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临床试验/NCT04414137
NCT04414137Unknown不适用

Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution

研究概览

简要总结

Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.

Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide.

The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future

详细描述

Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria.

The Infectious Diseases Society of America recommends the use of daptomycin 6 mg / kg / day in the second-line treatment of IOA on staphylococcal but also enterococcal prostheses, as an alternative to vancomycin and linezolid.

In case of renal failure, daptomycin is often considered as a good therapeutic alternative to glycopeptides.

Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide. Although a large proportion of cases have been reported in patients receiving daptomycin in unapproved indications, the use of daptomycin in authorized indications has also been associated with this risk.

The dosage of daptomycin makes it possible to evaluate its effectiveness and prevent the occurrence of a overdose, provider of side effects.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients having had an eosinophilic pneumonia under daptomycine given to treat an osteoarticular infection (BJI/PJI)

排除标准

  • 未提供

结局指标

主要结局

Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine volume distribution

时间窗: 6 months

mean daptomycine volume of distribution (unit, liters)

Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: duration of daptomycine

时间窗: 6 months

description of the use of daptomycine : duration

Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: daptomycine plasma clearance

时间窗: 6 months

mean daptomycine plasma clearance (unit, liters per hour)

description of BJI/BJI in patients having eosinophilic pneumonia due to daptomycin

时间窗: 2 months

description of the BJI/PJI (symptoms, type of evolution, type of implant)

description patients having eosinophilic pneumonia due to daptomycin

时间窗: 2 months

description of the patients (average age, medical background)

rate of eosinophilic pneumonia due to daptomycin in osteoarticular infection: the adverse event

时间窗: 6 months

number of cases and description of the adverse event as assessed by CTCAE v4.0

Evalutation of eosinophilic pneumonia due to daptomycin in osteoarticular infection: dosage of daptomycine

时间窗: 6 months

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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