NCT06585358 DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
| NCT ID | NCT06585358 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Tuberculosis, Pulmonary |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-11-01 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Lina Davies Forsman, MD, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06585358 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tuberculosis, Pulmonary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06585358 currently recruiting?
Yes, NCT06585358 is actively recruiting participants. Contact the research team at lina.davies.forsman@ki.se for enrollment information.
Where is the NCT06585358 trial being conducted?
This trial is being conducted at Linköping, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT06585358 clinical trial?
NCT06585358 is sponsored by Karolinska Institutet. The principal investigator is Lina Davies Forsman, MD, PhD at Karolinska Institutet. The trial plans to enroll 30 participants.