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

NCT06585358 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-11-21

No results posted yet for this study

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.

Conditions

  • Tuberculosis, Pulmonary

Interventions

OTHER

MIPD

This is a non-inverventional study

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Region Östergötland

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Lina Davies Forsman, MD, PhD · Karolinska Institutet

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • Sweden

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06585358 on ClinicalTrials.gov