Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions.
Enrolling by invitation
Conditions studied: Therapeutic Drug Monitoring (TDM), Tuberculosis
In brief
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.
Key facts
- Study ID
- NCT07607288
- Run by
- Beijing Chest Hospital
- People needed
- 2215
- Starts
- 2021-01-01
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2026-05-26
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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