Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- immune response rate
研究概览
简要总结
Clostridium difficile is responsible for up to 25% of reported antibiotic associated diarrhea cases and virtually all cases of pseudomembranous colitis (PMC). The clinical spectrum of C. difficile infection (CDI) varies in severity from asymptomatic carriage to self-limited, mild, watery diarrhea, to PMC, intestinal perforation, toxic megacolon, sepsis, fulminant colitis, and death. In the past decade, the 027/NAP1/BI strain has emerged world-wide and has been implicated in large outbreaks with increased severity, frequent recurrence, and significant mortality. The host immune responses can influence the severity of CDI and play crucial roles in CDI onset, progression, and overall prognosis. Low serum concentrations of antibodies directed against the toxins A&B of C. difficile have been associated with a higher risk of recurrence. However, there are conflicting reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Hospitalized
- •Suffering from diarrhea related to C. difficile
- •Confirmed diagnosis of CDI
- •Informed consent by the patient
- •Affiliated to the social security regime
排除标准
- •Out-patient
- •No confirmed diagnosis of CDI
- •Decline of participation
- •Patient not affiliated to the social security regime
研究组 & 干预措施
Clostridium difficile infection
干预措施: Blood sampling (Biological)
结局指标
主要结局
immune response rate
时间窗: up to 60 days after diagnosis
次要结局
未报告次要终点
