NCT07607288Enrolling By Invitation不适用
Clinical Study on the Correlation Between Plasma Concentrations of Antituberculosis Drugs and Treatment Efficacy/Safety.
Beijing Chest Hospital1 个研究点 分布在 1 个国家目标入组 2,215 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 2,215
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Nie WenJuan
chief physician
Beijing Chest Hospital
研究点 (1)
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