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Latent Tuberculosis clinical trials

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NCT ID: NCT04453293 Recruiting - Clinical trials for Tuberculosis Infection

Immunization With BCG Vaccine to Prevent Tuberculosis Infection

TIPI
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this research is to find out if a single dose of pre-travel vaccination with BCG can lessen tuberculosis (TB) infection by producing an immune response when given to adults traveling to countries with a high burden of TB. BCG will be compared with a placebo (an inactive vaccine). BCG (Japan) is used globally but is not approved for use in the United States, therefore it is considered experimental. Participants choosing to take part in this research study, will be randomly assigned (this is like a coin flip) to BCG or placebo. 2000 eligible volunteers will be enrolled.

NCT ID: NCT04271397 Recruiting - Tuberculosis Clinical Trials

Immunological Biomarkers in Tuberculosis Management

OPTI-4TB
Start date: September 30, 2019
Phase: N/A
Study type: Interventional

Tuberculosis (TB) is the leading cause of death by infectious disease in the world, responsible for 1.6 million deaths in 2017. The treatment of active TB requires at least a 6-month combined antibiotic regimen and can cause heavy side effects. As a consequence, treatment adherence is not optimal, particularly in primary care settings. Rapid and reliable monitoring of anti-TB treatment adherence and efficacy is critical to provide adequate patient care and curb relapse episodes and acquired drug resistance. Investigators propose to evaluate the performance in terms of diagnosis accuracy and outcome prediction of four new biomarkers of active TB: 1) a double IGRA (Interferon Gamma Release Assay) including QuantiFERON-Gold Plus® and HBHA; 2) a whole blood transcriptomic analysis of mRNA (messenger Ribonucleic acid) expression of a panel of 150 genes; 3) a whole blood proteomic analysis; 4) an ex vivo immunophenotyping using flow and mass cytometry to characterize the lymphocyte populations.

NCT ID: NCT04236765 Recruiting - Clinical trials for Tuberculosis Infection

Tuberculosis In Children Visiting Friends and Relatives

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

In countries with a low incidence of Tuberculosis (TB), the incidence remains higher among the immigrant population than among the autochthonous population beyond the first years after arrival in the host country. In addition, at a pediatric level, most cases are produced in immigrant children and the children of immigrants. This persistence of a greater incidence in the immigrant population might, in part, be explained by the increase in exposure to Mycobacterium tuberculosis during trips to their country of origin to visit friends and relatives (VFRs). The objectives of the study are to estimate the risk of latent infection by M. tuberculosis (LTBI)/TB in children VFRs and the factors associated with this risk. The investigators will also study the behavior of the diagnostic tests. This project will be carried out in collaboration with 21 primary health care centers and 5 hospitals in Catalonia.

NCT ID: NCT04156568 Recruiting - Children LTBI Clinical Trials

A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children

Start date: November 1, 2018
Phase: Phase 1
Study type: Interventional

The management of latent Mycobacterium tuberculosis infection is a new priority action for the WHO End Tuberculosis (TB) Strategy. However, national guidelines on latent tuberculosis infection testing and treatment have not yet been developed in children of China. Here, we present the results from the 3-year follow-up of a study that aimed to track the development of active disease in individuals with latent tuberculosis infection, identify priority populations for latent infection management, and explore the most suitable latent infection diagnostic approach.

NCT ID: NCT04148053 Recruiting - Clinical trials for Tuberculosis Infection

Evaluation of Immune Cell Markers in Diagnosis of Tuberculosis

Start date: November 1, 2018
Phase:
Study type: Observational

Diagnosis of active and latent pulmonary tuberculosis, as well as extrapulmonary tuberculosis, is still a major challenge of TB control in China. This observational study aims to evaluate TB-antigen responsive T cell markers in the diagnosis of tuberculosis and extrapulmonary tuberculosis and try to find new prompt and cost-effective laboratory tests for active TB screening.

NCT ID: NCT03941210 Recruiting - HIV Infection Clinical Trials

Micro RNA as Prediction and/or Prognostic Markers of IRIS in TB-HIV Co-infected Patients

miRNA
Start date: March 1, 2018
Phase:
Study type: Observational

The role of miRNAs in HIV disease is yet to be completely defined. Host miRNAs target certain HIV genes, thus can affect HIV replication and participate in viral control. miRNAs can also block HIV production through disruption of Gag assembly on cell membranes. miRNA expression can characterize HIV disease phenotype, as has been shown in HIV elite controllers who have a well-defined miRNA expression profile. However, the studies of miRNA in acute infection and co-infections like tuberculosis are lacking. The investigators showed that during immune reconstitution syndrome (IRIS) in HIV/TB coinfected patients, innate immune response play a role as through NK cell degranulation, therefore testing for this could be used as a predictive marker of IRIS. One of the limitations of miRNA detection is the technique, which is time-consuming, and needs laboratories that are specialized and equipped for molecular biology techniques. In contrast, flow cytometry has been developed in routine labs and has well-standardized techniques. For the routine detection of miRNA, flow cytometry could be the best way to perform high throughput screening for clinical applications. Flow cytometry is a simple and effective way to evaluate miRNAs expression. In this project the investigators propose to evaluate, using flow cytometry, whether circulating miRNA pattern might be applicable as potential biomarkers in prediction and prognosis of IRIS in HIV/TB co-infected patients. The investigators propose to study the miRNA expression profile in a cohort of patients with a HIV infection and Tuberculosis and correlate it with their clinical evolution. As controls, the investigators propose to analyze expression of miRNAs in healthy controls as well as TB and HIV mono-infected patients. AIMS OF THE PROPOSAL 1. Identify miRNA expression profile as potential novel predictive and prognostic biomarkers for IRIS. 2. Identify the miRNA expression profile in HIV patients, in TB patients and in HIV/TB co-infected patients.

NCT ID: NCT03730181 Recruiting - Latent Tuberculosis Clinical Trials

Tuberculosis Clinical Trials Consortium Study 35

Start date: October 12, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Hypotheses: Rifapentine (given as water-dispersible monolayer and/or fixed dose combination with isoniazid) dosing in HIV-infected and uninfected children ≤ 12 years of age with latent TB infection (LTBI) or with exposure to Mycobacterium tuberculosis (M. tuberculosis) will require higher mg/kg rifapentine dosing than adults to achieve adult- exposures which are correlated with efficacy in trials of TB prevention. Investigators further hypothesize that rifapentine will be safe and well-tolerated in HIV-infected and uninfected children who require treatment for LTBI.

NCT ID: NCT03474029 Recruiting - Latent Tuberculosis Clinical Trials

Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI

ASTERoiD
Start date: August 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT03312647 Recruiting - Clinical trials for Latent Tuberculosis Infection

Adverse Drug Reactions to Anti-TB Drugs in the Treatment of Latent Tuberculosis Infection

Start date: June 19, 2017
Phase: N/A
Study type: Observational

The investigators aim to study the prevalence of adverse reactions of anti-tuberculosis (TB) drugs in latent tuberculosis infection (LTBI), and determine the risk factors of anti-TB drug-related toxicity in LTBI in Korean health care workers(HCWs).

NCT ID: NCT03220464 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT

Start date: June 20, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate ultra low dose chest computed tomography (ULDCT) for early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary tuberculosis for 1 year follow up