Phage Safety Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- rate of patients having had an adverse event
研究概览
简要总结
The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients having had a bone or joint or implant infection treated by phagotherapy and having had an adverse event
排除标准
- 未提供
结局指标
主要结局
rate of patients having had an adverse event
时间窗: 1 year
number of patients having had an adverse event
rate of adverse event attributable to the surgery
时间窗: 1 year
number of patients having had an adverse event because of the surgery
type of adverse event attributable to the surgery
时间窗: 1 year
classification according to Clavien's Clasification
rate of adverse event attributable to the antibiotic treatment
时间窗: 1 year
number of patients having had an adverse event because of the antibiotic treatment
rate of adverse event attributable to the phagotherapy
时间窗: 1 year
number of patients having had an adverse event because of phagotherapy
次要结局
未报告次要终点