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DoseTB-individualised Dosing by Model-informed Precision Dosing for Pulmonary Tuberculosis

Recruitingn/aAges 18 Years - anyAllKarolinska Institutet
NCT06585358 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 concentr

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📋 Eligibility rules (as published)
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.
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What it tests

  • MIPD
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Where

2 sites
Linköping University Hospital
Linköping, Sweden
Karolinska University Hospital
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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