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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating the use of therapeutic drug monitoring TDM to optimize the dosage of linezolid, a key drug in the BPaLBPaL-M regimen, for patients with multidrug-resistant tuberculosis MDR-TB. This study addresses the challenge of balancing linezolids effectiveness with its serious side effects, such as neuropathy and myelosuppression, which occur in a significant number of patients. The goal is to improve treatment outcomes and reduce adverse events by personalizing linezolid dosing based on blood drug levels. Participants will be randomly assigned to one of two groups. One group will receive the standard linezolid dose of 600 mg with regular TDM monitoring but no dose adjustments unless national guidelines require it. The other group will have their linezolid dose personalized according to TDM results, adjusting the dose based on specific blood concentration thresholds to balance efficacy and safety. Blood samples will be collected frequently during the 6-month treatment, including weekly samples in the first month and monthly thereafter, with additional samples taken if side effects arise. Throughout the study, participants will undergo regular blood sampling to monitor linezolid levels and side effects. Researchers will assess the rate of linezolid-related side effects, treatment success, and trends in drug levels throughout therapy. The total participation time is six months, during which clinical outcomes and the feasibility of dose personalization in low-resource settings will be evaluated.
Actively Recruiting
Researchers are evaluating new treatment recommendations for children with Acute Lymphoblastic Leukemia ALL through the GFAOP group. This observational study aims to improve outcomes by applying precise protocols and logistical support in developing countries. The study includes both standard and high-risk ALL forms, focusing on achieving high remission rates and long-term survival. The treatment approach proposes anthracycline induction for high-risk cases, including children under 1 year or over 10 years, and uses Endoxan and high-dose Methotrexate in consolidation phases. The study also follows previously established protocols for standard risk patients, aiming to refine and confirm effective treatment strategies for children with ALL. Participants will be monitored for treatment feasibility, adherence, remission rates after induction, and survival without relapse over five years. Assessments include checking correct application of therapy within five weeks and complete remission around day 34 to 42 post-induction. The study expects to evaluate outcomes initially after two years and fully by five years, ensuring comprehensive follow-up and data collection throughout the study period.