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Tuberculosis clinical trials

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NCT ID: NCT06403943 Recruiting - Tuberculosis Clinical Trials

Efficacy Safety BaiDiZiYin ShenQiYiFei Adjunctive Treatments Pulmonary Tuberculosis

Start date: May 29, 2023
Phase: Phase 4
Study type: Interventional

This study is designed to further strengthen the clinical application evidence of BaidiZiyin Pill and ShenqiYifei Pill in the treatment of tuberculosis. To be included in the initial treatment of pulmonary tuberculosis patients, on the basis of standardized Western medicine treatment, BaidiZiyin Pills and ShenqiYifei Pills will be used to evaluate the clinical efficacy and safety of their products. 1. Evaluate the improvement of symptoms in the adjuvant treatment of newly treated pulmonary tuberculosis with BaidiZiyin Pill and ShenqiYifei Pill. 2. Explore the sputum negative conversion time and sputum negative conversion rate of BaidiZiyin Pill and ShenqiYifei Pill as adjunctive treatments for newly treated pulmonary tuberculosis. 3. Explore the protective effects of BaidiZiyin Pill and ShenqiYifei Pill on adverse reactions caused by chemotherapy.

NCT ID: NCT06403800 Recruiting - Tuberculosis Clinical Trials

Silicosis and Silicotuberculosis Among Small Scale Gemstone Miners in Northern Tanzania

SilicoTB
Start date: March 11, 2024
Phase:
Study type: Observational

Artisanal, small-scale mining (ASM) is a large and essential component of the world's economy. Despite attendant risks, there is little research into risks to the health of artisanal miners. The tanzanite gemstone is mined exclusively in Northern Tanzania, in deep shafts using ASM techniques. There is concerning evidence that the burden of silicosis and tuberculosis (TB) amongst miners is high. In addition to miners' personal risks, there is concern that a high rate of silicotuberculosis may hamper community control of TB. Our primary aim is to measure the rate of silicosis progression among tanzanite miners. Our secondary aims include measuring the prevalence of TB among miners, describing TB transmission patterns in miners and the community, and assessing rates of 'catastrophic' economic loss amongst miners. To do this, we propose two studies. First, we will establish a prospective cohort of 410 small scale tanzanite miners and record symptoms, respiratory function including spirometry, chest radiography, and prevalence of TB and HIV infection over an 18-month period. Second, we will utilize an ongoing community-based TB screening program to perform a cross-sectional survey of TB prevalence among miners and community members. To assess TB transmission, we will collect epidemiological data and perform whole genome sequencing (WGS) on positive Mycobacterium tuberculosis culture samples. Given the lack of research and large global ASM workforce, 1 million of whom are in Tanzania, the results of this study will assist in the development and introduction of interventions to reduce the risks to respiratory health of artisanal mining in Tanzania and elsewhere; and provide ample scope for future work.

NCT ID: NCT06381375 Recruiting - Clinical trials for Drug-drug Interaction

Drug-drug Interactions With Anti-tuberculous Drugs

Start date: April 30, 2024
Phase:
Study type: Observational

This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients.

NCT ID: NCT06354257 Recruiting - Tuberculosis Clinical Trials

A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age

Start date: April 5, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used.

NCT ID: NCT06347939 Recruiting - Lung Cancer Clinical Trials

Mediastinal EBUS Cryobiopsy Study In Sweden

MECRIS
Start date: April 1, 2024
Phase:
Study type: Observational

This study is a prospective observational non-randomized clinical trial where all the participitants undergo the same procedure and every participitant's samples are compared to each other. The investigators conduct EBUS TBNA and EBUS TBMCB on all the study participants.The cryobiopsy samples are numbered to evaluate the number of biopsies needed to reach a definite diagnosis and to assess the added value of every sample taken from the same participitant. Every participitant's own samples are compared to each other and added value of EBUS TBMCB is defined as the difference in diagnostic yield between the EBUS TBNA alone and the combination of EBUS TBNA with EBUS TBMCB. Diagnostic yield is defined as the efficacy of the investigation module in reaching a definite diagnosis (percentage of cases with a definite diagnosis). Follow up four weeks after the procedure to assess the risk for postoperative complications.

NCT ID: NCT06305104 Recruiting - Tuberculosis Clinical Trials

Clinical Trial to Explore the Skin Test Dosage of EEC in People Aged 18 to 65 Years Old and the Safety and Preliminary Efficacy in People Aged 3 to 75 Years Old.

Start date: July 18, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, blind, positive-controlled study to explore the skin test dosage of recombinant mycobacterium tuberculosis fusion protein ( EEC) in the population aged 18 to 65 years old , and to further evaluate the safety and preliminary efficacy of EEC in the population aged 3 to 75 years old. In the first stage,180 healthy subjects, 140 tuberculosis(TB)subjects and 40 non-TB subjects with lung diseases aged 18 to 65 years old are divided into different groups through a randomized, blind methods. Every group carry out a low-dose (2.5μg/ml) or high-dose (5μg/ml) study, with 180 subjects in each dose group .Every subject injects intradermally EEC and EC randomly in both arms of the same person. Evaluate the consistency of assay results of EEC, EC and Interferon-Gamma Release Assay(IGRA).Evaluate the sensitivity, specificity and consistency of assay results of EEC, EC and IGRA in healthy people, TB patients and non-TB patients with lung diseases, and determine the optimal dose of EEC for clinical auxiliary diagnosis of tuberculosis. In the second stage, 60 healthy subjects and TB subjects aged 3-17 years and 66-75 years old are divided into different groups through a randomized, open, single-arm method with the target dose. Evaluate the safety, tolerance and preliminary efficacy of target dose of EEC in healthy people and TB patients aged 3 to 17 years old and 66 to 75 years old.

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: NCT06246851 Recruiting - Tuberculosis Clinical Trials

BCG Revaccination Study in Diabetic and Non-Diabetic Adults

Start date: February 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to: 1. explore whether investigators can make BCG more effective by giving it in a different way. For this, aerosol inhaled BCG will be compared against the conventional BCG injection. 2. explore if there are differences in response to re-vaccination in healthy volunteers with and without Type 2 Diabetes. It will involve 36 previously BCG-vaccinated participants. Bronchoscopies will be performed 14 days post-challenge to measure BCG recovered from bronchial samples. Blood tests will be taken to look at potential immunological markers of immunity.

NCT ID: NCT06224036 Recruiting - Clinical trials for Drug-resistant Tuberculosis

Clinical Study of JDB0131 Benzenesulfonate Tablets in Patients With Drug-sensitive Pulmonary Tuberculosis

Start date: October 31, 2023
Phase: Phase 2
Study type: Interventional

A randomized, open, drug controlled design of experiments was used to evaluate the early bactericidal activity, safety, tolerance and pharmacokinetic characteristics of JDB0131 benzenesulfonate tablet taken orally by drug sensitive pulmonary tuberculosis patients. Five groups are proposed to be set up in this test (JDB0131 benzenesulfonate 100mg BID, JDB0131 benzenesulfonate 200mg QD, JDB0131 benzenesulfonate 200mg BID, anti tuberculosis drug fixed dose composite dosage QD is determined according to the weight of the study participants, and delamanid 100mg BID)

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.