Rifampicin Resistant Tuberculosis

This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa. The goal of this clinical trial is to learn whether a 6-month MDR-END Plus regimen works as well as current standard of care (SoC) treatment for rifampicin-resistant tuberculosis. The trial will also learn whether the MDR-END Plus regimen is safer and easier to tolerate than SoC regimens. The main questions this trial aims to answer are: * Does the MDR-END Plus regimen lead to a favorable treatment outcome 12 months after treatment is stopped, compared with SoC regimens? * Do participants receiving the MDR-END Plus regimen have fewer important safety or tolerability problems during treatment and up to 90 days after treatment is stopped, compared with SoC regimens? Researchers will compare the MDR-END Plus regimen with South African standard of care (SoC) treatment for rifampicin-resistant tuberculosis. Participants will: * Be randomly assigned to receive either the MDR-END Plus regimen or SoC treatment. * Take tuberculosis medicines for about 6 months, although treatment may be extended in some cases. * Attend study visits during treatment and after treatment is stopped. * Have clinical assessments, blood tests, heart tracing tests, vision and nerve assessments, and tuberculosis tests. * Be followed for 12 months after treatment is stopped.

This study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the safety, tolerability, and preliminary efficacy of acetohydroxamic acid (AHA) capsules combined with short-course regimens (BDLLfxC or BDCZ) in patients with multidrug-resistant tuberculosis (MDR-TB). The primary objectives are to assess the safety and tolerability of AHA combined with short-course regimens, and to determine the recommended phase II dose (RP2D) of AHA. The secondary objectives include evaluating the 8-week sputum culture conversion rate, pharmacokinetic parameters, and exploring DNA damage repair biomarkers as potential indicators of treatment response.

This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)/clofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-resistant) tuberculosis for 8 weeks.

The goal of this clinical trial is to learn if the all-oral, shorter-course BLMZ regimen can treat Rifampicin-Resistant Tuberculosis (RR-TB) in Chinese participants aged 12 years and older. The main questions it aims to answer are: What is the proportion of participants with a favorable outcome at 18 months after starting the BLMZ regimen? What is the safety profile of the BLMZ regimen, as measured by the incidence of Grade 3 or higher adverse events and serious adverse events during the treatment period? This is a single-arm study, so there is no comparison group. Researchers will compare the study results to historical data to see if the BLMZ regimen shows sufficient efficacy and safety in the Chinese population. Participants will: Undergo screening tests to confirm eligibility, including tests for TB bacteria and drug resistance. Receive the BLMZ regimen (Bedaquiline, Linezolid, Moxifloxacin/Levofloxacin, and Pyrazinamide) orally for 9 months. Attend regular clinic visits for safety assessments, medication refills, and tests (e.g., sputum tests, blood tests, ECG, CT scans) during the 9-month treatment period and then every 3 months during a 15-month post-treatment follow-up period until 24 months after starting the treatment.

The INSPIRE-TB study is a pragmatic, multicentre, randomised, controlled, non-inferiority open-label trial to evaluate the efficacy and safety of seven 9-month oral regimens compared to a 9-month standard of care (SOC) regimen in RR-TB participants susceptible to fluoroquinolones, and a bedaquiline-containing 9-month oral regimen compared to a 20-month conventional regimen in RR-TB participants resistant to fluoroquinolones

A major obstacle in the fight against multidrug-resistant tuberculosis is its treatment. In 2021, only 60% of patients with MDR/RR tuberculosis who received treatment globally were successfully cured, while 12% succumbed to the disease and 10% experienced treatment failure. In France, a recent study by the National Reference Centre for Mycobacteria showed that while MDR/RR tuberculosis patients treated between 2006 and 2019 in the major reference centres in the Paris region achieved a favourable outcome in 68% of cases, 30% were lost. The main aim of this study is to enhance our understanding of the outcomes for patients suffering from tuberculosis due to rifampin-resistant bacilli, as well as the factors influencing these outcomes. Additionally, it aims to decrease the duration required to relay information to health authorities regarding the status of multidrug resistance and the outcomes of patients in France. A national longitudinal cohort will be develop to study multidrug-resistant tuberculosis in France. The cohort includes a historical retrospective part from 2006-2019 and a prospective part from 2020, with planned inclusions until 2029. The restrospective cohort includes 298 patients from 2006-2019 and 178 patients from the CNR mycobacteria national registry until 2024. As for the prospective cohort arm, a projected total of roughly 300 patients will be included over the period from 2020 to 2029. Non-identifying clinical data will be derived exclusively from patients medical records at three expert centres in the Paris region for the restrospective cohort and throughout France (national register) for the prospective cohorte. For the retropective cohorte each centers will transcribe pseudonymised clinical data into secure Excel files, while the prospective cohort will enter non-identifying data directly into the national register using a secure platform overseen by the CNR of Mycobactéria. Registry data will be extracted directly from the registry and merged with the retrospective database every 12 months by the coordinating investigator. Statistical analyses will include descriptive analyses of continuous and categorical variables, comparisons between subgroups using appropriate tests (Student's t, Mann-Whitney, Chi Square, Fisher), and logistic regressions to identify variables associated with treatment outcomes. P value \< 0.05 will be considered statistically significant