Checking TB drug levels to guide dosing in adults with lung tuberculosis
Tests whether model-based dose guidance helps adults with lung tuberculosis get the right drug levels.
Plain-language title generated from the registry record
Registry title: DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Key facts
- Where
- Linköping and Stockholm, SwedenSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with confirmed lung tuberculosis who are being treated, or will be treated, with rifampin. Doctors use drug levels to adjust doses early.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed tuberculosis of the lungs, shown by Mtb culture or PCR for Mtb in routine care
- Earlier treatment
- Treatment with rifampin that includes rifampin is ongoing or planned. Rifampin treatment must not have lasted longer than 8 weeks before joining.
Main reasons for not taking part
- Rifampin treatment for longer than 8 weeks before joining
- Intravenous rifampin, including intensive care patients or brain TB
- Rifampin drug level already measured in routine care more than 24 hours before joining
- TB outside the lungs without lung TB
Read by machine on 12 November 2026.
Where in Sweden
- Linkoping University HospitalLinköping, SwedenContact: Katarina Niward Senior Consultant, PhD, MDTaking people
- Karolinska University HospitalStockholm, SwedenContact: Lina Davies Forsman Senior Consultant, Ass. Professor, PhD, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Karolinska Institutet
- Trial code
- NCT06585358
- Record updated
- 21 November 2025
- Original description
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.Read full original descriptionShow less
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
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.
Inclusion: 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: 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.