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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01283828
Enrollment
4977
Registered
2011-01-26
Start date
2010-11-30
Completion date
2013-04-30
Last updated
2013-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Perfringens, Clostridium Sordellii

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.

Interventions

None listed

Sponsors

Gynuity Health Projects
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

-Seeking emergency or oncological care

Design outcomes

Primary

MeasureTime frame
Prevalence of C sordellii or C perfringens carriage in the rectum/vagina2 years

Secondary

MeasureTime frame
Duration of carriage of C sordellii or C perfringens2 years
Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026