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Summary and Purpose To follow-up latent tuberculosis infection and evaluate the risk of developing active tuberculosis in patients with severe chronic kidney disease or receiving long-term dialysis Field/research Study type Intervention Study location Sponsor, collaborator and investigator HIV infection highly increases the risk of progression of latent tuberculosis (TB) to active Diagnostic disease that therapy is recommended for all PPD-positive, HIV-infected patients, regardless of age. Sensitivity of the PPD testing is, however, dependent on a normal T cell function. Observational Therefore, an accurate and reliable method for detection of latent tuberculosis in patients with HIV is urgently needed. Disease progression and risk factors Observational Observational Model: Cohort Time Perspective: Prospective Not provided Taiwan Observational Model: Case Control Time Perspective: Prospective T-Spot.TB test United States Observational perspective Not provided Objective is to assess the sensitivity and specificity of IGRAs and TST in screening for latent TB Diagnostic HIV-infected and HIV uninfected children in Thailand, to improve the diagnosis and management of latent TB. Though still an endemic area, the incidence of tuberculosis (TB) in Taiwan is decreasing in Treatment recent years. Further reduction in TB incidence, or even elimination should rely on treatment for LTBI. However, which is the cost-effective screening method or what is the cost-effective regimen in Taiwan is still unclear. Diagnostic HIV induced altered representation and function of regulatory T cell subsets (NKT and Treg cells) impair the protective T cell response against M.tuberculosis and disrupts LTBI, thus facilitates faster progression and development of severe forms of clinical TB in HIV-TB coinfection. Disease progression and risk factors Status Available source of information (website, trial identity code) Observational cohort, prospective Thailand Sponsor:National Taiwan University Hospital The patients with severe chronic kidney disease or long term dialysis 500 Recruiting NCT01685086 Sponsor: North Shore Long Island Jewish Health System Adult patients with HIV confirmed by standard methods 53 Reruitment completed NCT00763295 Healthy particpants not exposed to TB, active TB, latent TB, 1200 Terminated NCT01571739 Thai children between the ages of 2 months and 16 years with exposure to active TB adult cases will be referred to the two study sites for eligibility screening. 158 Completed NCT00947609 Adult household contact of patients with newly diagnosed, cultureconfirmed pulmonary tuberculosis 300 nown status, not recru NCT01398618 200 Not yet recruiting NCT02073669 180 Recruiting Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Sponsor: South East Asia Research Collaboration with Hawaii Collaborators: •Columbia University •New York Blood Center •HIV Netherlands Australia Thailand Research Collaboration •Queen Sirikit National Institute of Child Health Interventional Intervention Phase 3, RCT, parallel, open lable, intervention Non-Randomized, Single Blind (Investigator), Parallel Assignment Taiwan Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA) Sponsor:National Taiwan University Hospital Sponsor: Sheba Medical Center Israel Collaborator: Tel Aviv Lung Association Observational Prospective Not provided India Ministry of Science and Technology, India In recent years, more specific and sensitive tests based on interferon-gamma secretion to TB antigens have come to market, and most current evidence shows that many mantoux positive persons do not have LTBI. Quantiferon-GOLD is one of these assays. Observational This is a prospective cohort study of persons tested for latent tuberculosis infection at either Diagnostic and disease high risk for exposure to Mycobacterium tuberculosis or high risk for progression to progression tuberculosis disease. The study will assess the relative performance and cost of three diagnostic tests 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. HIV+ve+LTBI HIV+ve+clinical TB HIVve+clinical TB Normal control NCT00692809 Indian Council of Medical Research Operational 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. Second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000). Native Israelis without a family member who was born in a country with high incidence of tuberculosis. Sponsor: Collaborator: The High Resolution Scanners (HR TC) offer the possibility of detecting any lesion approximately 1 mm in diameter, so the investigators plan to use this technique to screen people already infected by M. tuberculosis (but not ill, following the Diagnosis Standard Guidelines). Sample size 4-month rifampin (Experimental) vs. 9-month isoniazid (Active comparator) 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 rifampicin). The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group. Korea, Republic of Not provided Observational The ministry of health in Israel requires all health-care workers to undergo screening for latent Tuberculosis infection (LTBI) prior to starting work. This is based on the Mantoux skin test, which is notoriously unreliable. Study population/condition Disease progression and risk factors Observational This prospective study will examine the utility of interferon-gamma (IFN-γ) based assay, TSPOT TB for detection of TB in HIV infected individuals Understanding the risk factors that contribute to latent TB developing into active TB, and whether it is possible to test for this risk. Study design Defined Population Screening Longitudinal Cohort Prospective Blood test for Quantiferon-GOLD assay Israel Sponsor: Assuta Hospital Systems USA Sponsors and Collaborators Centers for Disease Control and Prevention Case-Only Prospective Observational 150 Recruiting 42647 Recruiting NCT00449345 Not provided Observational Diagnostic Inclusion Criteria: Collaborator: Maccabi Not provided Sponsor: Germans Trias i Pujol Hospital Spain Collaborator: CIBERES CRP-TB program Individuals at high risk for latent tuberculosis infection or at high risk for progression to tuberculosis Only a single population is going to be studied: the LTBI, thus people with proof to be M. tuberculosis infected but demonstrating not having active disease. NCT01622140 12 Recruiting NCT00904956 Information from TF members The purposes of this study Diagnostic 1.to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G), and determine the level of agreement between two tests in patients with rheumatic diseases 2.to evaluate the difference in the occurrence of active TB in patients who receive both QFTG and TST compared with those who receive only TST for detecting of Latent tuberculosis infection(LTBI) who are candidates of TNF inhibitors. Sponsor: Hanyang University Observational The purpose of this study is to evaluate the pharmacokinetics, tolerability, and safety of once- Treatment/intervention weekly doses of rifapentine (RPT) and isoniazid (INH) in HIV-1-infected and HIV-1-uninfected pregnant and postpartum women with latent tuberculosis (TB). Cohort Retrospective Non-Randomized, Pharmacokinetics Study, Parallel Assignment, Open Label To compare the effectiveness of linking the Quantiferon-gold in-tube test (QGIT) with routine Diagnostic CD4 testing to the routine use of the tuberculin skin test (TST), the current standard of care for diagnosing latent tuberculosis infection (LTBI) in South Africa. The investigators hypothesize that QGIT clinics will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher proportion of patients and in a significantly faster timeframe. The costeffectiveness of linking QGIT with routine CD4 compared to routine TST will also be evaluated, Interventional Interventional Interventional Study based in Southern Ethiopia Purpose - to explore if children in contact with adults with TB have positive acute reactants such as IFN-y and other cytokine responses; if these responses discriminate between high and low risk of disease progression and whether these could be incorporated into improved diagnostic approaches. Diagnostic and disease progression The apoptosis-associated markers, including Fas ligand, Decoy-receptor 3, Lipoxin, and Biomarkers and Disease prostaglandin E2, are discriminative in patients with active TB from those with LTBI and thus progression might predict the potential of being active TB from LTBI. To compare the serum apoptosisassociated markers between patients with active TB and patients with LTBI To evaluate the efficiency of apoptosis-associated markers to differentiate potential of active TB from LTBI Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic 2000 Recruiting NCT01685905 This study will enroll HIV-1-infected and HIV-1-uninfected pregnant women with latent TB . Cohort 1 participants will be enrolled in their second trimester. Cohort 2 participants will be enrolled in their third trimester 82 Not yet recruiting NCT02651259 TB contacts and refugees in San Diego who are prescribed 3HP for LTBI treatment by their physician will be randomly assigned to be monitored for adherence via either VDOT or inperson DOT 310 Not yet recruiting NCT02641106 3000 Recruiting NCT02119130 8200 Recruiting NCT02276755 322 Recruiting NCT02208427 500 Not yet recruiting Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) •Drug: Isoniazid (INH) 900 mg of INH Video Directly Observed Therapy, Person DOT (Control) •Approximately 2,000 patients with rheumatic diseases who examined TST or QFT-G •Approximately 400 patients with rheumatic diseases who received TST or QFT-G before using anti-TNF agents. Not provided In- Sponsor: University of California, San Diego USA Sponsor: Johns Hopkins University Device: QGIT South Africa Collaborators: National Institute of Allergy and Infectious Diseases (NIAID) The goal of this clinical trial is to investigate the preventive role of vitamin D supplementation Treatment/intervention in school age children in a high transmission setting. The investigators hypothesis is that (1) vitamin D supplementation will reduce rate of acquisition of LTBI, (2) vitamin D supplementation will lead to greater reductions in active TB incidence, and (3) children with the lowest vitamin D status at baseline will gain most from the intervention. The incidence of TB in Taiwan has gradually declined in recent 10 years. In order to maintain Treatment/intervention the trend of decreasing in incidence, preventive therapy for LTBI become more and more important. However, which is the best preventive regimen for LTBI is still unknown. Therefore, we conduct the prospective randomized multicenter studies to compare the treatment completion rate of two regimens in Taiwan. The first regimen is daily isoniazid for 9 months. The second is weekly rifapentine plus high-dose isoniazid for 3 months. •Drug: Rifapentine (RPT) 900 mg of RPT •Dietary Supplement: Pyridoxine (vitamin B6) 25 mg to 100 mg of pyridoxine, based on the current local, national, or international dosing guidelines. Interventional A novel mHealth application that allows patients to make and send videos of each Operational medication dose ingested that are watched by healthcare providers via a HIPAA-compliant website to remotely monitor LTBI treatment adherence (Video DOT [VDOT]) has been developed. This study will determine whether monitoring patients with VDOT achieves higher treatment completion rates and greater patient acceptability at lower cost than clinicbased in-person DOT. Korea, Republic of Not provided Collaborator: Bristol-Myers Squibb Interventional Observational Phase 3, Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention •Other: Placebo Placebo group will receive placebo (Tishcon, USA) bi-weekly. Phase 3 Allocation: Randomized Rifapentine and Isoniazid for 3 months versus Endpoint Classification: Isoniazid for 9 months Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention Observational Model: Defined Population Time Perspective: Longitudinal Observational Model: Case Control Time Perspective: Prospective University of Witwatersrand, South Africa •Dietary Supplement: cholecalciferol (vitamin D) 14000 IU vitamin D3 weekly Experimental group will receive vitamin D supplement (Tishcon, USA). Not provided Taiwan Not provided Ethiopia Taiwan Healthy children ages between 6 and 13 years, enrolled in participating schools Not currently TB infected. Sponsor: National Taiwan University Hospital Sponsor: Liverpool School of Tropical Medicine Collaborator: Thrasher Research Fund Not provided Observational Sponsor: Harvard School of Public Health National Taiwan University Hospital Children with suspicion of TB attending health centres will also be investigated 1.Patients with tuberculosis: microbiology or pathology proven tuberculosis infection 2.Patients with latent tuberculosis infection are defined by interferongamma release assay 3.Patients without tuberculosis and latent tuberculosis are defi=ed by negative findings in above-mentioned results NCT00456469 400 Recruiting 30 Recruiting NCT01676155 •Biological: Aerosol inhaled MVA85A Other Name: MVA85A TB040 is a clinical trial to investigate and compare the effects of a candidate Tuberculosis (TB) vaccine, MVA85A, administered by the aerosol inhaled route and the intramuscular route in healthy adult volunteers who are latently infected with Mycobacterium tuberculosis. Treatment/intervention Interventional Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) •Biological: Intramuscular MVA85A Other Name: MVA85A •Biological: Intramuscular Saline placebo Other Name: Saline •Biological: Aerosol inhaled Saline placebo Other Name: Saline UK Sponsor: University of Oxford Collaborator: University of Birmingham NCT02532036 The objective of this study is to assess the efficacy of the two current TB (tuberculosis) blood Diagnostic and disease tests (Interferon Gamma Release Assays (IGRA)) compared with the standard skin test progression (Mantoux Tuberculin Skin Test (TST)), for predicting active tuberculosis among those at increased risk of TB. Those at increased risk are defined as either newly arrived immigrants or people who have been in contact with TB cases. The study will also provide information on the cost effectiveness of different testing strategies, such as the two step testing approach recommended by NICE. Observational Model: Cohort Time Perspective: Prospective Not provided Sponsor: Public Health England Collaborators: United Kingdom Observational Imperial College London Queen Mary University of London Those who are close contacts of active tuberculosis cases or those who have are new entrants to the UK from high incidence countries (>40/100000). 10000 Active, not recruiting NCT01162265 Household contacts exposed to patients with sputum smear positive tuberculosis that are: 1. Above the age of 5 years 2. HIV negative 3. Tested positive on both the tuberculin skin test and the QuantiFERON®-TB Gold In-Tube® test 145 completed ISRCTN15705625 Child between 2 and 17 years, who have had contact with tuberculosis 24 Recruiting NCT02581579 The study will enrol participants with LTBI 250 Recruiting NCT02225158 Persons with clinical indication for latent tuberculosis infection (LTBI) treatment. 80 Closed: follow-up continuing ACTRN12613000599 774 4000 Recruiting NCT01547884 350 Active, not recruiting NCT01549457 3000 Active, not recruiting NCT01404312 150 Recruiting NCT01212003 University College, London Brunel University Isoniazid is an antibacterial drug used to treat active TB infections. This drug is also commonly used to prevent active TB developing in people who have come into contact with an infected person. The aim of this study is understand the way that isoniazid preventative treatment (IPT) affects the body in people with latent TB, and if it can increase immunity to TB in general. Treatment Radomised controlled trial nested within a cohort study (Treatment) Interventional This is a double-blind, masked, compared with placebo clinical trial in pediatric population in Disease progression and risk contact with tuberculosis with or without tuberculosis infection. This trial aims to study the factors effect of the probiotic Nyaditum resae® at the level of specific Treg memory cells eight weeks after the first administration, and the global tolerability of the treatment. Interventional Nyaditum resae® is a preparation in the form of capsules 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. To study how the immune system of people with latent tuberculosis infection (LTBI) acts to Disease progression and risk prevent development of active TB. Also, to study how helminth infection might affect this factors immune response. An exploratory objective is to evaluate if there are subsets of subjects within the LTBI group (irrespective of helminth infection status) who have stable pool of long lasting antigen-specific IL-2 only producing CD4+ central memory T cells and changes to this pool after receiving LTBI treatment. Household contacts that were eligible for the study were randomized to receive either isoniazid preventive therapy (IPT) and monthly visits or monthly visits only. Household contacts in the IPT arm were offered self-administerd isoniazid (5mg/kg to a max of 300mg) plus pyridoxine 25mg daily for six months. Phase 1 Allocation: Dietary Supplement: Nyaditum resae ® 10e5 of Randomized, Endpoint heat-killed Mycobacterium manresensis Classification: Safety/Efficacy Other: Placebo Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention University of Birmingham College of Health Sciences, Makerere University Uganda Sponsor: Manresana de Micobacteriologia, SL Spain Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) United States Observational Study Design: Time Perspective: Prospective The aim of this study is to perform a multimodal comparison of 3-month courses of weekly isoniazid and rifapentine (3HR) with 9 months of daily isoniazid (9H) for latent tuberculosis infection, using a variety of indices: Operational A 12 dose course of weekly isoniazid (900mg) and rifapentine (900mg) tablets. Other (immunology, pathogenesis, co-infection) Time Perspective: CrossSectional not provided Interventional Sponsor: United States Observational This study will examine the impact of use of mobile phones and text messaging on adherence Operational to treatment for patients with latent TB infection. Half (50%) of the 350 anticipated study participants will receive weekly text messages inquiring on their health status in relation to their prescribed treatment, while the other half (50%) will not receive weekly text messages at all. Medical adherence will be assessed by monthly blood-work, clinic visits and by interviewing patients at each of these visits. Sponsor: Hospital Melbourne Health Australia Interventional a. Cost-benefit b. Patient satisfaction c. Adherence to prescribed therapy Researchers want to study people with latent tuberculosis (TB) who may or may not be infected with filariasis. This study will look at the way that people with latent TB fight infection with these worms. Randomised controlled trial Parallel Phase: Phase 4 Phase 0 Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research Other: Cell phone text messages Participants in the intervention arm will receive weekly text messages from the TB control clinic asking how they are. National Institute of Allergy and Infectious Diseases (NIAID) Treatment/intervention To provide better training for infectious disease staff members at the National Institutes of Operational/programmatic Health Clinical Center in Washington, D.C., researchers are interested in actively recruiting and basic science individuals with TB for research and treatment studies. Objectives: •To provide staff at the National Institutes of Health Clinical 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. Interventional Phase 3 Allocation: Dietary Supplement: Pyridoxine (Vitamin B6) Randomized, Intervention Drug: Isoniazid (INH) Model: Parallel Assignment, Drug: Rifapentine (RPT) Masking: Open Label, Primary Purpose: Prevention - Individuals between 18 and 65 years of age who have latent TB and may or may not have filarial infection. Sponsor: University of British Columbia Collaborator: Canada British Columbia Cancer Agency 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. HIV-infected people have an increased risk of developing active tuberculosis (TB). The standard course of treatment for TB is 6 to 9 months of isoniazid (INH). A shorter course of treatment may be as effective and potentially increase treatment adherence. This study will compare the safety and 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. Eligibility: Inclusion Criteria: Are initiating treatment for latent TB infection Sponsor: United States, Botswana, Brazil, Haiti, National Institute of Allergy and Infectious Diseases Kenya, Malawi, Peru, (NIAID) South Africa, Thailand, Zimbabwe Time Perspective: Prospective HIV + persons with latent TB Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) United States Observational To assess completion rates of two different LTBI treatment regimens (daily rifampicin/isoniazid, the current UK standard treatment, vs weekly rifapentine/isoniazid). The objective of the pilot phase would be to assess feasibility and safety. Ibrahim Abubakar Steven Graham (Austrailia) Phillipe LoBue (USA) To assess the efficacy of preventive therapy (levofloxacin versus placebo) in all contacts (adults and children) The lack of evidence on MDR-TB preventive therapy makes it difficult to develop evidence-based guidelines, leading to 'recommendations' based on opinion only. If proven to be efficacious, safe, cost-effective, and acceptable to families and the NTP, we anticipate that this trial will inform global guidelines for post-exposure preventive therapy in child and adolescent contacts of MDR-TB. Dick menzies Ibrahim Abu bakar (UK) The RD1 based ex vivo enzyme linked immunospot assay versus Tuberculin PPD RT 23 SSI for mantoux testing Observational Treatment/intervention Interventional Observational Interventional The current standard regimen is 9 months of Isoniazid (9INH). This regimen has excellent Treatment/intervention efficacy if taken regularly, but its effectiveness is substantially reduced by poor compliance. Based on some evidence in treatment of LTBI, and extrapolating from extensive experience with treatment of active TB, it is believed that 4RIF has similar efficacy as 9INH. Therefore, the investigators are initiating the first multi-site international randomized trial that will compare the effectiveness of 4RIF and 9INH in preventing active tuberculosis. Once children are exposed and infected they are at very high risk to develop active TB Treatment/intervention which can be lethal if not detected and treated promptly. This makes it very important to detect TB infection as soon as possible, and treat this while it is still latent or dormant. Current therapy for latent TB infection is 9 months of Isoniazid; this is very effective if taken properly but because treatment is so long many children do not finish this. Four months of Rifampin is a recommended alternative. It is hypothesized that among children at high risk for development of active TB, intolerance/adverse events will not be worse (non-inferiority), among those randomized to 4RIF compared to those randomized to 9INH. In 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. Currently available blood tests for latent tuberculosis infection (LTBI) identify people Diagnostic and disease who have been previously infected with M. tuberculosis. Whilst they are sensitive and progression specific, they cannot be used to monitor the effectiveness of treatment for LTBI. New blood tests ("fourth generation Quantiferon tests") have not yet been evaluated in clinical practice, so their usefulness in identifying people at highest risk of TB disease and monitoring treatment is unknown. Interventional Interventional Interventional Latent tuberculosis infection Randomised controlled trial Parallel Renal failure and iatrogenic immunosuppression associated with solid organ transplantation or TNF alpha blockade in rheumatoid arthritis multiple: UK, NHMRC, Vietnam National Treatment Program Vietnam Multi centre phase III, double blind RCT 24 weeks of daily levofloxacin against 24 weeks of daily placebo Observational Model: Cohort Time Perspective: Prospective not provided Phase 3 Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention •Behavioral: Self Administered Therapy (SAT) Self Administered Therapy (SAT) Phase 3 Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Isoniazid versus Rifampin Phase 3 Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Drug: Isoniazid verusu Rifampin Single Group Assignment Open Label Primary Purpose: Diagnostic Procedure: blood test, not yet marketed, no trade name blood test using the new TB diagnostic test South Africa 10 sites across the United States •Behavioral: SMS reminders Short Message Service (SMS) text reminders •Drug: isoniazid and rifapentine 100 Completed ISRCTN04379941 On going EudraCT Number: 2005-005664-88 Sponsor: University of Oxford UK-multicentre Six months of daily oral levofloxacin Interventional Operational and diagnostic and disease progression This is a prospective cohort study of persons tested for latent tuberculosis infection at either high risk for exposure to Mycobacterium tuberculosis or high risk for progression to tuberculosis disease. The study will assess the relative performance and cost of three diagnostic tests 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. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who Operational are recommended for treatment. The primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to self-administered therapy (SAT). Sponsor: University College London UK-multicentre Treatment/intervention Phillipe LoBue (USA) Dick menzies Random allocation to either Rifinah (Rifampicin plus Isoniazid) or Rifapentine and Isonazid. Interventional To validate the use of the RD1 based Exvivo IFNy ELISpot in the immunodiagnosis of Diagnostic biomarkers and tuberculosis in iatrogenically immunosuppressed populations by calculation of positive and Disease progression negative predictive values for the assay and for a comparator: the tuberculin based mantoux test. To investigate potential immune correlates of latency and active disease in tuberculosis and identify potential markers of prognosis and disease progression in tuberculosis. Steven Graham (Austrailia) Unblinded RCT Treatment/intervention United States, China, South Africa, Spain Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Korea, Republic of, Saudi Arabia Household contacts (adults, adolescents, and children down to 3 kg) of individuals with MDR-TB Joint Global Health Trials Scheme of the Department for Child <5 years who is household International Development (UK), Wellcome Trust, contact of an enrolled adult MDR-TB Medical Research Council, South African Medical case Research Council Tuberculosis Epidemiologic Studies Consortium II (TBESC II) Sponsor: Centers for Disease Control and Prevention ponsor: McGill University Collaborator: Canadian Institutes of Health Research (CIHR) Principal Investigator: Dr. Dick Menzies High risk individuals for latent TB, including children and immunocompromised persons. 1) persons with a positive TSTor IGRA AND one of the following: close contact to someone with culture confirmed TB, HIV infection, or > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of 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) 2006 Recruiting 1556 Completed 42647 Recruiting ACTRN12600021542 6 ISRCTN92634082 Steven Graham (Austrailia) Steven Graham (Austrailia) Phillipe LoBue (USA) NCT01622140 1002 completed 5720 Active, not recruiting NCT01582711 Phillipe LoBue (USA) Dick menzies NCT00931736 Sponsor: McGill University Collaborator: Canadian Institutes of Health Research (CIHR) Australia, Benin, Brazil, Canada, Ghana, Information provided by (Responsible Party): Guinea, Indonesia Dr. Dick Menzies, McGill University Children (age <18) with documented positive TST (or in the absence of TST, a positive QFT or T-Spot) and prescribed preventive treatment for LTBI 822 Completed NCT00170209 Dick menzies 2000 Recruiting NCT02512939 Ibrahim Abu bakar (UK) Sponsor: Public Health England UK Collaborator: University College, London Adult contacts of smearpositive pulmonary TB patients and patients with active TB. Hajj pilgrims: Individuals arranging travel to Saudi Arabia for the Hajj through participating tour operators. Ibrahim Abu bakar (UK) This proposal is focused upon early diagnosis, referral and treatment of active tuberculosis, which has two key components: 1) ensuring optimal outcome for individuals; 2) contributing to disease control in public health terms by preventing further spread. Operational & programmatic Prospective cohort Observational Operational & programmatic Cohort Procedure: venepuncture, sputum collection, xray venepuncture, sputum collection, xray Latent TB testing and treatment programmes Observational Ibrahim Abu bakar (UK) Treatment of latent TB in primary care compared to secondary care Ibrahim Abu bakar (UK) Predictive value of the two commercial IGRAs compared to TST Operational & programmatic Observational Prognostic To evaluate the effect of BCG vaccination after treatment of latent TB infection Cohort Treatment UK Multiple: UK, Netherlands, Sweden, Italy, Romania and Bulgaria A cluster randomised controlled Treatment of LTBI in primary care trial Observationa Ibrahim Abu bakar (UK) Sponsor: Public Health England Principle investigator: Ibrahim Abubakar Pilot trial UK Two commercial IGRAs (T-Spot TB and Quantiferon, TST) Biobank for substudies Prognostic value of the next generation quantiferon test and biomarkers for progression Ibrahim Abu bakar (UK) Diagnostic and disease progression Assess prevalence of latent TB in hard to reach groups Observational Cohort Operational & programmatic BCG, serial IGRA IGRA (4th Gen) Biobank for substudies UK Multi-Centre IGRA tests Assess prevalence of latent TB in migrants Screening for latent TB infection in migrants using IGRA and analysis of progression to disease Operational & programmatic following 6 months IPT. Brita Askeland Winje (Norway) Brita Askeland Winje (Norway) Brita Askeland Winje (Norway) Gerard de Vries Gerard de Vries Observational The purpose of the study is to explore risk factors for TB in Norway and assess the targeting Operational & programmatic of LTBI screening and treatment 2008-2014. The population includes all persons tested with IGRA OR who has been notified to the Norwegian TB register with TB or LTBI treatment in Norway in 2008-2014. These data will be linked to Statistics Norway for demographic data, Norwegian prescription database for prescriptions and the Norwegian Hospital Discharge Database for co-morbidities. Data will include all cases prescribed with LTBI treatment in Norway in 2016. The data to be Operational & programmatic collected are to a large extent consistent with the LTBI Task force suggestions for monitoring and evaluation, with more detailed data on safety. We will use this as a pilot for assess the feasibility of routine monitoring of LTBI treatment outcome. This is a qualitative study among immigrants run by an NGO (LHL international) aiming to identify barriers to screening for TB. Operational & programmatic Lessons learned from the different pilots will be used to improve intervention within the specific target population. Quantitative results from the pilots on uptake of LTBI screening and PT will be used as input to assess the long term impact in terms of costs and cases averted with different LTBI strategies. Operational Description of LTBI recording and reporting system and the results of 21 years of LTBI monitoring and evaluation, focusing on trends in target groups for LTBI screening and preventive treatment (PT) regimens, including PT initiation, PT completion and PT discontinuation related to the occurrence of adverse events are explored. Operational Ibrahim Abu bakar (UK) Migrants Ibrahim Abu bakar (UK) Contacts, Migrants 10,000 Ibrahim Abu bakar (UK) Ibrahim Abu bakar (UK) NIHR, University College London Ibrahim Abubakar Chief investigator: Adult contacts of pulmonary TB 2,000 Ibrahim Abu bakar (UK) Contacts, Migrants and others at risk of LTBI IGRA Ibrahim Abu bakar (UK) Funder: NIHR Chief Investigator: Andrew Hayward UK Hard to reach groups Ibrahim Abu bakar (UK) Migrants Ibrahim Abu bakar (UK) Chief Investigator: Manish Pareek Observational Dr Constantia Voniatis (Cyprus) Barts Charity Chief investigator: Heinke Kunts Co-aaplicant: Ibrahim Abubakar 2016-2018 Funder: UK Department of Health Sponsor: Public Health England Principle investigator: Ibrahim Abubakar Operational & programmatic Ibrahim Abu bakar (UK) Various UK Cross sectional study Ibrahim Abu bakar (UK) MRC Principle investigator (UK): Ibrahim Abubakar, Brazil (Sergio Arruda) Observational Ibrahim Abu bakar (UK) NCT02512484 Chief UK Observational Ibrahim Abu bakar (UK) Not yet recruiting 2013-2016 Brazil Cohort The impact and value for money of peer support to improve clinical engagement in hard-to- Operational & reach individuals with hepatitis C virus (HCV) will be assessed. Assessment of completion programmatic rates for a novel, short, LTBI treatment regimen. EU Third Health Programme investigator : Ibrahim Abu bakar 1000 Chief investigator: Ibrahim Abubakar Interventional Ibrahim Abu bakar (UK) Individuals at high risk of TB Observational Observational Observational Cohort IGRA UK Prospective cohort LTBI intervention Cyprus Norway Register-based study Prospective cohort Norway Qualitative study Observational Multiple pilot studies Prospective cohort Observational Retrospective cohort Norway LTBI intervention The Netherlands Evaluation The Netherlands Sponsor: Under negotiation Center for Communicable Disease Control, Makarios III Hospital, Nicosia Pulmonology Clinic, Nicosia General Hosp. University of Nicosia Norwegian Health Association (NHA) Norwegian Institute of Public Health (NIPH) Norwegian Heart and Lung Association (LHL International) ZonMw (The Netherlands Organization for Health Research and Development) – Govt institution. KNCV, RIVM, Municipal Health Services, Universities KNCV Migrant workers All cases with an IGRA result (positive and negative) OR TB or LTBI treatment LTBI cases 1000 Planning stage 80000 Active App 700 25 Immigrants • Regular immigrants • Asylum seekers • Somali and Eritrean population LTBI cases Active Active On going (2015-2019) 37,729 Manuscript excepted in ERJ To be announced Information will soon be available on the web http://www.zonmw. nl/nl/projecten/proj ect-detail/tbendpointtuberculosiselimination-in-thenetherlands-throughdisease-preventionoptimalization/same Dr Constantia Voniatis (Cyprus) Brita Askeland Winje (Norway) Brita Askeland Winje (Norway) Brita Askeland Winje (Norway) Gerard de Vries Gerard de Vries Risk to develop TB among persons diagnosed with LTBI in the Netherlands. This study examines TB incidence among persons identified with LTBI and determines risk factors associated with progression to TB among those treated and untreated. Risk factors and disease progression Gerard de Vries Study is based on a previous evaluation report (2016-2010) with more than 60,000 contacts screened (45,000 for LTBI) and 3,050 LTBI cases identified. Observational Retrospective cohort Evaluation The Netherlands KNCV LTBI cases Observational Retrospective cohort Evaluation The Netherlands KNCV LTBI cases Manuscript in preparation Gerard de Vries Manuscript in preparation Gerard de Vries Operational Gerard de Vries >60,000 contacts screened National data collection and analysis of LTBI screening policy, practices and results of clinical Programmatic risk groups in hospitals, as part of the National TB Control Plan 2016-2020. Gerard de Vries Evaluation Assessing predicitive value of IGRA and to understand the contributing risk factors towards progression of disease. Gerard de Vries Prospective Evaluation The Netherlands KNCV LTBI cases Retrospective cohort Evaluation The Netherlands KNCV LTBI cases 2016-2020 The National TB Control Plan will be published soon (in Dutch) and sent out for translation. Gerard de Vries Diagnostic and disease progression Observational 4000 Planned Gerard de Vries