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Tuberculosis, Pulmonary clinical trials

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NCT ID: NCT04055584 Recruiting - Clinical trials for Tuberculosis, Pulmonary

PCR Techniques of Dried Sputum Using a Spotcard

Start date: July 2, 2019
Phase:
Study type: Observational [Patient Registry]

Molecular testing for mutations in M. tuberculosis genes associated to resistance of anti tuberculosis (TB) drugs is already part of standard laboratory TB diagnostic. This implicates earlier knowledge of possible resistance and thus prevents unnecessary treatment and the chance of treatment failure or treatment related toxicity. The molecular laboratory diagnostics is widely spread in high income, low TB endemic countries. However, the low income countries lack widespread facilities to test for susceptibility, either genotypic or phenotypic. Performing molecular diagnostics on sputum collected with a spot card could improve accessibility to molecular testing. This study examines if sputum collected and put on spot cards could be used for multiple molecular tests for the detection, identification and susceptibility prediction of TB. This means that DNA extraction of the sputum from the spot card should be feasible. The study is a pilot study with adult patients of the tuberculosis department of University Medical Centre Groningen (UMCG) Beatrixoord, Haren as subjects. The sputum produced will be collected, dried on spot cards, and DNA extraction from the card will be tested. If molecular detection is positive for the tuberculosis bacteria additional tests will be performed. Based on the present/absent of mutations in the genes associated to resistance susceptibility can be preditec, different molecular techniques will be performed to identify possible mutations. Furthermore, sputum will be collected as patients produce so. Sputum samples with low bacterial load can be tested as well and can test the sensitivity of the procedure. Lastly, techniques like RNA detection will be tested to identify the bacterial load. This can be done if more than one sample of patients were collected. Subjects will be selected on age, participation in standard TDM and drug use. Demographic parameters will be analysed. Sputum samples will be taken twice a week (on Tuesday and Friday).

NCT ID: NCT03967353 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Study on the Management Model of "Home Treatment" for Tuberculosis Patients

Start date: March 22, 2018
Phase: N/A
Study type: Interventional

This project aims to standardize the management of "home treatment" for tuberculosis patients, improve the compliance of patients with treatment, reduce the risk of transmission, and study the establishment of "home treatment" management model for tuberculosis patients.

NCT ID: NCT03851159 Recruiting - Tuberculosis Clinical Trials

Nyaditum Resae® as a Co-adjuvant During Treatment for Active Pulmonary Tuberculosis and Its Impact on the Gut Microbiota

Start date: May 10, 2019
Phase: N/A
Study type: Interventional

This will be the first study to evaluate the use of Nyaditum resae® as a potential agent for reducing antibiotic-associated gut dysbiosis in patients with drug-susceptible TB, and potentially improving clinical and microbiological markers of outcome

NCT ID: NCT03702738 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Adjunctive NAC in Adult Patients With Pulmonary Tuberculosis

NAC-TB
Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

To determine if adjunctive N-acetylcysteine 1200 mg twice a day (BID) accelerates sputum culture conversion and normalization of cellular glutathione in tuberculosis (TB), and to assess its potential effects on lung and immune function

NCT ID: NCT03478033 Recruiting - AIDS Clinical Trials

Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis

RRHT
Start date: April 15, 2018
Phase: N/A
Study type: Interventional

To compared the efficacy and safety of rifampicin and rifabutin which included in the standard treatment of anti-tuberculosis in HIV/AIDs patients combined with pulmonary tuberculosis, a multi-center, prospective cohort will be established. Antiviral efficacy and drug drug interaction will be investigated in order to provide optimized treatment for HIV/AIDs with tuberculosis.

NCT ID: NCT03416309 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Personalization of AntiTB Treatment: Evaluation of Pharmacological Determinants of Treatment Response

PAT
Start date: May 25, 2017
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to investigate the possible correlation of plasma drug concentrations with Time To Positivity (TTP) in liquid culture in patients with active pulmonary multi sensitive TB in the first two weeks of treatment. Secondary aims are: the correlation between plasma drug concentrations and hepato/neuro toxicity; the impact of different allelic variants on PK data, toxicity and TTP in liquid culture; the feasibility of using dried blood/plasma spots to measure plasma concentrations of anti-TB drugs and determine genetic polymorphisms.

NCT ID: NCT03281226 Recruiting - HIV/AIDS Clinical Trials

RIPE vs RIPE Plus N-acetylcysteine in Patients With HIV/TB Co-infection

RIPENACTB
Start date: December 7, 2016
Phase: Phase 2
Study type: Interventional

Although tuberculosis is a treatable disease, it is currently the infectious disease with the highest mortality in the world. It is estimated that one-third of the world's population is infected. HIV is the main predisposing factor for TB development. The Brazilian Ministry of Health and the World Health Organization recommends that patients should initially be treated orally with RIPE - rifampicin (R), isoniazid (I), pyrazinamide (P) and ethambutol (E). The N-acetylcysteine (NAC) first benefit was reported during the 1960s, when it proved to be an effective mucolytic agent in individuals with cystic fibrosis. Later, a new role arose when investigating its therapeutic potential in acetaminophen intoxication. Cleavage of the acetyl group makes cysteine available for later incorporation into glutathione synthesis, decreased in hepatic injury caused by acetaminophen. This mechanism causes NAC to have an indirect antioxidant effect, which aroused an interest in studying the effect in diseases that occur with oxidative stress. TB and HIV/Aids are also diseases with chronic inflammation. The present study aims to evaluate the effects of NAC as a adjuvant therapy in the treatment of TB. This is a phase II randomized clinical trial in which the safety and tolerability of NAC as adjunctive therapy for TB treatment will be assessed. Fifty-six patients will be randomized into two groups. The first group will receive the standard tuberculosis treatment as recommended by the Brazilian Ministry of Health (RIPE); the second will receive in addition to this treatment 1200mg of NAC per day for two months. In this way, microscopy and culture conversion rate to mycobacteria at 8 weeks, levels of glutathione and biomarkers of immune activation and inflammation in case of TB with or without NAC will be monitored.

NCT ID: NCT03220464 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Early Diagnosis of Active Tuberculosis Using Ultra Low-dose Chest CT

Start date: June 20, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate ultra low dose chest computed tomography (ULDCT) for early diagnosis of active tuberculosis in cohort of close contacts of active pulmonary tuberculosis for 1 year follow up

NCT ID: NCT03025516 Recruiting - Pulmonary TB Clinical Trials

Performance Evaluation of TB Breath- and Cough-testing Platforms

Start date: May 29, 2017
Phase: N/A
Study type: Observational

This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy of two TB breath-based technologies independently of the manufacturers. Assay error and failure rates and device operational characteristics will also be assessed during this study. Participants will be enrolled in this study in line with FIND sample banking activities. Results from index tests will not be used to make clinical decisions. Participation in this study will not alter the standard of care.

NCT ID: NCT02972697 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Evaluation of 11C-acetate PET Imaging as a Novel Approach to Detecting Pathology in Pulmonary TB

Start date: November 2016
Phase: Phase 1
Study type: Interventional

Imaging using 11C-acetate PET (positron emission tomography) in patients with tuberculosis (TB) may be able to detect non-replicating persister bacilli. This may permit identification of those patients at risk of relapse following completion of TB treatment. The main aim of this pilot study is to assess the ability of 11C-acetate PET to detect pulmonary lesions in individuals with active pulmonary TB.