Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions.

Clinical Study on the Correlation Between Plasma Concentrations of Antituberculosis Drugs and Treatment Efficacy/Safety.

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07607288

Acronym

Tuberculosis

Enrollment

2215

Registered

2026-05-26

Start date

2021-01-01

Completion date

2028-12-31

Last updated

2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Therapeutic Drug Monitoring (TDM), Tuberculosis

Brief summary

The purpose of this clinical trial is to investigate the correlation between anti-tuberculosis drug concentration monitoring and treatment efficacy and safety through analytical studies.The main questions it aims to answer include: Guidance for individualized dosage adjustment of anti-tuberculosis drugs; Guidance on medication challenges for special populations and patients with comorbidities;Address the dose optimization issue for refractory tuberculosis.

Interventions

DRUGAntituberculosis drugs Group

Collect blood drug concentrations of various medications, such as rifampicin, isoniazid, ethambutol, and pyrazinamide.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Correlation between plasma concentrations of antituberculosis drugs and the incidence and severity of adverse events during antituberculosis treatment, particularly hepatotoxicity and cardiotoxicity.	From January 2021 to December 2028 .	The primary outcome

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026