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

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.

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Key information

Conditions

Therapeutic Drug Monitoring (TDM) Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, Beijing Municipality, 101149, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antituberculosis drugs Group

Drug

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

Primary outcomes

Correlation between plasma concentrations of antituberculosis drugs and the incidence and severity of adverse events during antituberculosis treatment, particularly hepatotoxicity and cardiotoxicity.

Time frame: From January 2021 to December 2028 .

The primary outcome

Sponsors and collaborators

Lead sponsor

Beijing Chest Hospital

Other

Registry information

Official study title

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

Acronym: Tuberculosis

Important dates

Study start: 2021
Primary completion: 2028
Study completion: 2028
First posted: May 26, 2026
Registry last updated: May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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