Status:
RECRUITING
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Karolinska University Hospital
Region Östergötland
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
18+ years
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...
Detailed Description
Background: Individualised treatment for tuberculosis (TB) to improve treatment outcome has still some substantial obstacles to pass before becoming a reality in clinical practice. Previous studies, ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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 criteria
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06585358
Start Date
November 1 2025
End Date
December 1 2027
Last Update
November 21 2025
Active Locations (2)
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1
Linköping University Hospital
Linköping, Sweden
2
Karolinska University Hospital
Stockholm, Sweden, 17177