Actively Recruiting
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Led by Karolinska Institutet · Updated on 2025-11-21
30
Participants Needed
2
Research Sites
108 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult persons 69 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
You will not qualify if you...
- 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)
- Therapeutic drug monitoring of rifampin has already been performed (>24 h before inclusion) by clinical routine
- Study participants with extrapulmonary TB without pulmonary TB
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Linköping University Hospital
Linköping, Sweden
Actively Recruiting
2
Karolinska University Hospital
Stockholm, Sweden, 17177
Actively Recruiting
Research Team
L
Lina Davies Forsman, MD, PhD, Associate Professor
CONTACT
K
Katarina Niward, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here