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NCT05022862
The purpose of this study is to evaluate a novel and scalable intervention that combines Video Directly Observed Therapy (vDOT) and financial incentives to promote completion of treatment for latent tuberculosis. Adult participants who are initiating treatment for latent tuberculosis will be recruited from the Baltimore City Health Department. The primary hypothesis is that the incentive intervention will increase the percentage of participants that complete the treatment for latent tuberculosis above the completion rates of participants receiving usual care.
NCT06033807
The goal of this observational study is to investigate the proportion of Mycobacterium tuberculosis (MTB) infection in school contacts of active tuberculosis (ATB) patients. The main questions it aims to answer are: * the proportion of MTB infection among school contacts of ATB patients * risk factors related to tuberculosis (TB) infection * health economic evaluation of screening strategy
NCT06221735
Introduction: The large reservoir of tuberculosis infections is a key driver of sustained tuberculosis (TB) incidence. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. The Cy-TB skin test and STANDARD F TB-Feron FIA (TB-Feron) fluorescent immunoassay are two newly developed TB infection tests, which could offer quality and cost advantages over other commercially available TB infection tests, especially the standard TST test. Both tests have a higher sensitivity and specificity than the currently most used tuberculin skin test. The proposed study aims to evaluate the performance of these two tests for the diagnosis of TB infection, compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay. Methods and analysis: This diagnostic accuracy study will employ a cross-sectional, observational design that aims to assess the accuracy of the Cy-TB and TB-Feron tests for diagnosing TB infection, using the QFT-Plus assay as the reference standard. The sensitivity and specificity will be reported. Three different cohorts of study participants will be recruited: Adults with microbiologically-confirmed pulmonary TB (n=100); Household contacts\* of people with TB (n=200) and negative controls\*\* (n=50). All participants will be examined with Cy-TB, TB-Feron, and QFT-Plus. \*Household contacts: of a person with TB are defined as members who live under the same roof as the person with pulmonary tuberculosis (PTB) or who meet the following conditions: * Sleeping under the same roof or sharing a kitchen space as PTB-affected persons at least one night/week for three months before the person was diagnosed with PTB * Staying under the same roof with PTB-affected persons for at least one hour/day and continuously five days/week for three months before the person was diagnosed with PTB * Negative controls are defined as people with a negative QFT-Plus result in the past year and likely to have no or very low rates of TB exposure history.
NCT05746611
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only
NCT04188041
This study explores primary care team members' knowledge, attitudinal, and skill gaps related to latent tuberculosis infection (LTBI) testing and treatment. The gaps identified will inform the design of a survey and telementoring educational program (tuberculosis (TB) infection ECHO course). The EMR data query will further explore the reach of the expansion for community healthcare outcomes (ECHO) model. The hypothesis for this study is that the TB infection ECHO course will be feasible, will have a significant impact on primary care provider participants' learning and performance related to LTBI testing and treatment in their primary care practices, and will increase the number of LTBI tests and treatment prescribed in primary care.
NCT05756582
This study is a cross-sectional study that examines the prevalence of Latent Tuberculosis Infection \[LTBI\], defined as individuals infected with Mycobacterium tuberculosis with no clinical evidence of disease, and the possible risk factors of LTBI in a large cohort of health care workers (HCWs) and students.
NCT04331262
Introduction: childhood tuberculosis continues to be a major public health problem, despite the fact that the visibility of the epidemic in this population group has increased, studies are still lacking that can resolve the gaps that persist. Objective: To design, implement and evaluate an integrated care strategy for children under five years old household contacts of patients with smear positive pulmonary tuberculosis in Medellín and the Metropolitan Area. Methodology: quasi-experimental study, in which around 300 children household contacts of patients with smear positive pulmonary tuberculosis from Medellín and the Metropolitan Area will be evaluated, who will be recruited in a period of one year. A subgroup of these children, estimated at 85, who require treatment for latent tuberculosis, will be offered to receive treatment for latent tuberculosis under a integrated care strategy that includes some modifications to the currently standardized scheme in Colombia, with rifampicin treatment daily oral route for four months, follow-up under the project scheme with the availability of a nurse, general practitioner, specialists, care by professionals from other disciplines such as social work, psychology, and nutritionist, and the provision of incentives (transport and food assistance). This strategy will be compared with isoniazid treatment according to the standardized scheme in the country, which was received by a cohort of children between 2015 and 2018. The study has the CIB Research Ethics Committee approval. Expected results: this project is expected to contribute with greater local evidence of integrated care strategies that allow greater compliance with treatment for latent tuberculosis in children, so that there is a real impact in the control of childhood tuberculosis and in the reduction of tuberculosis reservoirs in order to achieve the goals proposed by the World Health Organization's End TB Strategy.
NCT00804713
The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk recruits without affecting the identification of higher-risk recruits. The secondary hypothesis is that many discordant results between the TST and IGRA may be explained by cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.
NCT02880982
The investigators will conduct a n=5,400 Phase 3, double-blind, individually randomised placebo-controlled clinical trial of 5 years' duration in primary schools in City of Cape Town Metropolitan Municipality, Western Cape Province, Republic of South Africa. The primary objective of the trial is to determine whether a weekly oral dose of 0.25 mg (10,000 IU) vitamin D3, administered for three years, reduces risk of acquisition of latent tuberculosis infection (LTBI) in Cape Town primary schoolchildren. Statistical analysis will be performed on an intention-to-treat basis to compare acquisition of LTBI in intervention vs. control arms during three-year follow-up. The primary analysis will be logistic regression with presence/absence of LTBI at follow-up as the outcome, adjusted for a random effect of school of attendance.
NCT02090374
The investigators propose the development of a range of nasal spray challenge models to study the way the nose can respond to different types of nasal challenge that elicit different forms of inflammation. The investigators will carry out nasal challenge with bacterial and viral components and allergens. In this way the nasal upper respiratory tract mucosa is challenged with stimuli of the immune system, causing various types of inflammation. Samples will be taken by blotting the nostril surface and by scraping off tiny surface samples. The nose will be sprayed with a substance that is a single part of a bacteria or virus, or with an allergen. The material delivered by nasal spray is of high purity and is sterile, containing no live bacteria or viruses. The nasal spray substance contains molecular patterns that are recognised as foreign by the immune system, and at the right dose should stimulate the immune system, causing mild nasal inflammation. The study employs noninvasive methods of sampling 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 of a range of molecules and cells that protect against infections and help the immune response. By spraying the nose with a challenge agent in this manner, the nasal immune response can be assessed, which can help us better understand how the human immune system cells and molecules respond to bacteria and viruses. In the future, this may allow the testing of new drugs and vaccines, by seeing if they decrease or stop the inflammation after the nasal challenge.
NCT01571739
Background: \- Tuberculosis (TB) is a leading cause of death worldwide. Those who are exposed to the TB bacteria but have not become sick are said to have latent TB. Many people with latent TB will not get sick from it, but some people will develop active TB and become sick. Much is known about how to treat and diagnose active TB, but little is known about the best way to treat latent TB. Researchers also want to know more about the risk that latent TB will develop into active TB, and whether it is possible to test for this risk. Objectives: \- To test possible methods of determining a person s risk for developing active TB. Eligibility: \- Individuals between 20 and 60 years of age who (1) have active TB, (2) were exposed to someone with active TB in the past 9 months, or (3) have not been exposed to TB. Design: * Participants will be separated into groups based on their exposure to TB. * Healthy participants who were not exposed to TB will answer questions about their medical history. They will also provide blood and urine samples. * Participants who have active TB will have a physical exam and medical history. They will provide blood, urine, and sputum samples, and will have a chest x-ray. They will be treated with the standard of care for active TB. Some participants with active TB may have additional tests as part of this study. * Participants who were exposed to TB and have latent TB will have a physical exam and medical history. They will provide blood, urine, and sputum samples, and will have a chest x-ray. They will be asked to return for five more clinic visits over the next 12 months to repeat these tests. They may also have additional chest imaging studies depending on the study needs. * Some of the exposed participants may have been exposed to drug-resistant TB. These participants will receive the drug isoniazid to take on a regular schedule to help prevent the latent TB from becoming active TB.
NCT02225158
Background: Tuberculosis (TB) is a severe disease and a major cause of death in many people worldwide. It is caused by a bacteria that enters through the lungs and can spread elsewhere in the body. People with latent TB have the bacteria that lie dormant but can become active and cause disease. These people are offered treatment to prevent development of active TB. Worldwide, a lot of people with LTBI also have a parasitic worm called a helminth that can stay in the gut or the blood. These parasites can affect the immune system and cause diseases like TB to become worse. Researchers want to see how helminth infection makes it harder for people to fight TB infection. Objectives: \- To study how the immune system of people with latent tuberculosis infection (LTBI) acts to prevent development of active TB. Also, to study how helminth infection might affect this immune response. Eligibility: * Adults age 18 70 with LTBI as defined by an approved blood test called QuantiFERON TB Gold. * No evidence of infections like Hepatitis or HIV * Pregnant subjects and subjects taking medications that suppress the immune system are not eligible. * Have not received prior treatment for LTBI. Participants might be still eligible if prior treatment for active TB has been received Design: Screening phase: \- Participants will be screened with medical history, physical exam, and blood tests for other infections/conditions which might affect the immune system. They will have testing for active TB i.e. blood testing as well as testing of their spit, scans and X-rays. Baseline phase: * Only eligible participants will be entered into the study. * Participants will have interviews, medical history, and physical exam. * Blood will be drawn from an arm vein for testing. * Participants will collect stool samples at home for 3 days in a row to test for helminth infection.. * Participants may have apheresis. Blood cells are removed by needle. They pass through a separator machine which returns everything but the cells back to the participant. * Participants may have procedures at the start and end of the study that let researchers look into the lungs and collect cells. Study phase, about 2 years: * All participants will be offered treatment for LTBI which lasts 6-9 months. * Participants being treated for LTBI will have about 11 study visits. They will visit monthly for 9 months while on treatment, then 6 and 12 months after treatment. * Participants not eligible/refusing treatment for LTBI will be made aware of active TB, then have 3 other visits, about 6, 12, and 24 months after the baseline visit. * Participants who have helminth infection will receive appropriate treatment. * All participants will have blood drawn at each visit.
NCT02454738
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.
NCT00558480
In populations with high prevalence of latent tuberculosis infection (LTBI), malnutrition (PEM) may influence incident rates of TB. PEM and specific micronutrient deficiencies compromise cell mediated immunity (CMI) and increase susceptibility to, or severity of infections. Vitamin A supplementation significantly reduces all-cause child mortality. The mechanism of the benefits of supplementation on clinical outcomes is largely unknown, but is likely to be related to an influence on the immune system. Vitamin A supplementation promotes lymphogenesis and induces a higher proportion of CD4 naïve T-cells in children. Most cases of LTBI that progress to active disease are vitamin A deficient. Vitamin A deficiency is common in most TB endemic countries. At the MRC, 32% of TBCC contacts were vitamin A deficient. Hypothesis: The investigators plan to test the hypotheses: that supplementation with vitamin A will affect the magnitude and quality of immune responses to mycobacterial antigens and progression to clinical disease.
NCT01875952
The purpose of this study is to determine of once identified to the subjects infected with human immunodeficiency virus (positive VIH), to diagnose latent Tuberculosis, and to treat her with isoniazid for six months, measuring the production of Interferon range pre and posttreatment, to evaluate this way the result of the treatment on the immune response
NCT00463086
The purpose of this study is to evaluate whether isoniazid can safely (and further) reduce the risk of tuberculosis in HIV infected people receiving HAART.
NCT00692809
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 co-infection.