Individualised model-informed dosing for pulmonary tuberculosis
Official title: DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Run by Karolinska Institutet · NCT06585358 · Data updated 2026-11-12
This project will test whether using model-informed precision dosing (MIPD) early in treatment helps clinicians get TB drug levels into the right range for adults with pulmonary tuberculosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Linköping and 1 other locations) |
| Status | Recruiting |
| Started | November 1, 2025 |
| Main results expected | October 2027 |
| Study ends | December 2027 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT06585358 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with confirmed pulmonary tuberculosis who are starting or on rifampin-containing treatment and can provide informed consent are ideal candidates.
✕Probably not a fit
People with only extrapulmonary TB, those who have received rifampin for more than eight weeks, those on intravenous rifampin (e.g., ICU patients), or those who already had therapeutic drug monitoring before inclusion are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will collect drug concentration samples from adults with pulmonary TB who are starting rifampin-containing therapy and provide clinicians with current dosing recommendations plus MIPD-derived dosing suggestions. The team will record the time from PK sampling to dose decision (keep or adjust) and measure target attainment for rifampicin, isoniazid, pyrazinamide and ethambutol. Predicted concentrations from the pharmacokinetic models will be compared with measured concentrations to evaluate model precision. The study focuses on logistics and practical use of MIPD in routine clinical care at participating Swedish hospitals.
Why it matters
Potential benefit: If successful, MIPD could help clinicians adjust TB drug doses sooner so more patients reach effective drug levels early in treatment, potentially improving outcomes and reducing the risk of resistance.
How similar studies have gone: MIPD-like approaches have been successfully implemented for other drugs (for example vancomycin in children) and prior research shows low TB drug concentrations are common, but MIPD for TB dosing in routine clinical practice remains largely untested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Linköping University Hospital
Linköping, Sweden Recruiting -
Karolinska University Hospital
Stockholm, Sweden Recruiting
Study contacts
- Principal investigator: Lina Davies Forsman, MD, PhD — Karolinska Institutet
- Study coordinator: Lina Davies Forsman, MD, PhD, Associate Professor
- Email: lina.davies.forsman@ki.se
- Phone: 08-12370000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.