DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Karolinska Institutet
30 participants
Nov 1, 2025
OBSERVATIONAL
Conditions
Summary
The goal of this observational study is to investigate whether model-informed precision dosing (MIPD), as a clinical support for early individualised dosing in addition to the national TB care program, can optimise the drug exposure of TB drugs during TB treatment. Main research questions: In adult patients with drug-susceptible pulmonary tuberculosis, can current dose recommendations and information received from MIPD help clinicians in a timely manner to optimise the drug exposure of TB drugs in the early treatment phase, i.e., the time from PK sampling to dose adjustment (keep or adjust dose)? Specific aims I. To perform a process evaluation of early MIPD for rifampicin, isoniazid, pyrazinamide and ethambutol during active TB treatment. II. To study the target attainment of first-line TB drugs with MIPD. III. To evaluate model precision of predicted versus detected drug concentrations. Drug concentrations will be measured in study participants during TB treatment, and drug exposure and the optimal dose will be predicted by MIPD using pharmacokinetic population models.
Eligibility
Inclusion Criteria3
- Adult persons ≥18 years with confirmed pulmonary TB (established through Mtb cultures or PCR for Mtb by clinical routine)
- Ongoing or planned treatment of TB that includes rifampin
- Written informed consent
Exclusion Criteria4
- TB treatment with rifampin for longer than 8 weeks prior to inclusion
- TB treatment with intravenous rifampin (including patients treated at an intensive care unit (ICU) or patients with cerebral TB)
- TDM of rifampin has already been performed (\>24 h before inclusion) by clinical routine
- Study participants with extrapulmonary TB without pulmonary TB.
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Interventions
This is a non-inverventional study
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06585358