跳至主要内容
临床试验/NCT02440438
NCT02440438已完成不适用

Factors Associated With Relapses in Patients Suffering From Clostridium Difficile Infection: Immune Response

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2014年1月1日最近更新:
适应症
干预措施

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

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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