Personalizing Linezolid Dosage Using Therapeutic Drug Monitoring During Treatment of Multidrug-Resistant Tuberculosis with the BPaL Regimen

What this Trial Is About

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.

Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment