Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 3:30 AM
Study NCT ID:
NCT01283828
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2011-01-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
Sponsor:
Gynuity Health Projects
Organization:
Study Overview
Official Title:
Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: