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临床试验/NCT01283828
NCT01283828已完成不适用

Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States

Gynuity Health Projects18 个研究点 分布在 1 个国家目标入组 4,977 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
4,977
试验地点
18
主要终点
Prevalence of C sordellii or C perfringens carriage in the rectum/vagina

研究概览

简要总结

This primary goals of this study are to: estimate the prevalence of Clostridium sordellii and Clostridium perfringens carriage in the rectum and/or vagina among women of reproductive age; estimate duration of carriage of the two clostridium species; and estimate the incidence of carriage at 2 weeks after a negative test.

详细描述

Since 2000, clostridial pelvic infections have claimed the lives of at least 17 young, previously healthy women. The majority of infections detected by molecular methods were among women testing positive for Clostridium sordellii only; in 5 cases, deaths were due to Clostridium perfringens only; and in 3 cases, the women were positive for both. These deaths occurred among both non-pregnant and recently pregnant women. Clostridium has been isolated from the vagina in 4-18% of normal, health non-pregnant women, with Clostridium perfringens the most common isolate. Most studies do not differentiate the small percentage of other clostridia present in the vaginal microenvironment. The vaginal carriage rate for Clostridium sordellii remains unknown, but is probably very low, less than 1%.

The correlates of clostridial carriage are unknown, and data on the etiology and lethality of clostridial infection among women of reproductive age are insufficient to guide possible courses of safe and effective prevention. In women infected with strains of Clostridium perfringens and Clostridium sordellii that produce the lethal toxin, it is not clear whether there is an effective treatment.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Willing and able to provide informed consent
  • Between ages 18 and 45

排除标准

  • Seeking emergency or oncological care

结局指标

主要结局

Prevalence of C sordellii or C perfringens carriage in the rectum/vagina

时间窗: 2 years

次要结局

  • Duration of carriage of C sordellii or C perfringens(2 years)
  • Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test(2 years)

研究者

发起方
Gynuity Health Projects
申办方类型
Other
责任方
Sponsor

研究点 (18)

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