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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying multidrug-resistant tuberculosis (MDR-TB), a major global health challenge with a low treatment success rate worldwide. The World Health Organization estimates 400,000 MDR-TB cases in 2023, with only 44% diagnosed and treated. In Guinea, about 450 patients have MDR-TB, with a 74% success rate using a 9-month oral regimen. Since 2022, WHO recommends a 6-month BPaL/BPaL-M regimen, which Guinea started in January 2025. Linezolid, a key drug in this regimen, is effective but can cause serious side effects like myelosuppression and peripheral neuropathy, leading to treatment discontinuation in some cases. Blood levels of linezolid above 2 mg/l are linked to side effects, but these levels vary widely between patients. This study evaluates how therapeutic drug monitoring (TDM) can help personalize linezolid dosing during the BPaL/BPaL-M treatment to reduce side effects without compromising effectiveness. Participants receive linezolid doses adjusted based on TDM results: doses are decreased if levels are above 2 mg/l, increased if below 0.6 mg/l, or kept the same if between these levels. Dose adjustments are done carefully, with repeated TDM after one week, and doses can range from 300 mg every other day up to 1200 mg daily. Participants with MDR-TB will be monitored from enrollment through six months of treatment to assess the rate of linezolid-related side effects. Researchers will collect data on adverse events, treatment outcomes, and TDM trends over time. The study aims to compare patients whose doses are personalized by TDM with those on the standard dose, to better understand the benefits and risks of dose adjustments. Safety and treatment success will be carefully followed throughout the study period.
Actively Recruiting
Researchers are evaluating treatment recommendations for children with Acute Lymphoblastic Leukemia (ALL), focusing on redefining risk criteria and introducing new induction and consolidation therapies for high-risk cases. This study, conducted by the GFAOP group, builds on previous work aimed at improving the prognosis of children with ALL in developing countries by using precise protocols and logistical support. The goal is to confirm the feasibility of these recommendations and achieve a complete remission rate close to 85% after induction treatment, with an expected 65% survival without relapse at 5 years. The study follows the LALGFA2019 recommendations, which include anthracycline induction for high-risk patients, such as those with leukocytosis greater than or equal to 50 G/L, children under 1 year old or over 10 years old, and the use of Endoxan and high-dose Methotrexate in consolidation therapy. The treatment is aimed at both standard and high-risk forms of ALL, with careful application of therapeutic protocols. Participants will be monitored for the feasibility and correct application of these treatment recommendations, with key outcome measures assessed at 5 weeks, 2 years, and 5 years. The study will track complete remission rates post-induction and long-term outcomes including survival without relapse. This comprehensive monitoring aims to evaluate both short-term treatment success and long-term patient outcomes over a five-year period.