View clinical trials related to Pulmonary Tuberculosis.
Filter by:Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally. According to recent estimates from the World Health Organization (WHO), over 10 million new cases and 1.6 million deaths from TB occurred in 2021. The vast majority of TB cases and TB deaths are in developing countries. Nigeria has the highest TB burden in Africa with a high number of undetected TB cases as well. The spread of HIV has fueled the TB epidemic, and TB is the leading cause of death among patients infected with HIV and has assumed the lead position as the number one infectious disease cause of death globally. Even though the COVID-19 was associated with a huge mortality, TB contributed significantly to death and one of the single predictors of death among COVID-19 infected individuals. TB predominantly affects young adults in their most productive years of life and has substantial impact on economic development. Emerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatment regimen. The ATORTUB group recently completed Phase II A and Phase IIB studies to assess the safety, tolerability and efficacy of atorvastatin when administered with the current standard of care. The investigators demonstrated that atorvastatin is well tolerated, save, and has beneficial microbiological and radiological impacts in tuberculosis, thus, warrants further studies. This phase IIC trial sets out to evaluate the safety and efficacy of different doses of atorvastatin containing regimen, determine rate of decline of viable sputum bacilli, the time to stable sputum conversion, improvement in chest ray severity scores and lung function parameters post randomization in the different treatment arms. The phase II C is a Selection Trial with Extended follow-up STEP and has been devised as a pilot phase III where patients are studied for longer period (12months post randomization) than the usual phase IIB. Thus, providing additional data that will justify a successful phase III trial.
Tuberculosis (TB) can leave numerous sequelae, where survivors experience a transition from an acute illness to living with a multifaceted chronic illness. Post-TB lung disease (PD-PTB) encompasses lung diseases and pathologies that occur after one or more episodes of TB, which can affect the patient's lung health and cause disabling symptoms that strongly affect their long-term health. In 2020, it was estimated that there were 155 million TB survivors still alive worldwide, with a large proportion of them carrying functional sequelae with profound socioeconomic repercussions. Thus, the aim of this study is to evaluate the effect of pulmonary rehabilitation (PR) on functionality and health-related quality of life (HRQoL) of people with PD-PTB and to build a PD-PTB severity scoring system based on the data. of pre-RP individuals using artificial intelligence technique.
The UNITE4TB consortium is a group of universities and pharmaceutical companies funded by the European Union. This consortium are carrying out a trial to find better and faster ways to treat tuberculosis (TB). The standard treatment for TB takes 24 weeks and uses four drugs. The consortium want to find new treatments that are faster but just as safe and effective. In the trial, two new drugs will be used, BTZ-043 and GSK3036656, along with the drugs that are already used to treat TB in a variety of combinations (11 different combinations initially). These new drugs have worked well in tests with animals and have reduced the amount of TB bacteria in people's sputum/phlegm when used alone for two weeks. These new drugs will be used in combination with other TB drugs for a longer time (up to 16 weeks) in people with TB. The UNITE4TB consortium want to see if they work well and are safe. This trial will take place at sites across the world and will involve people with TB of the lungs that would usually respond well to the standard treatment. But the new treatments being tested might also work for people with drug resistant TB, that's harder to treat. The trial has two parts. In the first part, different combinations of drugs will be tried on up to 700 people for 16 weeks. These combinations will be compared to the standard 24-week treatment to see which ones work the best and are safe. In the second part, the best combinations from the first part will be taken to try to find out what the best length of time is to give the treatment for. These combinations will be tried on up to 1800 people giving them either 8, 10, 12, 14 or 16 weeks treatment. The investigators will follow these people for a total of 72 weeks to make sure the treatment is working. The UNITE4TB consortium hope that this trial will find new treatments that are fast, safe, and effective for both regular TB and resistant TB. If it works, it can then be tested again in a bigger trial to be sure.
Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide. In France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019. Pulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis. The aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.
The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are: - Is the efficacy of short regimen non-inferior to standard regimen? - Is the short regimen safe enough to replace the standard regimen? Participants will: - Be given with either short or standard regimen for RR-TB treatment - Be asked to complete the scheduled visit as planned.
The goal of this clinical trial is to evaluate 3 dose levels of TBAJ876 for 8 weeks in combination with pretomanid and linezolid, compared to 8 weeks of Isoniazid, rifampicin, pyrazinamide and ethambutol (2HRZE), in adult participants with newly diagnosed, smear-positive, pulmonary drug sensitive tuberculosis (DS-TB). The main questions the trial aims to answer are: - What is the optimal dose of TBAJ876 to continue further in development. - What is the bactericidal activity of bedaquiline with pretomanid and linezolid (B-Pa-L) compared to 2HRZE and TBAJ876-Pa-L over 8 weeks - What is the efficacy and safety of the 26-week B-Pa-L regimen compared with the SOC (2HRZE/4HR) in participants with DS-TB. Participants will be seen regularly during treatment (up to 26 weeks) and follow-up (52 weeks post treatment) for safety and efficacy assessments, including but not limited to: - Safety labs, ECGs, vital signs, physical exams, PK sampling, neuropathy assessments and adverse event monitoring - Sputum collection
This multicenter, two-stage, open-label, randomized trial will aim to assess the efficacy, safety, optimal duration, and pharmacokinetics (PK) of Delamanid, Bedaquiline, OPC-167832, and Sutezolid (DBOS) and Pretomanid, Bedaquiline, OPC-167832, and Sutezolid (PBOS) in adult participants with drug sensitive tuberculosis (DS-TB) and rifampicin or multi-drug resistant TB (RR/MDR-TB).
This is a phase 2B/C, open label platform study that will compare the efficacy, safety of 3 experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.
The purpose of this study is to evaluate the efficacy and tolerability of the complex therapy of drug-resistant respiratory tuberculosis using the drug Ingaron, a lyophilisate for the preparation of a solution for injection for intramuscular or subcutaneous administration of 500,000 IU.
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).