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Tuberculosis, Pulmonary clinical trials

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NCT ID: NCT06192160 Not yet recruiting - Clinical trials for Pulmonary Tuberculosis

Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

RAD-TB
Start date: September 15, 2024
Phase: Phase 2
Study type: Interventional

A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB). A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)]. The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

NCT ID: NCT06171646 Completed - Fatigue Clinical Trials

Effect of Breathing Exercise on Fatigue in Patients With Pulmonary Tuberculosis

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Tuberculosis is a chronic, necrotic infectious disease with very different clinical appearances, caused by a group of mycobacteria defined as M. tuberculosis complex. Although there is a vaccine and can be treated with combined medications, this health problem remains important all over the world, especially in poor countries. Generally, respiratory symptoms that occur in a person with tuberculosis include cough, phlegm, hemoptysis, chest pain, and shortness of breath for more than three weeks. If there is a partial obstruction in the bronchi due to the compression of enlarged lymph nodes, it causes a whezing sound accompanied by shortness of breath. In tuberculosis, contagion is brought under control with effective treatment by regular use of drugs. In addition, the symptoms of the patients are relieved until they recover. However, the fatigue of the patients may continue. The disease may continue. In addition to having an effect, fatigue may also occur due to the side effects of many tuberculosis drugs. Therefore, patients experiencing fatigue while taking tuberculosis drugs may cause them to become uncooperative in drug use, multidrug-resistant tuberculosis, serious complications and higher treatment costs. Another method used in addition to the treatment of chronic respiratory system diseases such as tuberculosis is pulmonary rehabilitation.Pulmonary rehabilitation consists of patient education, psychosocial support, aerobic and strengthening breathing exercises and physical training programs. Among the breathing exercises that are considered to be one of the important components of pulmonary rehabilitation, pursed-lip breathing and diaphragmatic breathing exercises are frequently used in chronic respiratory system diseases. However, no study has been found examining the effects of pursed-lip breathing and diaphragmatic breathing exercises on fatigue in tuberculosis patients. Pursed-lip breathing technique ensures maximum emptying of the alveoli by providing controlled expiration, thus helping to reduce the respiratory rate by increasing the activity of the inspiratory and expiratory muscles, increasing gas exchange and tidal volume. During diaphragmatic breathing exercise, since the diaphragm muscle is used instead of accessory muscles, the respiratory load decreases, thus the ventilation level of the lungs increases and breathing is supported. It has been reported in the literature that the deep breathing technique is effective in controlling the emotional states of tuberculosis patients, and that deep breathing exercises applied to pulmonary TB patients are effective in reducing the respiratory rate. However, since no study was found in the literature review that evaluated the effect of breathing exercise applied to TB patients on fatigue, this study was planned to examine the effect of breathing exercise applied to patients diagnosed with TB on fatigue.

NCT ID: NCT06159023 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Conventional Bronchoscope With BAL vs. Thin Bronchoscope With BW to Diagnose Pulmonary TB

Start date: December 15, 2023
Phase: N/A
Study type: Interventional

This study aims to compare the diagnostic yield of bronchoalveolar lavage (BAL) using a thick conventional bronchoscope and bronchial washing (BW) using a thin bronchoscope in the diagnosis of pulmonary tuberculosis.

NCT ID: NCT06157034 Completed - Clinical trials for Pulmonary Tuberculosis

Prokinetic Effect of Selected Nutraceuticals

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural medicines help in alleviating gastrointestinal disturbances. This study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.

NCT ID: NCT06127641 Recruiting - Clinical trials for Pulmonary Tuberculosis

Rehabilitation of People With Post-tuberculosis Lung Disease

Start date: October 28, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06118619 Recruiting - Clinical trials for Respiratory Tuberculosis

A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

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

The main purpose of testing: To confirm the effectiveness and safety of the drug Ingaron when used in patients hospitalized at the research center for various reasons.

NCT ID: NCT06114628 Recruiting - Clinical trials for Pulmonary Tuberculosis

Platform Assessing Regimens and Durations In a Global Multisite Consortium for TB

PARADIGM4TB
Start date: January 9, 2024
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT06110533 Recruiting - Clinical trials for Pulmonary Tuberculosis

Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals

TPE
Start date: April 4, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT06084715 Recruiting - Clinical trials for Tuberculosis, Pulmonary

The INSTITUT Study

INSTITUT
Start date: September 7, 2023
Phase:
Study type: Observational

Undernutrition is a leading global risk factor of tuberculosis (TB) and a prevalent comorbidity associated with TB. In Benin, the National TB Program systematically provides nutritional support to all persons with TB (PWTB), distributing prepared foods to hospitalized patients and food baskets during outpatient care. In Togo, the PWTB population is similar to that of Benin; however, Togo does not have a systematic program in place to provide nutritional support to these patients. The investigators will perform a prospective cohort analysis using anonymized TB patient data from the National TB Programs of Benin and Togo. Participants enrolled in Benin will receive nutritional support from the hospital while those enrolled in Togo will not. Participants in Togo who do not receive nutritional support will serve as a control. Unfavorable outcomes in both groups such as treatment failure, death, or relapse will be compared. The results from this study should help to shape TB programs in the future by incorporating nutritional support.

NCT ID: NCT06081361 Recruiting - Clinical trials for Pulmonary Tuberculosis

Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezolid, Delamanid and Bedaquiline Cohort

INSPIRE-CODA
Start date: December 22, 2023
Phase: Phase 3
Study type: Interventional

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.