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Smart dosing could make MDR-TB treatment safer

NCT ID NCT07477119

Disease control Sponsor: Marco Schiuma Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adjusting the dose of the antibiotic linezolid based on regular blood tests can reduce harmful side effects in people being treated for multidrug-resistant tuberculosis (MDR-TB). The trial will enroll 150 patients in Guinea who are on a standard 6-month regimen called BPaL. Half will receive standard linezolid dosing, while the other half will have their dose adjusted to keep blood levels in a safe range. The goal is to see if personalized dosing lowers the risk of nerve damage and other serious side effects without reducing treatment success.

What this could mean

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

Active substance
linezolid
What this could lead to
If successful, this approach could make MDR-TB treatment safer by reducing serious side effects like nerve damage and bone marrow suppression.
What could go wrong
This is a Phase 4 study in one country (Guinea) with 150 participants. The benefit of dose personalization is not yet proven, and the method may be hard to implement in low-resource settings.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

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.

Ages

15 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\. Confirmed diagnosis of MDR-TB * 2\. Linezolid prescribed as part of the BPaL/BPaL-M regimen * 3\. Age 15 years or older * 4\. Informed consent obtained from the participant or assent from the parent/legal guardian for participants under 18 years of age. Exclusion Criteria: * 1\. Pregnancy or breastfeeding * 2\. Severe liver or kidney failure * 3\. Known hypersensitivity to linezolid * 4\. Concomitant use of medications with drug interactions potential with linezolid

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Conditions

The condition(s) this trial relates to.

Drug-Related Side Effects and Adverse Reactions multidrug-resistant tuberculosis peripheral nervous system disorder tuberculosis

As listed by the trial registrant

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

Linezolid Therapeutic drug monitoring (TDM) Tuberculosis multi drug resistant active

How to take part

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

  1. The places running it

    1 site. 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

  • Centre de Santé de Tombolia

    RECRUITING

    Conakry, Guinea

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