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临床试验/NCT04724798
NCT04724798Unknown不适用

Population Pharmacokinetics of Tigecycline in Patients Treated With ECMO

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
10
试验地点
1
主要终点
Serum drug concentration of tigecycline

研究概览

简要总结

Tigecycline is a commonly used antibiotic in critically ill patients. The pharmacokinetics (PK) of tigecycline in intensive care unit (ICU) patients can be affected by severe pathophysiological changes so that standard dosing might not be adequate. At present, a number of studies have reported that ECMO will affect the PK of anti-infective drugs and lead to treatment failure. The purpose of this study was to describe the population PK of tigecycline in patients treated with ECMO and to evaluate the relationship between individual PK parameters and patient covariates.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • critically ill hospitalized males or nonpregnant females aged ≥18 years with severe infections which the treating clinician was treating with tigecycline.

排除标准

  • People who had taken tigecycline in the past week
  • People who were pregnant
  • People who had coagulation dysfunction

结局指标

主要结局

Serum drug concentration of tigecycline

时间窗: predose, 2 min, 5 min, 15 min, 30 min, 1 hour, 3 hours, 6 hours, 12 hours, and 24 hours post-dose

Serum drug concentration at different time points in each adult ICU patient treated with ECMO

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhenhua Zen

Associate Professor

Nanfang Hospital, Southern Medical University

研究点 (1)

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