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临床试验/NCT04933344
NCT04933344Unknown不适用

Pharmacokinetics and Toxicodynamics of Daptomycin in Bone and Joint Infections

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 1,130 人开始时间: 2021年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,130
试验地点
1
主要终点
description of BJI/PJI

研究概览

简要总结

the aim of this study is to investigate the relationship between exposure to daptomycin and the occurrence of muscle toxicity or eosinophilic pneumonia in patients treated with daptomycin for bone and joint infection

详细描述

Daptomycin is widely used in osteoarticular infections (IOA), as an alternative to vancomycin, and recommended for this use by various learned societies including the Infectious Diseases Society of America (IDSA) in 2013.

Tolerance to daptomycin is generally favorable, with in particular better renal tolerance than vancomycin. However, two rare and potentially severe side effects have been described with this antibiotics: muscle toxicity and eosinophilic pneumonia.

研究设计

研究类型
Observational
观察模型
Case Control
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 who have had an osteoarticular infection, treated with daptomycin, with at least one blood test for daptomycin performed

排除标准

  • Patients who objected to participating in the study
  • Absence of blood dosage of daptomycin

结局指标

主要结局

description of BJI/PJI

时间窗: between 2010 and 2020

type of BJI or PJI

description of adverse event

时间窗: between 2010 and 2020

type of adverse event

description of patients

时间窗: between 2010 and 2020

comorbidites

rate of patients having had a PJI or BJI treated by daptomycin

时间窗: between 2010 and 2020

proportion of patients treated by daptomycin

rate of patients having had an adverse event

时间窗: between 2010 and 2020

proportion of patients having had an adverse event under daptomycin

Evalutation of the adverse event due to daptomycin : duration of daptomycine

时间窗: between 2010 and 2020

description of the use of daptomycine : duration

Evalutation of the adverse event due to daptomycin : daptomycine plasma clearance

时间窗: between 2010 and 2020

mean daptomycine plasma clearance (unit, liters per hour)

Evalutation of the adverse event due to daptomycin : daptomycine volume distribution

时间窗: between 2010 and 2020

mean daptomycine volume of distribution (unit, liters)

Evalutation of the adverse event due to daptomycin : dosage of daptomycine

时间窗: between 2010 and 2020

description of the use of daptomycine : dosage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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