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Tuberculosis, Pulmonary clinical trials

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NCT ID: NCT05268380 Recruiting - COVID-19 Clinical Trials

Collision of Three Global Pandemics: the Effect of Tuberculosis and HIV on the Epidemiological, Clinical, Virological and Immunological Trajectory of COVID-19 in Botswana and Namibia

Core-NB
Start date: August 1, 2022
Phase:
Study type: Observational

COVID-19 has emerged as global pandemic during the past few months, with an unprecedented impact on public health, and society more generally. Virus epidemiology is poorly understood, as are factors influencing the diverse clinical picture. To date most cases have been seen in high income countries and consequently COVID-19 diagnostics and research have mainly been set-up in these settings. Outstanding questions include an understanding of how the virus spreads and how it causes pathology. A particular gap in current knowledge is the effect of HIV and tuberculosis (TB) on the outcomes of COVID-19 disease as these two conditions impair the host immune response to other infectious disease. Understanding how these three pandemics interact is crucial. We have developed a proposal that will answer critical questions concerning COVID-19 disease epidemiology in the context of low resource countries with high burden of poverty, and in the presence of high rates of TB and HIV, namely, Namibia and Botswana. Given that there are currently few cases of COVID-19 diagnosed in both countries, the project will document how the virus spreads within susceptible populations. The development of this proposal is highly collaborative and interdisciplinary, with investigators from Namibia and Botswana working closely with colleagues in Europe. We will also work with an NGO in Namibia, Health Poverty Action, to support rapid implementation. The project includes two studies that will be conducted sequentially. The first study will follow the WHO protocol for household transmission investigations in the context of COVID-19. It will explore transmission frequency and describe the clinical spectrum of disease. Samples collected will also serve as basis for COVID-19 molecular epidemiology and host immunological response. The second study will evaluate the presentation, diagnosis and clinical characteristics of individuals presenting to sentinel health facilities in both countries. The project will have a strong laboratory strengthening component which will enhance COVID-19 laboratory and research capacity. This will include the development of skills and knowledge for diagnostic testing and COVID-19 sequencing and will build scientific and research capacity. The findings from this project will provide robust data to assist in guiding national responses to COVID-19 in both countries as well as assisting with our understanding of the pathogenesis of the virus in the context of TB and HIV, in turn providing vital information on how to deliver clinical care and how to design therapeutics and vaccines.

NCT ID: NCT05258877 Completed - Clinical trials for Tuberculosis, Pulmonary

Pharmacokinetics of Ethionamide and Ethionamide Sulfoxide in Patients Established on Treatment for Tuberculosis.

Start date: June 10, 2022
Phase:
Study type: Observational

To determine the pharmacokinetics of ethionamide (Eto) and ethionamide-sulfoxide (Eto-SO) in participants with tuberculosis (TB) when Eto is dosed under programmatic conditions.

NCT ID: NCT05236452 Recruiting - Tuberculosis Clinical Trials

Effect of Integrating Traditional Tuberculosis Care With Modern Health Care on Case Detection

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Although many interventions are implemented to increase TB case detection, decrease diagnosis delay, and avoid catastrophic costs, there are no significant changes and the end TB goal will not be achieved in 2035. Innovative intervention that considers indigenous knowledge and unique culture and religious perspectives because many people go to traditional healers and holy water for healing. Therefore, integrating traditional tuberculosis care with modern care increase case detection, decrease diagnosis delay, and avoid catastrophic costs. There is no literature clearly defining integrating traditional TB care with modern care, but for the purpose of this study, integrating traditional care with modern care is defined as the collaboration of two systems through referral linkage. TB screening and diagnosis services will be done collaboratively in traditional and modern care services. A referral linkage model will be used to detect TB cases in both traditional and modern care services. Health care providers, traditional healers, priests, pastors, and imams will participate in the integration process. TB detection or diagnosis services will be integrated through referral linkage and strengthening capacity-building strategies. Traditional care centers and modern health care services will work collaboratively to improve TB case detection, reduce care costs, and avoid diagnosis delays. The standardized operational procedure of the full interventional package is described below. There are four steps of the intervention phases. These are the preliminary phase, preparation for implementation and refinement on a small scale phase, administering the intervention, and end-line assessment of outcomes. The intervention will be providing training for traditional and modern care practitioners, patient education, TB screening, and bidirectional referral linkage. This study hypothesized that integrating traditional care with modern care at the primary care level will increase the TB case detection rate by fifteen percentage points. Integrating traditional care with modern care at the primary care level will decrease TB diagnosis delay by fifteen percentage points. Integrating traditional care with modern care at the primary care level also will decrease the cost of TB care by 15 percentages of points

NCT ID: NCT05221502 Active, not recruiting - Pulmonary TB Clinical Trials

Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB

Start date: April 12, 2022
Phase: Phase 2
Study type: Interventional

This trial will assess the safety and efficacy of OPC-167832 combined with Delamanid and Bedaquiline in subjects with DS-TB administered for 4 months compared to rifampin, isoniazid, ethambutol, pyrazinamide (RHEZ) administered for 6 months

NCT ID: NCT05215990 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis

Start date: January 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study was a randomized controlled trial studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients between metformin with pulmonary tuberculosis standard treatment group and placebo drug with pulmonary tuberculosis standard treatment.

NCT ID: NCT05190146 Active, not recruiting - Clinical trials for Tuberculosis, Pulmonary

Epidemiologic Study to Assess the IGRA Positivity in Populations With a High TB Burden

Start date: December 20, 2021
Phase:
Study type: Observational

The purpose of this study is to conduct a multi-country, multi-site, epidemiologic study designed to assess the proportion of interferon gamma release assay (IGRA) positivity, at site level, and to build capacity to conduct a future TB vaccine efficacy study.

NCT ID: NCT05148949 Recruiting - COVID-19 Clinical Trials

Study on Three Doses of an Inactivated COVID-19 Vaccine in Chinese Pulmonary Tuberculosis Patients

Start date: December 22, 2021
Phase: Phase 4
Study type: Interventional

This is a randomized, double-blind, parallel-controlled study, for evaluation of safety and immunogenicity of three doses of an inactivated COVID-19 vaccine (CoronaVac) in pulmonary tuberculosis patients aged 18-75 years. 200 tuberculosis patients and 40 healthy adults aged 18-75 years will be recruited in this study. Of them, 200 pulmonary tuberculosis patients will be randomized at a 1:1 ratio to receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac or two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days, respectively. Other 40 healthy subjects served as an external control group will be vaccinated with two doses of standard dosage CoronaVac at a schedule of 0, 28 days. The occurrence of adverse events within 28 days after each dose vaccination and serious adverse events within 3 months after full vaccination will be observed. In addition, blood samples will be collected on day 0 before the first dose and 28 days and 3 months after the last dose vaccination in all participants and 28 days after second dose in pulmonary tuberculosis patients. Each subject will remain in this study for 5 months (healthy group) or 6 months (tuberculosis group).

NCT ID: NCT05122624 Completed - Clinical trials for Tuberculosis, Pulmonary

A Clinical Risk Score for Early Management of TB in Uganda

PredicTB
Start date: November 10, 2021
Phase: N/A
Study type: Interventional

Although curative treatment exists, tuberculosis (TB) remains the leading cause of infectious mortality worldwide - often because people seek care for TB symptoms in highly resource-constrained clinics that cannot provide same-day diagnostic testing. The research team has developed an easy-to-use clinical risk score that, if implemented in these settings, might help clinicians identify patients at high risk for TB and thereby start treatment for those patients on the same day. This study will investigate the effectiveness and implementation of this score in four peri-urban clinics in Uganda, providing critical pragmatic data to inform (or halt) the design of a definitive large-scale cluster randomized trial.

NCT ID: NCT05116098 Not yet recruiting - Tuberculosis Clinical Trials

Randomized Clinical Trial: IS Zinc and Zinc Ionophere EGCG as Supplement Improve Outcome of Active Pulmonary Tuberculosis

Start date: November 30, 2021
Phase: Phase 1
Study type: Interventional

Tuberculosis is still global burden disease at all the word and effect on quality life of patients and affect on health authorities because the cost of medicine and health cost . - A total of 1.4 million people died from TB in 2019 (including 208 000 people with HIV). Worldwide, TB is one of the top 10 causes of death and the leading cause from a single infectious agent (above HIV/AIDS). - In 2019, an estimated 10 million people fell ill with tuberculosis (TB) worldwide. 5.6 million men, 3.2 million women and 1.2 million children. TB is present in all countries and age groups. But TB is curable and preventable. - In 2019, 1.2 million children fell ill with TB globally. Child and adolescent TB is often overlooked by health providers and can be difficult to diagnose and treat. - In 2019, the 30 high TB burden countries accounted for 87% of new TB cases. Eight countries account for two thirds of the total, with India leading the count, followed by Indonesia, China, the Philippines, Pakistan, Nigeria, Bangladesh and South Africa. ( WHO) All TB cases and 92.5% controls were zinc deficient. The odds of TB cases with deficiencies of vitamin A and zinc was 2.3 (95% CI: 1.1 to 4.8) times more likely as compared to the controls. More than 80% of all participants had below average fulfilment of energy and vitamin A intakes. (7) Zinc is necessary for intact immune health and defense against infection but there are common health problem deficiency at developing countries and so zinc needs as supplement and the second problem zinc need helper for transfer through plasma membrane so zinc ionophore is a best solution as this problem so the investigators can use zinc ionophore as helper for zinc to enter the cells for autophagy

NCT ID: NCT05097638 Completed - Clinical trials for Pulmonary Tuberculoses

Lung Health After Tuberculosis: Clinical and Functional Assessment in Post Pulmonary Tuberculosis Egyptian Patients.

Start date: January 20, 2018
Phase:
Study type: Observational

Some of pulmonary tuberculous patients who completed their medication course experience lung function impairment