Collect Data From Patients Receiving Standardized Anti-tuberculosis Therapy, Collect Monitoring Data, and Evaluate Treatment Efficacy and Potential Adverse Reactions. (Tuberculosis)
2026年5月22日 更新者：Nie WenJuan、Beijing Chest Hospital
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.
研究概览
研究类型
观察性的
注册 (估计的)
2215
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing Municipality
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Beijing、Beijing Municipality、中国、101149
- Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
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.
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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Collect blood drug concentrations of various medications, such as rifampicin, isoniazid, ethambutol, and pyrazinamide.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Correlation between plasma concentrations of antituberculosis drugs and the incidence and severity of adverse events during antituberculosis treatment, particularly hepatotoxicity and cardiotoxicity.
大体时间：From January 2021 to December 2028 .
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The primary outcome
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From January 2021 to December 2028 .
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年1月1日
初级完成 (估计的)
2028年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年5月13日
首先提交符合 QC 标准的
2026年5月22日
首次发布 (实际的)
2026年5月26日
研究记录更新
最后更新发布 (实际的)
2026年5月26日
上次提交的符合 QC 标准的更新
2026年5月22日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.