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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 45
Updated:10/19/2013
Start Date:November 2010
End Date:April 2013
Contact:Erica Chong, M.P.H
Email:echong@gynuity.org
Phone:212-448-1230

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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.


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.

Inclusion Criteria:

- Willing and able to provide informed consent

- Between ages 18 and 45

Exclusion Criteria:

-Seeking emergency or oncological care
We found this trial at
18
sites
Plainsboro, New Jersey 08536
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Atlanta, Georgia 30329
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Atlanta, GA
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Boston, Massachusetts 02215
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Boston, MA
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Chicago, IL
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cincinnati, OH
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Denver, CO
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Fargo, North Dakota 58102
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Fargo, ND
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Fort Worth, Texas 76110
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Fort Worth, TX
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Houston, Texas 77043
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Houston, TX
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Houston, Texas 77077
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Houston, TX
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Montgomery, Alabama 36117
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Montgomery, AL
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New York, New York 10029
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New York, NY
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Philadelphia, Pennsylvania 19106
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Philadelphia, PA
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Portland, Oregon 97205
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Portland, OR
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Portland, Oregon 97205
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Portland, OR
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Seattle, Washington 98405
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Seattle, WA
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Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
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Tucson, AZ
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