Clostridium SordelliiNCT01283828
Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
An observational study of Clostridium Sordellii and Clostridium Perfringens, run by Gynuity Health Projects at 18 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Clostridium Sordellii, Clostridium Perfringens
- How many people
- 4,977 participants
- Where
- 18 sitesUnited States
- Study dates
- Nov 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Approximately 5,000 women aged 18 to 45 years in the United States will be enrolled in the study. Women will be recruited from approximately 25 clinics and solo or group practices providing maternity care (pre- and post-natal), abortion, STI prevention \& treatment, family planning, and student health services. All women will be recruited, excluding women seeking emergency or oncological care.
Who may be able to join
- Willing and able to provide informed consent
- Between ages 18 and 45
Who cannot join
- -Seeking emergency or oncological care
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Feminist Women's Center
Atlanta, Georgia, 30329
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
Planned Parenthood of the Rocky Mountains
Boulder, Colorado, 80302
Family Planning Associates Medical Group
Chicago, Illinois, 60630
University of Cincinnati
Cincinnati, Ohio, 45267
UC Denver- Comprehensive Women's Health Center
Denver, Colorado, 80220
Red River Women's Clinic
Fargo, North Dakota, 58102
Whole Women's Health of Fort Worth
Fort Worth, Texas, 76110
Dr Barry Troyan
Houston, Texas, 77043
Dairy Ashford Family Practice
Houston, Texas, 77077
Montgomery Women's Health Associates
Montgomery, Alabama, 36117
Mt Sinai Medical Center
New York, New York, 10029
Philadelphia Women's Center
Philadelphia, Pennsylvania, 19106
Women's Health Research Center
Plainsboro, New Jersey, 08536
Downtown Gynecology
Portland, Oregon, 97205
Downtown Women's Center
Portland, Oregon, 97205
Cedar River Clinic
Seattle, Washington, 98405
University of Arizona
Tucson, Arizona, 85721
About this study
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.
Read the 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.
- Conditions
- Clostridium Sordellii, Clostridium Perfringens
- Medical subject headings
- Clostridium Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of C sordellii or C perfringens carriage in the rectum/vagina
Measured: 2 years
Secondary outcomes (2)
Duration of carriage of C sordellii or C perfringens
Measured: 2 years
Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium SordelliiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,977 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, M.D., M.P.H., Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283828
- Sponsor's protocol ID
- 7.2
- Status last verified
- Oct 2013
- First submitted
- 25 Jan 2011
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chong E, Winikoff B, Charles D, Agnew K, Prentice JL, Limbago BM, Platais I, Louie K, Jones HE, Shannon C; NCT01283828 Study Team. Vaginal and Rectal Clostridium sordellii and Clostridium perfringens Presence Among Women in the United States. Obstet Gynecol. 2016 Feb;127(2):360-8. doi: 10.1097/AOG.0000000000001239.
PubMed 26942366
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States
- ClinicalTrials.gov ID
- NCT01283828
- Acronym / sponsor ID
- 7.2
- Conditions
- Clostridium Sordellii, Clostridium Perfringens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,977 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Approximately 5,000 women aged 18 to 45 years in the United States will be enrolled in the study. Women will be recruited from approximately 25 clinics and solo or group practices providing maternity care (pre- and post-natal), abortion, STI prevention \& treatment, family planning, and student health services. All women will be recruited, excluding women seeking emergency or oncological care.
Key inclusion criteria (2 listed)
- Willing and able to provide informed consent
- Between ages 18 and 45
Key exclusion criteria (1 listed)
- -Seeking emergency or oncological care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of C sordellii or C perfringens carriage in the rectum/vagina
Time frame: 2 years
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
- Derived from this study: PubMed 26942366Chong E, Winikoff B, Charles D, Agnew K, Prentice JL, Limbago BM, Platais I, Louie K, Jones HE, Shannon C; NCT01283828 Study Team. Vaginal and Rectal Clostridium sordellii and Clostridium perfringens Presence Among Women in the United States. Obstet Gynecol. 2016 Feb;127(2):360-8. doi: 10.1097/AOG.0000000000001239.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly Winikoff, M.D., M.P.H. principal investigator
Gynuity Health Projects
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Sordellii and Clostridium Perfringens, run by Gynuity Health Projects at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of C sordellii or C perfringens carriage in the rectum/vagina (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01283828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2013.