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

Launched by KAROLINSKA INSTITUTET · Sep 3, 2024

Keywords

ClinConnect Summary

This clinical trial, called DoseTB, is exploring a new way to personalize tuberculosis (TB) treatment using a method called model-informed precision dosing (MIPD). The goal is to ensure patients receive the right amount of TB medications as soon as possible, which can help improve their treatment outcomes. Researchers will look at how well the current dosing recommendations work along with the information provided by MIPD during the early stages of treatment for adults with drug-susceptible pulmonary TB.

To be eligible for this study, participants must be at least 18 years old and diagnosed with pulmonary TB, confirmed through laboratory tests. They should be starting or currently receiving treatment that includes the medication rifampin. However, individuals who have been on rifampin for over eight weeks, those receiving intravenous rifampin, or those with TB only in areas outside the lungs cannot participate. Throughout the trial, participants will have their drug levels monitored to help determine the most effective doses tailored to their needs. The study is not yet recruiting participants, but it aims to make TB treatment more effective for everyone involved.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • 1. Adult persons ≥18 years with confirmed pulmonary TB (established through Mtb cultures or PCR for Mtb by clinical routine)
• • 2. Ongoing or planned treatment of TB that includes rifampin
• • 3. Written informed consent
• • Exclusion criteria
• • 1. TB treatment with rifampin for longer than 8 weeks prior to inclusion
• • 2. TB treatment with intravenous rifampin (including patients treated at an intensive care unit (ICU) or patients with cerebral TB)
• • 3. TDM of rifampin has already been performed (\>24 h before inclusion) by clinical routine
• • 4. Study participants with extrapulmonary TB without pulmonary TB.