Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions.
Antituberculosis drugs Group: Collect blood drug concentrations of various medications, such as rifampicin, isoniazid, ethambutol, and pyrazinamide.
Study 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.
Eligibility
Sex
ALL
Min age
5 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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