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TB dosing gets a custom fit: new study tests precision medicine

NCT ID NCT06585358

Knowledge-focused Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether using computer models to personalize tuberculosis (TB) drug doses can help patients reach optimal drug levels faster. Researchers will monitor 30 adults with pulmonary TB who are already on standard treatment. The goal is to see if this approach helps doctors adjust doses quickly and accurately, potentially improving treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
model-informed precision dosing (MIPD) for rifampicin, isoniazid, pyrazinamide, and ethambutol
What this could lead to
If successful, this could help doctors personalize TB drug doses for each patient, potentially improving treatment effectiveness and reducing side effects.
What could go wrong
This is a small, early observational study (30 people) that only tests whether the dosing method works in practice, not whether it improves cure rates. It may not lead to better outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The inclusion of study participants will be done prospectively at two hospitals included in the study sites (Karolinska University Hospital and Region Östergötland). Only patients with pulmonary TB will be included as the MIPD models have been developed using data sets of pulmonary TB and not for extrapulmonary TB. Participants who are unable to give an informed consent (e.g. persons with severe dementia) will not be included. The investigators will include at least 30 participants. Blood samples for drug concentration analysis will be performed 2+4 hours postdose at 2 -3 occasions during the study period and measure by a validated HPLC method at Clinical Pharmacology Laboratories in the regions.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberculosis, pulmonary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Karolinska University Hospital

    RECRUITING

    Stockholm, 17177, Sweden

  • Linköping University Hospital

    RECRUITING

    Linköping, Sweden

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