Phage Safety Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- type of adverse event
研究概览
简要总结
This cohort study aims to describe the adverse events related to the use of bacteriophages to treat serious infections, data from the literature being almost non-existent on this subject.
详细描述
All potential serious adverse events in compassionate cases will be collected, and classified as potentially related to surgery, to antibiotics, or to phages, with the help of the HCL pharmacovigilance center. In addition, biobanking of pre- and post-treatment blood specimens (bloods, serums and cells) will determine whether phage immunization is implicated in particular adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy
- •Patient who did not object to participating in the study
- •Patients ayant un poids minimum de 46kg
排除标准
- •Patients under guardianship/curatorship
- •Patients deprived of liberty
- •Pregnant or breastfeeding women
结局指标
主要结局
type of adverse event
时间窗: 12 months after the injection of phages
description of the adverse event
rate of adverse event
时间窗: 12 months after the injection of phages
proportion of patient having an avderse event after injection of phages
次要结局
- biobanking PhageRESPONSE(from before the injection of phages to 6 months after the injection of phages)
- biobanking PHA SA CO(from before the injection of phages to 6 months after the injection of phages)