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Multidrug Resistant Tuberculosis clinical trials

View clinical trials related to Multidrug Resistant Tuberculosis.

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NCT ID: NCT05534750 Recruiting - Tuberculosis Clinical Trials

Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)

TEDITUB
Start date: April 20, 2023
Phase: Phase 2
Study type: Interventional

The objective of this work is to measure the early bactericidal activity of tedizolid, to compare it with the bactericidal activity of linezolid (reference molecule for the treatment of multidrug-resistant tuberculosis) and with that of standard quadruple therapy (reference treatment of drug susceptible tuberculosis).

NCT ID: NCT05081401 Recruiting - Clinical trials for Multidrug Resistant Tuberculosis

Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)

INSPIRE-TB
Start date: May 23, 2022
Phase:
Study type: Observational

The purpose of this study is to assess the efficacy and safety of a molecular drug-sensitivity test-guided individualized shorter all-oral regimen composed of 4-5 anti-tuberculosis drugs recommended by WHO in RRTB patients for 9-12 months in real-world practice, in some high RR-TB burden province of China. This study hopes to form a clinical pathway of all oral short-term treatment based on the guidance of rapid molecular drug sensitivity that can be popularized in China, and update the Chinese guidelines of RR-TB treatment management.

NCT ID: NCT05017324 Recruiting - Clinical trials for Multidrug Resistant Tuberculosis

Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial

SMARTT
Start date: September 21, 2021
Phase: N/A
Study type: Interventional

The primary aim of this pragmatic trial is to determine the effectiveness of a Whole Genome Sequencing (WGS) Drug Sensitivity Testing (DST) strategy to guide individualised treatment of rifampicin resistant tuberculosis (RR-TB) patients. The primary objective is to determine the effectiveness of this WGS DST strategy in patients diagnosed with RR-TB. We will additionally perform an exploratory health economics evaluation of both arms, and will determine the feasibility of the WGS DST strategy.

NCT ID: NCT04717908 Active, not recruiting - Clinical trials for Multidrug Resistant Tuberculosis

Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS

TB-TRUSTplus
Start date: January 20, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of bedaquiline, linezolid, cycloserine, clofazimine and pyrazinamide treatments guided by PZA sensitivity for 24 to 36 weeks in subjects with fluoroquinolone-resistant MDR-TB .

NCT ID: NCT04484129 Not yet recruiting - Clinical trials for Multidrug Resistant Tuberculosis

MDR-TB Close Contacts Tracing in China (TCCT Study)

Start date: July 21, 2020
Phase:
Study type: Observational

To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.

NCT ID: NCT04421495 Active, not recruiting - Clinical trials for Multidrug Resistant Tuberculosis

Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China

Start date: July 16, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to monitor and evaluate the safety and effectiveness of Delamanid in combination with an optimal background regimen (OBR) of anti-TB drugs for treatment of MDR-TB.

NCT ID: NCT04260477 Active, not recruiting - Tuberculosis Clinical Trials

Novel Triple-dose Tuberculosis Retreatment Regimen

Tri-Do-Re
Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).

NCT ID: NCT03942354 Completed - Clinical trials for Multidrug Resistant Tuberculosis

Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

PRACTECAL-PRO
Start date: September 1, 2019
Phase:
Study type: Observational

PRACTECAL-PRO is a sub-study of a TB-PRACTECAL clinical trial for multidrug resistant Tuberculosis. It evaluates the effectiveness of TB-PRACTECAL interventions from the patient perspective in terms of their quality of life, shared decision making and satisfaction with services.

NCT ID: NCT03867136 Active, not recruiting - Clinical trials for Multidrug Resistant Tuberculosis

Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)

TB-TRUST
Start date: June 1, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of a combination of levofloxacin, linezolid, cycloserine and pyrazinamide (or clofazimine if resistant to pyrazinamide) treatments for 24 to 32 weeks (regimen consisted of clofazimine for 36~44 weeks) in subjects with multidrug-resistant tuberculosis (MDR-TB) compared to WHO standardized shorter regimen of 36-44 weeks.

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

GRACE-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.