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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tuberculosis; Therapeutic Drug Monitoring (TDM)
• Intervention / Treatment: Drug: Antituberculosis drugs Group

• Study Type: Observational
• Enrollment (Estimated): 2215

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 101149
      • Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Cohort; According to the patient's group of core anti-tuberculosis drugs used, record the plasma drug concentrations of each medication at 2 hours post-administration. and Collect the following information through the electronic medical record system:(1) Baseline data: age, sex, height, weight, body mass index (BMI), and albumin levels; (2) Clinical diagnostic information: Type of tuberculosis, Treatment status; (3) Treatment outcomes: cured/completed treatment, treatment failure/death, lost to follow-up; (4) Adverse drug reactions: incidence of adverse reactions, types of adverse reactions (bone marrow suppression, liver injury, kidney injury, cardiac toxicity, peripheral neurotoxicity, psychiatric/psychological adverse reactions, others), and conduct association analyses.

Drug: Antituberculosis drugs Group; Collect blood drug concentrations of various medications, such as rifampicin, isoniazid, ethambutol, and pyrazinamide.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: GCP-TB-2026-05-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No