Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Comparison of the efficacy of Cefazolin in the treatment of Staphylococcus meti -S infective endocarditis, with that of Penicillin M, by observing the rate of death, relapse of infective endocarditis and occurence of embolic event.
研究概览
简要总结
Retrospective, regional, multicenter study (including the Annecy-Genevois Hospital Center, the Chambéry Métropole Savoie Hospital Center, and the Grenoble University Hospital Center), comparing a cohort of patients treated with Cefazolin with a cohort of patients treated with Penicillin M
详细描述
The use of Cefazolin for the treatment of infective endocarditis caused by Staphylococcus meti - S has become commonplace in France following the stockout of injectable Penicillin M, the reference treatment, which occurred during 2016.
There is currently no clinical data to prejudge the efficacy of Cefazolin in the context of high inoculum, such as in the treatment of infective endocarditis.
On the other hand, recent data have described a better tolerance profile for Cefazolin than for Penicillin M.
The objective of this study is to compare the efficacy and safety of Cefazolin with that of Penicillin M in the management of methicillin-susceptible staphylococcal endocarditis, through the analysis of two retrospective cohorts.
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
- 否
入选标准
- •Definite infective endocarditis according to Duke criteria
- •Documented SAMS or meticillin-sensitive SCN
- •Treated with Cefazolin or Penicillin M for at least 10 consecutive days
- •Treatment initiated between 01/01/2014 and 12/31/2018
排除标准
- •Patients under 18 years old
- •Patients under 18 years old.
结局指标
主要结局
Comparison of the efficacy of Cefazolin in the treatment of Staphylococcus meti -S infective endocarditis, with that of Penicillin M, by observing the rate of death, relapse of infective endocarditis and occurence of embolic event.
时间窗: Day 10 (End of antibiotic treatment according to national recommendations
The primary outcome is management failure, a composite outcome defined by the existence of at least one of the following: * Death before the end of treatment * Relapse of infective endocarditis, with the same germ, within 3 months of the end of antibiotic therapy * Occurrence of embolic event after antibiotic therapy
次要结局
- Description of clinical predictive factors of failure(10 days (during the antibiotic treatment period))
- Assessment of clinical and biological tolerance(10 days (Occurrence of adverse events during the antibiotic treatment period))
- Description of ultrasound predictive factors of failure(10 days (during the antibiotic treatment period))
- Description of microbiological predictive factors of failure(10 days (during the antibiotic treatment period))