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

NCT07607288 | Enrolling By Invitation

• 1 other identifier: GCP-TB-2026-05-04
• Study Type: observational
• Target: 2,215
• Locations: 1 country
• Sites: 1

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.

Conditions

Therapeutic Drug Monitoring (TDM); Tuberculosis

Outcome Measures

Primary Outcomes (1)

• 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 .

Study Arms (1)

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

Interventions

Antituberculosis drugs Group DRUG

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

Study Cohort

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chest Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 101149, China

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 26, 2026
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)