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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003015', 'term': 'Clostridium Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Vaginal and rectal swabs'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4977}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-04', 'studyFirstSubmitDate': '2011-01-25', 'studyFirstSubmitQcDate': '2011-01-25', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of C sordellii or C perfringens carriage in the rectum/vagina', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Duration of carriage of C sordellii or C perfringens', 'timeFrame': '2 years'}, {'measure': 'Incidence of C. sordelli or C. perfringens carriage at 2 weeks after a negative test', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Clostridium Sordellii', 'Clostridium Perfringens']}, 'referencesModule': {'references': [{'pmid': '26942366', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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%.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing and able to provide informed consent\n* Between ages 18 and 45\n\nExclusion Criteria:\n\n-Seeking emergency or oncological care'}, 'identificationModule': {'nctId': 'NCT01283828', 'briefTitle': 'Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Vaginal and Rectal Clostridial Carriage Among Women of Reproductive Age in the United States', 'orgStudyIdInfo': {'id': '7.2'}}, 'contactsLocationsModule': {'locations': [{'zip': '36117', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': "Montgomery Women's Health Associates", 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '85721', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '80302', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Planned Parenthood of the Rocky Mountains', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "UC Denver- Comprehensive Women's Health Center", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30329', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Feminist Women's Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60630', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Family Planning Associates Medical Group', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Planned Parenthood League of Massachusetts', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08536', 'city': 'Plainsboro', 'state': 'New Jersey', 'country': 'United States', 'facility': "Women's Health Research Center", 'geoPoint': {'lat': 40.33344, 'lon': -74.60043}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '58102', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': "Red River Women's Clinic", 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97205', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Downtown Gynecology', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97205', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': "Downtown Women's Center", 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19106', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Philadelphia Women's Center", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '76110', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Whole Women's Health of Fort Worth", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77043', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Dr Barry Troyan', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77077', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Dairy Ashford Family Practice', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98405', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Cedar River Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Beverly Winikoff, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}