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NCT01212003
Background: \- Tuberculosis (TB) is an infectious disease that affects numerous people worldwide. Researchers are interested in actively recruiting individuals with TB for research and treatment studies. Objectives: \- To collect blood and other samples to study the natural history of tuberculosis. Eligibility: \- Individuals 2 years of age and older who have either active or latent tuberculosis. Design: * Latent TB patients: Participants will have a single study visit with a physical examination and medical history, and will provide blood samples for testing. * Active TB patients: Participants will have an initial visit with a physical examination and medical history, and will provide blood samples for testing. Participants will also provide sputum samples if required, and may have an optional skin punch biopsy to collect a sample of skin tissue for study. * Treatment for active TB will be provided as part of this protocol. * Active TB participants may be asked to return for study visits every 1-2 months while receiving treatment....
NCT03474029
This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care. The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm). Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment. After completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.
NCT03934931
The Options for Delivering Isoniazid-Rifapentine (3HP) for TB Prevention (3HP Options Implementation Trial) study will be a three-arm, open-label, parallel, randomized trial. This hybrid effectiveness-implementation trial will be conducted among people living with HIV infection (PLHIV) enrolled in HIV/AIDS care at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. The overall objective of this study is to identify a patient-centered delivery strategy that will facilitate acceptance and completion of a three-month (12-dose) regimen of weekly rifapentine (RPT) and isoniazid (INH) by PLHIV enrolled in routine HIV/AIDS care in a high HIV/TB burden country. The primary outcome will be acceptance and completion of 3HP. Additional objectives will be to evaluate the implementation and cost-effectiveness of each delivery strategy.
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.
NCT06408129
The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.
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.
NCT05772065
Latent Tuberculosis infection (LTBI) guidelines can be complex. LTBI-ASSIST is a web-based interactive tool to navigate US LTBI clinical practice guidelines in a patient-centered format that may guide clinical decision making around Latent TB care. The research goal is to determine the difference in reported confidence among trainees that are not experts in LTBI care. The investigators further aim to assess if access to the LTBI-ASSIST tool improves clinical decision making in a series of simulated case scenarios containing guideline-derived, multiple choice items, as well as assess the efficiency in navigating the scenarios - measured by time to complete the survey. The investigators proposed a randomized study design, in which an electronic survey/questionnaire with 4 case scenarios consisting of 14 multiple choice questions. Participants providing informed consent will be randomized to receiving access to either US Centers for Disease Control (CDC)/National Tuberculosis (TB) Controllers Association (NTCA) Guidelines or the LTBI-ASSIST online tool. Those in the experimental arm will further complete a 10 question System Usability Scale to assess usability of the LTBI-ASSIST tool. All Johns Hopkins medical trainees and residents will be eligible to participate.
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.
NCT04830462
This study will be investigating the effect of latent tuberculosis infection (LTBI) treatment on glucose tolerance and low-grade inflammation. Almost a century ago, researchers proposed that diabetes (DM) was associated with increased risk of Tuberculosis infection (TB). A more recent systematic review concluded that DM increases the relative risk for TB 3.1 times. Reversely, TB may affect the glycaemic control; TB is in many cases a chronic infection characterised by long term low-grade inflammation and weight loss, and persons with TB are known to be at risk of hyperglycaemia and DM at time of diagnosis. A latent infection with the m.tuberculosis bacteria is "silent" without symptoms. 1,7 billion have LTBI on a global scale. Event though the infected person does not experience symptoms, increased background inflammation has been shown in LTBI patients in previous studies. We also know that an increase in inflammatory markers precedes clinical development of DM, and that subclinical inflammation contributes to insulin resistance. We hypothesise that LTBI contributes to dysregulated glucose metabolism due to increased low-grade inflammation, and that treatment will reduce low-grade inflammation and improve glucose tolerance.
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.
NCT02641106
The three-month short-course treatment with isoniazid \[H\] and rifapentine \[P\] (3HP) recently recommended by the Centers for Disease Control and Prevention could dramatically increase the number of persons starting and completing treatment for latent tuberculosis infection (LTBI), but TB providers nationwide are hamstrung by the requirement that 3HP only be administered by directly observed therapy (DOT) in which patients are watched taking each medication dose in-person. We developed a novel mHealth application that allows patients to make and send videos of each medication dose ingested that are watched by healthcare providers via a HIPAA-compliant website to remotely monitor LTBI treatment adherence (Video DOT \[VDOT\]). This study will determine whether monitoring patients with VDOT achieves higher treatment completion rates and greater patient acceptability at lower cost than clinic-based in-person DOT.
NCT01622140
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.
NCT03910946
identify the prevalence of latent tuberculosis (according to new guideline ;NICE tuberculosis) among these high risk groups of children and notify ministry of health
NCT03886701
Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs.