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Tuberculosis, Pulmonary clinical trials

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NCT ID: NCT04490746 Not yet recruiting - Tuberculosis Clinical Trials

Identifcation of Biomarkers for Active Pulmonary Tuberculosis

Start date: October 1, 2020
Phase:
Study type: Observational

This experiment is designed to analyze the metabolites in body fluids from patients with active tuberculosis and latent tuberculosis infection also with health volunteer, then combine the metabolic product features with clinical characteristics, to develop a kind of metabolites targets to evaluate the progress in tuberculosis, thus provide a basis for further utilization of humoral metabolites in the diagnosis of tuberculosis.

NCT ID: NCT04485156 Not yet recruiting - Clinical trials for Tuberculosis, Pulmonary

Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)

Hi-DoRi-3
Start date: September 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effectiveness and safety of the regimen including high dose rifampicin for individualized duration (3 months after Culture Conversion) for the treatment of drug-sensitive pulmonary tuberculosis.

NCT ID: NCT04434976 Completed - Clinical trials for Tuberculosis; Pulmonary, Confirmed, Unspecified Means

Delayed Diagnosis of Bacteriologically Positive Pulmonary Tuberculosis and Relative Optimized Suggestions in China

Start date: September 8, 2019
Phase:
Study type: Observational

The purpose of the study is to collect health-seeking pathways, sociodemographic characteristics and symptoms of 400 newly diagnosed patients with bacteriologically confirmed pulmonary tuberculosis(TB).

NCT ID: NCT04433195 Active, not recruiting - Clinical trials for Pulmonary Tuberculosis Confirmation by Culture

Xpert MTB/RIF Test in the Diagnosis of Pulmonary Tuberculosis

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

Currently in Taiwan, most clinicians use sputum smear and culture for the diagnosis of pulmonary tuberculosis (TB) and apply nucleic acid amplification (NAA) test in a selected manner. In 2013, the World Health Organization issued conditional recommendation that Xpert MTB/RIF may be used rather than conventional microscopy and culture as the initial diagnostic test in all adults suspected of having TB. The newly published Taiwan guidelines for TB diagnosis and treatment has recommended NAA test, together with smear and culture, as the initial diagnostic test in individuals suspected of having TB. The investigators conduct a prospective study to investigate the use of Xpert MTB/RIF as the initial diagnostic test of pulmonary TB under a pragmatic trial design.

NCT ID: NCT04342598 Completed - Clinical trials for Multi-drug Resistant Tuberculosis

Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India

Start date: January 27, 2020
Phase:
Study type: Observational

India has the highest incidence of and mortality from multi-drug resistant tuberculosis (MDR-TB) globally. Vitamin D status may be an important determinant of MDR-TB infection and treatment outcomes; however, observational evidence is insufficient to support its use as an adjunct therapy or prophylaxis. Using a case-control design, this study will evaluate the relationship between vitamin D status and active MDR-TB disease among adult outpatient pulmonary MDR-TB cases, household contact controls, and matched controls from the general population (non-household controls) in Mumbai, India. This study will also evaluate the cross-sectional association between vitamin D status and TB infection among household contact controls and non-household controls, and collect formative data in preparation for future randomized controlled trials of vitamin D in MDR-TB prevention and treatment in India.

NCT ID: NCT04260477 Active, not recruiting - Tuberculosis Clinical Trials

Novel Triple-dose Tuberculosis Retreatment Regimen

Tri-Do-Re
Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).

NCT ID: NCT04241809 Completed - Clinical trials for Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without Culture

Bioaerosol Sampling in Suspected Pulmonary Tuberculosis

Start date: May 15, 2020
Phase:
Study type: Observational

Tuberculosis (TB) is transmitted in bioaerosols containing Mycobacterium tuberculosis (Mtb). Mtb-containing bioaerosols are likely related to host infectiousness and central to ongoing TB transmission. No routine diagnostic assay exists to measure Mtb in bioaerosols. Furthermore, published studies of Mtb in bioaerosol samples, have been limited to individuals with sputum-positive pulmonary TB. Currently TB diagnosis is based on clinical symptoms and sputum laboratory findings. However, approximately half of all patients commencing TB treatment are sputum negative resulting in a high proportion of presumptive treatments. We therefore propose to use a sensitive sampling protocol to investigate the prevalence of Mtb-containing bioaerosols in both sputum-positive and sputum-negative TB suspects.

NCT ID: NCT04236349 Recruiting - Clinical trials for Pulmonary Tuberculosis

Tuberculosis Cohort in the North of Paris

Start date: May 1, 2018
Phase:
Study type: Observational [Patient Registry]

Tuberculosis (TB) is the leading cause of death from infectious disease in the world, just behind HIV / AIDS. Since 2005, the department of Seine Saint Denis, the poorest of France with difficult socio-economic conditions, has the highest incidence rate in metropolitan France, higher than that of Paris. In 2012, the rate of reporting was 10 times higher among people born abroad compared to those born in France, with the highest rates found among people born in sub-Saharan Africa and Asia. It is proposed to establish for the first time in France a cohort of patients with TB disease to better understand the characteristics of patients with adverse treatment outcomes and propose solutions to achieve better control of TB. This study would recruit 200 patients per year for 5 years associated with 5 years of follow-up for a total duration of the study which would be 10 years. Given the economic stakes induced by such a study, a pilot feasibility study will be carried out initially. This smaller cohort over a shorter inclusion and follow-up period will make it possible to assess the feasibility of the large-scale cohort (princeps cohort) and to propose possible improvements to the protocol or questionnaire if problems arise in the future after achievement of this pilot study.

NCT ID: NCT04232618 Recruiting - Tuberculosis Clinical Trials

Point-of-care Triage Test for Active Tuberculosis

TriageTB
Start date: November 5, 2020
Phase:
Study type: Observational [Patient Registry]

Background: Tuberculosis (TB) is a bacterial lung infection leaving 3.6 million people undiagnosed each year. Thirty percent of infected people do not receive treatment due to failure to receive diagnostic testing or being lost to follow-up between testing and availability of results. Objective: To refine and field-validate a point-of-care (POC) finger stick blood test for use worldwide to triage for active TB. Eligibility: Persons aged 12 - 70 years with symptoms suggestive of TB disease Study design: Participants will be screened with: Medical history Physical exam HIV test, diabetes screening Blood (finger stick and venous), sputum and urine collection Chest X-ray TB positive participants will receive treatment from the National TB Program at Community Health Centres and clinics.

NCT ID: NCT04207112 Completed - Clinical trials for Multi-drug Resistant Tuberculosis

Economic Evaluation of New MDR TB Regimens

PRACTECAL-EE
Start date: October 20, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The current treatment regimen for MDR-TB has poor outcomes and costs of treating MDR-TB are greater than treating drug susceptible TB, both in terms of health service and patient-incurred costs. Urgent action is needed to Identify short, effective and tolerable treatments for people with MDR-TB. The PRACTECAL economic evaluation sub-study (PRACTECAL-EE) will take place alongside the TB PRACTECAL trial, aiming to assess the costs to patients and providers of such regimens and to estimate the cost-effectiveness and poverty impact of an introduction of new MDR-TB regimens in the three countries participating in the main study.