Israel Sponsor: Tuberculosis Infection Among Israeli second generation immigrants from countries with high and blood sampling for Interferon Sheba Medical Center Second generation immigrants Young Adults by Comparison Skin incidence of tuberculosis (above 20 of 100,000) compare to gamma release assay (IGRA) from countries with high incidence of tuberculosis Tests and Interferon Gamma the control native Israelis without a family member who was Non-Randomized, Single Blind Collaborator: (above 20 of 100,000). Releasing Assays (IGRA) born in a country with high incidence of tuberculosis. Using (Investigator), Parallel Native Israelis 200 NCT02073669 study questionnaire IGRA and tuberculin skin test the Assignment Tel Aviv Lung Association investigators expect that the second generation immigrants without a family member who group will have more positive IGRA test than the control was born in a country with high native group. incidence of tuberculosis. Impact of HIV Infection on Latent HIV induced altered representation and function of Other (immunology, Observational India Sponsor: TB Among Patients With HIV-TB Co- regulatory T cell subsets (NKT and Treg cells) impair the pathogenesis, co-infection) infection protective T cell response against M.tuberculosis and Ministry of Science and Technology, disrupts LTBI, thus facilitates faster progression and India HIV+ve+LTBI HIV+ve+clinical TB development of severe forms of clinical TB in HIV-TB co- Prospective Not provided HIV-ve+clinical TB Normal 180 NCT00692809 infection. Collaborator: control
Indian Council of Medical Research
Screening for Latent Tuberculosis in The ministry of health in Israel requires all health-care Programme management Observational Israel Healthcare Workers With workers to undergo screening for latent Tuberculosis Quantiferon-Gold Assay: A Cost- infection (LTBI) prior to starting work. This is based on the Effectiveness Analysis Mantoux skin test, which is notoriously unreliable. In recent years, more specific and sensitive tests based on interferon-gamma secretion to TB antigens have come to Defined Population Sponsor: Assuta Hospital Systems Blood test for Quantiferon-GOLD Inclusion Criteria: market, and most current evidence shows that many Screening 150 NCT00449345 assay mantoux positive persons do not have LTBI. Quantiferon- Longitudinal Collaborator: Maccabi GOLD is one of these assays. In this prospective study, we will draw blood for the Quantiferon-GOLD assay in parallel to conventional testing, and perform a cost-effectiveness analysis of the cost of the investigation and treatment of LTBI in health-care workers.
Prospective Comparison of the This is a prospective cohort study of persons tested for Performance of comercially Observational Cohort Not provided USA Tuberculin Skin Test and Interferon- latent tuberculosis infection at either high risk for exposure available immunotests Prospective Gamma Release Assays in to Mycobacterium tuberculosis or high risk for progression Diagnosing Infection With to tuberculosis disease. The study will assess the relative Sponsors and Collaborators Individuals at high risk for Mycobacterium Tuberculosis and in performance and cost of three diagnostic tests for latent latent tuberculosis infection or 42647 Predicting Progression to tuberculosis infection (tuberculin skin test, QuantiFERON-TB Centers for Disease Control and at high risk for progression to NCT01622140 Tuberculosis Gold In-Tube, and T-SPOT.TB) and will examine the rates of Prevention tuberculosis positive results among the cohort. This study will also determine the risk and rate of progression to active TB disease, overall and by the results of the three tests.
Study of Latent Tuberculosis The High Resolution Scanners (HR TC) offer the possibility of Development of new tests Observational Case-Only Not provided Spain Sponsor: Only a single population is Infection (LTBI) by High Resolution detecting any lesion approximately 1 mm in diameter, so the with improved performance Prospective Germans Trias i Pujol Hospital going to be studied: the LTBI, Scanner investigators plan to use this technique to screen people and biomarkers thus people with proof to be 12 NCT00904956 already infected by M. tuberculosis (but not ill, following the Collaborator: M. tuberculosis infected but Diagnosis Standard Guidelines). CIBERES CRP-TB program demonstrating not having active disease. The Usefulness of Interferon-γ The purposes of this study Performance of comercially Observational Korea, Republic of Sponsor: Release Assays and Tuberculin Skin 1.to compare the positivity of tuberculin skin test(TST) and available immunotests Hanyang University •Approximately 2,000 patients Test for Detection of Latent QuantiFERON-TB Gold (QFT-G), and determine the level of with rheumatic diseases who Tuberculosis Infection agreement between two tests in patients with rheumatic Collaborator: examined TST or QFT-G diseases Cohort Bristol-Myers Squibb •Approximately 400 patients Not provided 2000 NCT01685905 2.to evaluate the difference in the occurrence of active TB in Retrospective with rheumatic diseases who patients who receive both QFT-G and TST compared with received TST or QFT-G before those who receive only TST for detecting of Latent using anti-TNF agents. tuberculosis infection(LTBI) who are candidates of TNF inhibitors.
A Phase I/II Trial of the The purpose of this study is to evaluate the Treatment/pharmacokinetics Non-Randomized, •Drug: Rifapentine (RPT) Not provided Sponsor: This study will enroll HIV-1- Pharmacokinetics, Tolerability, and pharmacokinetics, tolerability, and safety of once-weekly Pharmacokinetics Study, 900 mg of RPT infected and HIV-1-uninfected Safety of Once-Weekly Rifapentine doses of rifapentine (RPT) and isoniazid (INH) in HIV-1- Interventional Parallel Assignment, National Institute of Allergy and pregnant women with latent and Isoniazid in HIV-1-infected and infected and HIV-1-uninfected pregnant and postpartum Open Label •Drug: Isoniazid (INH) Infectious Diseases (NIAID) TB . Cohort 1 participants will 82 NCT02651259 HIV-1-uninfected Pregnant and women with latent tuberculosis (TB). 900 mg of INH be enrolled in their second Postpartum Women With Latent trimester. Cohort 2 Tuberculosis Infection •Dietary Supplement: Pyridoxine participants will be enrolled in (vitamin B6) their third trimester