Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antituberculosis drugs Group.
- Who it may be relevant to
- Registry conditions: Therapeutic Drug Monitoring (TDM), Tuberculosis. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study on the Correlation Between Plasma Concentrations of Antituberculosis Drugs and Treatment Efficacy/Safety.
Overview
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
- Drug Antituberculosis drugs Group
Collect blood drug concentrations of various medications, such as rifampicin, isoniazid, ethambutol, and pyrazinamide.
Primary outcome measures
- 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 .]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Th — Beijing
Identifiers
NCT: NCT07607288 · GCP-TB-2026-05-04