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Tuberculosis, Multidrug-Resistant clinical trials

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NCT ID: NCT03830671 Not yet recruiting - Clinical trials for Multi-drug Resistant Tuberculosis

The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB

Start date: March 2019
Phase: N/A
Study type: Interventional

WHO has recommended that multidrug-resistant tuberculosis (MDR-TB, defined as resistance to at least isoniazid (H) and rifampicin (R) be addressed as a public health crisis and enhance capacity to deliver effective treatment and care. According to the 2018 WHO TB Report, the overall treatment success rate of MDR-TB is 55% while much lower in China at just only 41% with the 24-month regimen. In order to further verify the safety and efficiency of optimizing shorter 18-month regimen containing 6 anti-TB drugs with MDR-TB patients,500 more patients will be enrolled and observed.

NCT ID: NCT03828201 Not yet recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

Efficacy and Tolerability of Bedaquiline, Delamanid, Levofloxacin, Linezolid, and Clofazimine for Treatment of Patients With MDR-TB

Start date: January 2020
Phase: Phase 3
Study type: Interventional

Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs. It occurs in 3.6% of newly diagnosed TB patients in the world and 17% of patients who have been previously treated. In 2017, approximately 558,000 people were estimated to have acquired MDR-TB. However, only 25% of persons with MDR-TB were diagnosed and started on treatment, reflecting inadequate diagnostic capacity and lack of TB treatment capacity. The investigators propose to randomize participants with MDR-TB to 16 or 24 weeks of treatment with a 5-drug oral experimental regimen or to the standard World Health Organization (WHO) 9-11-month regimen (the "control" regimen). The primary objective is to assess the non-inferiority of the 24-week experimental regimen. In addition, the study also aims to examine the non-inferiority of an even shorter (16-week) regimen. The proposed investigational regimen combines two new drugs, bedaquiline (BDQ) and delamanid (DLM), with three anti-TB agents of known potency, linezolid (LZD), levofloxacin (LFX), and clofazimine (CF), to provide a shorter, better-tolerated and more effective MDR-TB treatment regimen for persons with fluoroquinolone-susceptible MDR-TB. This regimen can be expected to be effective for the vast majority of MDR-TB patients throughout the world.

NCT ID: NCT03827811 Not yet recruiting - Clinical trials for Multi-drug Resistant Tuberculosis

Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis

Start date: March 1, 2019
Study type: Observational

PandrTB is a study of the pharmacokinetics(PK) and pharmacodynamics(PD) of bedaquiline, delamanid, clofazimine, linezolid, moxifloxacin, levofloxacin and pyrazinamide used in novel combinations to treat multidrug-resistant tuberculosis(MDR-TB).

NCT ID: NCT03822156 Completed - Tuberculosis Clinical Trials

Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort

Start date: January 1, 2010
Study type: Observational [Patient Registry]

This study is a retrospective cohort study. The purpose of this study is to investigate clinical features of the patients with the cavitary pulmonary tuberculosis (TB) and endobronchial TB from the patients who have been registered in this hospital for treatment and follow-up, as part of the "PPM Project (Private-Public Mix project) for Korean National Tuberculosis Control" introduced in Korea since 2007.

NCT ID: NCT03728725 Not yet recruiting - Clinical trials for Tuberculosis, Pulmonary

Xpert MTB/XDR Clinical Evaluation Trial

Start date: April 2019
Study type: Observational

FIND and partners intend to address the need for a multi- and extensively drug-resistant tuberculosis (M/XDR-TB) diagnostic solution for patients in settings with a high burden of drug-resistant tuberculosis (DR-TB) though the development, evaluation and introduction of an Xpert MTB/XDR assay

NCT ID: NCT03604848 Not yet recruiting - Clinical trials for Multidrug Resistant Tuberculosis

NGS-Guided(G) Regimens(R) of Anti-tuberculosis(A) Drugs for the Control(C) and Eradication(E) of MDR-TB

Start date: August 5, 2018
Phase: N/A
Study type: Interventional

Tuberculosis (TB) has been one of the top 10 causes of death worldwide from a single infectious agent, ranking above HIV/AIDS. Management and eradication of this disease is being hindered by the emergence of multidrug-resistant TB (MDR-TB) and extensively drug resistant TB (XDR-TB). Globally, there were estimated 10.4 million cases of TB and 490,000 cases of MDR-TB in 2016. China accounts for around 8.6% (0.895/10.4 million) of the global TB burden, ranking third in the top 3 countries (India, Indonesia, China) with the highest number of TB cases and ranking first with the largest number of MDR/ Rifampin-Resistant (RR)-TB cases. The treatment success rate for MDR-TB using the 18-24-month conventional World Health Organization (WHO) regimen was estimated to be about 54% worldwide and 41% for China in 2016, which remains unacceptably low. The poor MDR-TB treatment success rates suggest that current drug regimens are suboptimal. In addition, they are costly with a high pill burden, as many drugs, with significant potential for adverse events, are given for a long duration. These factors also inhibit good treatment compliance with further negative impact on treatment outcomes. According to previous studies, treatment outcomes of MDR-TB could be affected by drug resistance of pivotal drugs in MDR-TB regimen, such as fluoroquinolones, second-line injectable agents and pyrazinamide. The available drug-resistance information could help physicians decide the proper regimens for MDR-TB patients, which may prevent the useless prescription and evitable adverse. Therefore, the individualized regimen based on the resistance profile of the bacteria and patients' drug tolerance should be aimed for high-quality treatment for MDR-TB in the future. A precision individualized treatment approach based on the rapid molecular drug susceptibility tests of second line drugs may assist clinicians in making more suitable regimen and improve the treatment outcome of MDR-TB. Also, precision regimen offers the opportunity to improve treatment of drug-resistant tuberculosis through reduced toxicity while reducing the risk of resistance amplification and further transmission at a population level. The purpose of this research is to assess the feasibility and effects of individualized regimen that is guided by rapid molecular drug susceptibility tests of key second-line drugs through next generation sequencing. Meanwhile, the study will evaluate a short course regimens of drugs among "simple MDR-TB" patients who are proven to be sensitive to fluoroquinolones ,injectable second-line drugs and pyrazinamide.

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

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

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 Not yet recruiting - Tuberculosis, MDR Clinical Trials

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

Start date: March 15, 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: NCT03470233 Recruiting - Clinical trials for Multi-drug Resistant Tuberculosis

Deltyba Registry in MDR-TB Patients

Start date: May 16, 2017
Study type: Observational

Deltyba Registry aims to collect the usage information of Deltyba which could be a factor of developing resistance in actual clinical settings.

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

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

Start date: February 10, 2018
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.