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临床试验/NCT03209921
NCT03209921已完成不适用

Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections

Hospices Civils de Lyon0 个研究点目标入组 23 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
主要终点
Typical daptomycin clearance

研究概览

简要总结

Daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic option in patients with prosthetic joint infection caused by Staphylococcus or Enterococcus species in the latest Infectious Diseases Society of America (IDSA) guidelines.

The population pharmacokinetics (PK) of daptomycin have been described in various groups of patients in previous publications. However, little information exists on the PK of daptomycin in patients with bone and joint infections (BJI). Also, previous population studies did not investigate daptomycin PK over prolonged therapy, and, to our knowledge, no study has reported the intraindividual PK variability of this drug.

The aim of this study is to describe the inter- and intraindividual PK variability of this drug.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • patients treated with daptomycin for BJI in Lyon Center in 2012 and 2013

排除标准

  • 未提供

结局指标

主要结局

Typical daptomycin clearance

时间窗: 6 months

Mean daptomycin plasma clearance (unit, liters per hour) Outcome measures performed regularly in those patients throughout therapy, roughly every month.

Typical daptomycin volume of distribution

时间窗: 6 months

Mean daptomycin volume of distribution (unit, liters) in the population

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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