DoseTB: Individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis

What this Trial Is About

This research aims to explore whether model-informed precision dosing (MIPD) can help optimize the drug levels of tuberculosis (TB) medications during early treatment in adults with drug-susceptible pulmonary tuberculosis. The study investigates if current dosing guidelines combined with MIPD can support timely dose adjustments to improve treatment outcomes. The focus is on first-line TB drugs including rifampicin, isoniazid, pyrazinamide, and ethambutol. Participants will receive standard TB treatment following national care programs, with MIPD used as a clinical support tool to predict drug exposure and recommend dose adjustments early in therapy. This observational study does not involve administering experimental treatments but rather monitors how MIPD influences dosing decisions and drug concentrations. Drug levels will be measured during treatment to compare predicted versus actual concentrations and to assess the effectiveness of dose optimization. Throughout the study, participants will have pharmacokinetic sampling to monitor drug levels, with dose recommendations provided within the first five days after sampling. Researchers will evaluate the proportion of patients whose doses are adjusted based on predictions, the accuracy of the model in estimating drug exposure, and overall target drug levels achieved during approximately one month of treatment. The study includes informed consent and ongoing observation of participants receiving TB care over this period.

DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis