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Latent Tuberculosis clinical trials

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NCT ID: NCT05541952 Withdrawn - Latent Tuberculosis Clinical Trials

BCG Re-vaccination for Primary Tuberculosis Prophylaxis in the Prison Population

PPT-BCG
Start date: August 17, 2020
Phase: Phase 4
Study type: Interventional

In the last decade, the incidence of tuberculosis (TB) has declined in much of the world, but has increased in Central and South America. Since 2000, the prison population in these localizations has grown by 206%, the highest increase in the world. In the same period, the reported cases of TB among the prison population (PP) increased by 269%. The extraordinarily high risk of acquiring TB within prisons creates a health and human rights crisis for PP that also undermines broader TB control efforts. Same studies identified an annual incidence of 26,000 per 100,000 for latent TB infection (through conversion of the tuberculin skin test) and of 4,000 per 100,000 for active TB among the PP in the state of Mato Grosso do Sul. In view of the combination of a high rate of infection and development of active disease and a short period of incarceration (on average 3 years), primary prophylaxis with BCG revaccination may be a cost-effective alternative associated with mass screening for control of the disease. Recently, in a phase 2 clinical trial, the BCG vaccine was shown to be 45% effective in preventing sustained IGRA conversion in adolescents in South Africa. With this study, the investigators aim to evaluate the effectiveness of BCG revaccination for primary TB prophylaxis in healthy individuals exposed to an environment of high disease transmission. This is an open-label, randomized phase IV clinical trial involving 760 individuals from three prisons in the state of Mato Grosso do Sul. Participants will be monitored for 26 months to calculate vaccination effectiveness to reduce latent tuberculosis infection as measured through sustained IGRA conversion. By carrying out this clinical trial, the researchers intend to obtain scientific evidence that can contribute to the tuberculosis control policy in Brazil.

NCT ID: NCT03783728 Withdrawn - Latent Tuberculosis Clinical Trials

Video Based Directly Observed Therapy for Latent TB

Start date: June 30, 2019
Phase:
Study type: Observational

Center for Disease Control (CDC) data reveal that after years of sustained decrease, the incidence of active tuberculosis (TB) disease in the US has plateaued. Most of the cases occur when Mycobacterium tuberculosis (Mtb) reactivates replication in people who have latent tuberculosis infection (LTBI). Only 5 to 10% of subjects with LTBI develop active TB Infection over their lifetime. Current US guidelines recommend treating everyone with LTBI to stop progression to active TB. As treatment is long, only about 45-55% of patients finish treatment overall, regardless of whether the patients are at high (>10%) or low lifetime risk of reactivation. The investigator's study aims to test the efficacy of a combined approach of first determining subjects at high risk of reactivation and then treating them with a CDC approved once a week treatment regimen, directly observed by a nurse over video (video-based Directly Observed Therapy, vDOT). Ensuring treatment of the high-risk group will eventually decrease the community active TB burden.

NCT ID: NCT03498534 Withdrawn - Diabetes Mellitus Clinical Trials

Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis

Start date: September 2012
Phase: Phase 4
Study type: Interventional

Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts. Elispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays).

NCT ID: NCT03265977 Withdrawn - Clinical trials for Tuberculosis Infection

A Phase II Study of H56:IC31 in Healthy Adolescents

A-043
Start date: June 2018
Phase: Phase 2
Study type: Interventional

This clinical trial will evaluate safety, immunogenicity, and efficacy (prevention of Mtb infection as measured by IGRA conversions) of H56:IC31 in remotely BCG vaccinated adolescents.

NCT ID: NCT02605538 Withdrawn - Cystic Fibrosis Clinical Trials

Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively

Start date: September 1, 2015
Phase: N/A
Study type: Interventional

CF patients are at risk for hepatic disease. Vaccination is recommended to all CF patients according to European consensus. The aim of the study is to vaccinate as many patients as possible and to follow up whether immunization has been complete.

NCT ID: NCT00788320 Withdrawn - Tuberculosis Clinical Trials

Vitamin D in Active Tuberculosis (TB) Study

Start date: October 2008
Phase: N/A
Study type: Interventional

Tuberculosis is a disease caused by a bacterium (a germ) that can cause illness in any organ of the body, but most frequently causes disease of the lungs. TB is short for tuberculosis. Treating TB requires several months (usually 6 months) of treatment, with the first 2 months being intensive treatment with usually four medicines. Treatment is needed to keep the infection from getting worse and to prevent death from TB. Vitamin D is a hormone present in the human body to manage levels of some essential electrolytes such as calcium and phosphate. Vitamin D is important for bone formation and prevention of bone breakdown (osteoporosis) as the investigators age. There is also new evidence that links vitamin D to function of our immune system as well. Even though our bodies can make vitamin D and can also obtain vitamin D from our diet, most adults, especially patients with tuberculosis have low vitamin D levels (are vitamin D deficient) that need to be corrected. Full correction of low vitamin D levels requires 6 weeks or more of weekly vitamin D supplements. There are several benefits to correcting vitamin D deficiency (better bone health, better balance of calcium and phosphate), but it is not known whether correcting vitamin D deficiency will lead to a better immune response to tuberculosis. Preliminary data does suggest that vitamin D increases the levels of an antimicrobial molecule (cathelicidin LL-37) in the body, possibly leading to better immunity against tuberculosis. The primary objective of this pilot study is to assess the relationship of vitamin D levels in patients with active pulmonary tuberculosis to levels of LL-37 cathelicidin in sputum and whole blood. The results of this study are needed in preparation for larger studies that will evaluate the role of vitamin D supplementation as adjunctive therapy to standard medical treatment for tuberculosis.

NCT ID: NCT00558480 Withdrawn - Clinical trials for Latent Tuberculosis Infection

Vitamin A Supplementation for Modulation of Mycobacterium Tuberculosis Immune Responses in Latent Tuberculosis

Start date: July 2009
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00424684 Withdrawn - Clinical trials for Chronic Liver Disease

Comparison of the Quantiferon®-TB GOLD (in Tube) Assay With Tuberculin Skin Testing for Detecting Latent Tuberculosis Infection in Patients With Chronic Liver Disease Being Evaluated for or Awaiting Liver Transplantation

Start date: January 2007
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant recipients. Management of tuberculosis in this setting is challenging due to the complexity of diagnosis and the potential toxicity of anti-TB therapy, especially in liver transplant candidates and recipients. Although the tuberculin skin test (TST) is recommended for screening of latent tuberculosis infection (LTBI) in all candidates for liver transplantation, the performance of the TST in this setting is less than optimal, due to a lack of specificity (false-positive results due to interaction with BCG vaccine and other mycobacterial infections), and a lack of sensitivity in a population that is relatively immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved for the diagnosis of LTBI. QFT-G detects the release of interferon-gamma (IFN-γ) by sensitized white cells after incubation of whole blood with TB antigens. QFT-G is expected to be more specific than TST. However, there are no studies defining the performance of QFT-G in a population of patients on a waiting list for liver transplantation. We plan to estimate the usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage liver disease. We hypothesize that the QFT-G test will correlate better with the risk of LTBI. This study advances research on the prevention of a serious bacterial infection that can have devastating consequences in the post-transplant setting. The new diagnostic strategy may more accurately determine the presence of LTBI, thereby allowing appropriate therapy.