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Tuberculosis clinical trials

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NCT ID: NCT03625739 Recruiting - Tuberculosis Clinical Trials

Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis

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

This study is based on the hypothesis that the pharmacokinetics of anti-tuberculosis drugs in TB children are different from adults. The investigators aim to study the population pharmacokinetics of children receiving the anti-tuberculsis drugs for treatment of TB. In this study, the investigators will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models. In addition, the investigators also want to correlate use of anti-tuberculsis drugs with treatment effectiveness and incidence of adverse effects in children. This novel knowledge will allow better and more rational approaches to the treatment of TB in children. It will also set the foundation for further studies to improve anti-tuberculosis drug therapies for children.

NCT ID: NCT03575299 Recruiting - Clinical trials for Multi-drug Resistant Tuberculosis

Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells

MDR-TB
Start date: June 1, 2018
Phase: Phase 1
Study type: Interventional

Brief summary: Allogeneic γδT cells from healthy donor will be administrated intravenously to patients with the MDR-TB,and then the safety and efficacy of γδT cells will be evaluated.

NCT ID: NCT03568383 Recruiting - Tuberculosis, MDR Clinical Trials

Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

PHOENIx MDR-TB
Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of 26 weeks of delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active tuberculosis (TB) during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB) (index cases). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.

NCT ID: NCT03507816 Recruiting - Tuberculosis Clinical Trials

A Multidrug-resistant (MDR) and Extensively Drug- Resistant (XDR) Tuberculosis Study in Alsace

Start date: February 23, 2018
Phase:
Study type: Observational

The purpose of this study is to examine the epidemiology of TB MR in Strasbourg and evaluate the second-line anti-tuberculosis treatments effectiveness, and the relevance and adequacy of the treatments with WHO recommendations. During years 2006-2016, all new cases of MDR TB or XDR TB diagnosed Strasbourg University Hospital will be included in the study (22 cases). Data were collected from the Center for Tuberculosis Control (CLAT) records, the patient's medical records.

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: NCT03474029 Recruiting - Latent Tuberculosis Clinical Trials

Assessment of the Safety, Tolerability, and Effectiveness of Rifapentine Given Daily for LTBI

ASTERoiD
Start date: August 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This study is conducted to compare the safety and effectiveness of a novel short 6-week regimen of daily rifapentine (6wP, experimental arm) with a comparator arm of 12-16 weeks of rifamycin-based treatment (standard of care, control arm) of latent M. tuberculosis infection (LTBI). This trial is conducted among persons who are at increased risk of progression to tuberculosis (TB) and require treatment of LTBI. The study will be conducted in low, medium and high TB incidence settings that have treatment of LTBI as their standard of care and offer 12-16 week rifamycin-based therapy as standard of care. The hypothesis of this study is that the safety and effectiveness of the experimental treatment (6wP arm) is non-inferior to a comparator arm of 12-16 weeks of rifamycin-based treatment of LTBI (control arm). Participants are enrolled and randomly assigned to one of the two study arms: experimental 6wP or control. The comparator (control) arm's treatment regimens include 12 weeks of once-weekly isoniazid (INH) and rifapentine (3HP), 12 weeks of daily INH and rifampin (3HR), and 16 weeks of daily rifampin (4R). A total of 560 participants per arm (1,120 total) for the evaluation of safety and 1,700 participants per arm (3,400 total) for the evaluation of effectiveness will be enrolled, given treatment as per randomization assignment, and followed for 24 months from the date of enrollment. After completion of data collection, statistical analyses will be conducted to compare proportions of drug discontinuation due to adverse drug reaction (ADR) and proportions of newly diagnosed tuberculosis between 6wP and control arm.

NCT ID: NCT03423550 Recruiting - Tuberculosis Clinical Trials

Development of a Rapid and Accurate Diagnostic Assay for Tuberculosis

Start date: January 16, 2018
Phase:
Study type: Observational

This study evaluates new technique for diagnosis of tuberculosis. Among patients who are suspected with tuberculosis, participants will be tested conventional method including Xpert TB/RIF assay, and new diagnostic technique using homobifunctionalImidoesters compounds.

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: NCT03409315 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients

PERFECT
Start date: February 10, 2018
Phase:
Study type: Observational

Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice. In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.

NCT ID: NCT03363178 Recruiting - Tuberculosis Clinical Trials

Study to Investigate the Safety and Efficacy of GC3107 (BCG Vaccine) in Healthy Adults

Start date: December 14, 2017
Phase: Phase 1
Study type: Interventional

Healthy adults will be once administered GC3107(BCG Vaccine) Intradermally.