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Latent Tuberculosis clinical trials

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NCT ID: NCT06289660 Recruiting - Clinical trials for Tuberculosis Infection

Multicenter Italian Cohort Study on Tuberculosis in Pediatric Age

Start date: December 22, 2022
Phase:
Study type: Observational

According to the WHO report of 2021, approximately 10 million new cases were reported in 2020, of which 1 million occurred in the pediatric population. However, epidemiological data available on tuberculosis (TB) in pediatric age are extremely limited due to diagnostic challenges in this patient category. Furthermore, children are almost never included in national surveillance systems due to the lack of connections between individual pediatricians, pediatric hospitals, and national surveillance programs. It is therefore reasonable to assume that the disease may be significantly underestimated both in Italy and worldwide.

NCT ID: NCT06221488 Recruiting - Tuberculosis Clinical Trials

Testing Health Workers At Risk to Advance Our Understanding of TB Infection

THWART-TB
Start date: January 15, 2024
Phase:
Study type: Observational

It has been estimated that 1.7 billion people have tuberculosis (TB) infection; yet current tests are unable to predict which people are at highest risk of developing TB disease, which can be life-threatening. THWART-TB is a prospective longitudinal cohort study of health workers (HWs) in Cape Town, South Africa, where our preliminary data reveals HWs have a high annual TB infection risk (34%). This cohort, who will undergo frequent serial evaluation (every 3 months) with a combination of novel assays never previously evaluated together, presents a unique opportunity to evaluate immune responses at the time of initial infection and to characterize the dynamic profile of these immune responses over time in a high-risk population. The knowledge generated will improve our understanding of TB infection and help to identify which people exposed to TB may remain at risk, enabling us to better target preventive strategies.

NCT ID: NCT06033807 Recruiting - Tuberculosis Clinical Trials

Active Screening of Latent Tuberculosis Infection in School Contacts of Active Tuberculosis Patients

Start date: September 1, 2023
Phase:
Study type: Observational [Patient Registry]

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

NCT ID: NCT06022146 Recruiting - Tuberculosis Clinical Trials

TB YOUTH - TB sYstemic Management Using One-month, Ultra-short TPT Regimen for scHool Contacts

TB-YOUTH
Start date: September 1, 2023
Phase: Phase 3
Study type: Interventional

This is a prospective, multi-center, open-label, cluster randomized controlled clinical trial conducted in school settings to estimate the non-inferiority effect of 1H3P3 compared with 3HR.

NCT ID: NCT05899179 Recruiting - Clinical trials for Latent Tuberculosis Infection

Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above

Start date: August 3, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other lung diseases who met the inclusion criteria of this study. Blood supply specific gamma-interferon (T-SPOT) detection was performed first. Then, EC and Purified Protein derivation of tuberculin (TB-PPD) skin tests were performed on both arms, and the recorded results were observed. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.

NCT ID: NCT05847491 Recruiting - Tuberculosis Clinical Trials

Latent Tuberculosis in Healthcare Workers - the Reality of a Portuguese Tertiary Hospital

Start date: September 1, 2022
Phase:
Study type: Observational

Prospective, descriptive study to assess latent tuberculosis infection (LTBI) among healthcare worker (HCW) in a tertiary hospital in a low-risk area.

NCT ID: NCT05766267 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Short-course Regimens for the Treatment of Pulmonary Tuberculosis

CRUSH-TB
Start date: November 21, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether one or two 17-week regimens of tuberculosis treatment bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z)-- (BMZ) plus either Rifabutin (Rb) or Delamanid (D or DLM) are as effective as a standard six-month regimen for treatment of pulmonary tuberculosis (TB). All three regimens are administered daily, seven days each week. The first 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus rifabutin (Rb) (BMZRB) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and Rifabutin (Rb) (2 BMZRb/2 BMRb, Arm 1) The Second 17-week regimen is 2 months of bedaquiline (B or BDQ), moxifloxacin (M), pyrazinamide (Z), (BMZ) plus delamanid (D or DLM); (BMZD) followed by 2 months of bedaquiline (B or BDQ), moxifloxacin (M) and delamanid (D or DLM) (2 BMZD/2 BMD, Arm 2) The standard 26-week treatment control regimen which is two months of isoniazid, rifampin, ethambutol, and pyrazinamide (2HRZE) followed by four months of isoniazid and rifampin (4HR); (2HRZE/4HR, Arm 3) Target enrollment is 288 male and female participants (96/arm). participants. Participants will be followed until 78 weeks post-randomization, or until the last enrolled participant completes 52 weeks post-randomization, whichever comes first.

NCT ID: NCT05756582 Recruiting - Tuberculosis Clinical Trials

Prevalence of Latent Tuberculosis Infection in Health-care Workers and Students

CROSSWORD
Start date: November 17, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT05746611 Recruiting - Clinical trials for Latent Tuberculosis Infection

Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

Start date: April 17, 2023
Phase: Phase 4
Study type: Interventional

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

NCT ID: NCT05680415 Recruiting - Clinical trials for Latent Tuberculosis Infection

Clinical Trial of Mica

Start date: April 19, 2023
Phase: Phase 4
Study type: Interventional

This study used a randomized, open, blank control design. A total of 6800 patients over 15 years old with latent mycobacterium tuberculosis infection who met the inclusion criteria but did not meet the exclusion criteria were randomly assigned to the experimental group and the blank control group in a 1:1 ratio, with 3400 patients in each group. The experimental group was alternately injected with 1 dose of microcard every two weeks (0-2-4-6-8-10 weeks) in the left and right hip muscle deep, with a total of 6 doses. The blank control group was not injected with drugs.