Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
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|ClinicalTrials.gov Identifier: NCT01283828|
Recruitment Status : Completed
First Posted : January 26, 2011
Last Update Posted : October 7, 2013
|Condition or disease|
|Clostridium Sordellii Clostridium Perfringens|
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.
|Study Type :||Observational|
|Actual Enrollment :||4977 participants|
|Official Title:||Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
- Prevalence of C sordellii or C perfringens carriage in the rectum/vagina [ Time Frame: 2 years ]
- Duration of carriage of C sordellii or C perfringens [ Time Frame: 2 years ]
- Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283828
|Principal Investigator:||Beverly Winikoff, M.D., M.P.H.||Gynuity Health Projects|