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临床试验/NCT07607288
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

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

发起方
Beijing Chest Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nie WenJuan

chief physician

Beijing Chest Hospital

研究点 (1)

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