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

Completed

• Conditions: Clostridium Sordellii; Clostridium Perfringens

• Registration Number: NCT01283828
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-04
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4977

Inclusion Criteria

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

Exclusion Criteria

-Seeking emergency or oncological care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of C sordellii or C perfringens carriage in the rectum/vagina	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

Montgomery Women's Health Associates; 🇺🇸 Montgomery, Alabama, United States

University of Arizona; 🇺🇸 Tucson, Arizona, United States

Planned Parenthood of the Rocky Mountains; 🇺🇸 Boulder, Colorado, United States

UC Denver- Comprehensive Women's Health Center; 🇺🇸 Denver, Colorado, United States

Feminist Women's Center; 🇺🇸 Atlanta, Georgia, United States

Family Planning Associates Medical Group; 🇺🇸 Chicago, Illinois, United States

Planned Parenthood League of Massachusetts; 🇺🇸 Boston, Massachusetts, United States

Women's Health Research Center; 🇺🇸 Plainsboro, New Jersey, United States

Mt Sinai Medical Center; 🇺🇸 New York, New York, United States

Red River Women's Clinic; 🇺🇸 Fargo, North Dakota, United States

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