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Blood tests could personalize TB dosing to boost success and cut harm

NCT ID NCT07607288

Knowledge-focused Sponsor: Beijing Chest Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 times

Summary

This study is tracking over 2,200 tuberculosis patients to see how the amount of TB drugs in their blood relates to how well the treatment works and whether they have side effects. By measuring drug levels, researchers hope to find ways to adjust doses for each person, especially those with other health issues or hard-to-treat TB. The goal is to make treatment safer and more effective, but this is an observational study, not a test of a new medicine.

What this could mean

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

Active substance
antituberculosis drugs (rifampicin, isoniazid, ethambutol, pyrazinamide)
What this could lead to
If successful, this could help doctors adjust TB drug doses for each patient, improving treatment effectiveness and reducing side effects like liver or heart damage.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test a new drug or cure. Results may not apply to all TB patients, and individual dose adjustments still need further validation.

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 2,215 people

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

Started

Jan 2021

Expected to finish

Dec 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.

Who is studied

This study is a multicenter, observational clinical study conducted from January 2021 to December 2024 at Beijing Chest Hospital Affiliated to Capital Medical University and Xi'an Eighth Hospital. Tuberculosis patients receiving either initial or relapsed treatment were enrolled and administered standardized anti-tuberculosis regimens. Intravenous blood samples were collected 2 hours after medication administration at weeks 2, 4, 8, 12,16,20, and 24 of treatment. Plasma concentrations of anti-tuberculosis drugs were determined using high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). The collection time, dosing interval, blood sampling time point, and tested drug types were recorded. Invalid samples with non-standard sampling procedures or missing data were excluded.

Ages

5 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: * Patients with tuberculosis confirmed by bacteriological or pathological diagnosis; * Those who have received standardized anti-tuberculosis treatment regimens; * Patients with complete clinical records and completed follow-up for at least one treatment course. Exclusion Criteria: * Baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels\>2 times the upper limit of normal; * Concurrent chronic liver diseases such as chronic hepatitis B, hepatitis C, or alcoholic liver disease; * Concurrent severe underlying cardiac conditions (e.g.,congenital heart disease, cardiomyopathy, severe arrhythmias); * Concurrent use of multiple medications that may affect cardiac function; * Human immunodeficiency virus (HIV) co-infection; * Women who are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

tuberculosis

As listed by the trial registrant

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

Therapeutic drug monitoring (TDM) Tuberculosis

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute

    Beijing, Beijing Municipality, 101149, China

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