|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00667368 |
Purpose
The purpose of this study is to determine whether regular screening (every 2 months) and treatment for bacterial vaginosis (BV [infection of the vagina]) will reduce the number of incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4, 8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2 possible study groups: the intervention group (treatment of BV) or the control group (no BV treatment). Every 2 months, subjects will complete a home self-testing kit for screening of BV using a swab. If BV is detected by self-test, the subjects in the interventional group will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in study related procedures for up to 12 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Vaginosis |
Other: No Intervention Drug: Metronidazole |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Home Screening for Bacterial Vaginosis to Prevent STDs |
| Estimated Enrollment: | 1500 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Bi-monthly testing and treatment for BV with Metronidazole if BV is detected.
|
Drug: Metronidazole
Metronidazole 500 mg twice daily for 7 days.
|
|
No Intervention: Control
Bi-monthly testing for BV without treatment.
|
Other: No Intervention
Subjects receive no treatment.
|
Bacterial vaginosis (BV) is characterized by an imbalance in the normal vaginal bacterial flora. In the United States (US), BV is very common, and the most common cause of vaginitis, affecting approximately 1 in 10 sexually active young women. Because BV is so common, interventions targeting BV could have a tremendous public health impact. This is a phase III randomized controlled trial, in which the primary objective is to determine whether regular screening (every two months) and treatment for asymptomatic BV can reduce the one-year incidence of chlamydial and gonococcal infections, compared to a control group of women who receive regular monitoring (every two months) for BV but no treatment. The secondary study objective is to determine demographic and behavioral factors associated with the acquisition of BV, its persistence among women who are not treated for this condition, its spontaneous resolution, and its recurrence in women who are treated for this condition. This study protocol will enroll 1500 sexually active females, aged 15 - 25 years, from 6 US cities involved in the Sexually Transmitted Infections Clinical Trials Group network (Birmingham, Durham, Raleigh, Pittsburgh, Baltimore and San Francisco). To be eligible, women must have 2 or more risk factors for sexually transmitted diseases (STDs) and must have clinical evidence of asymptomatic BV at enrollment. For the purposes of this study, women with a vaginal pH>4.5 with >20 percent clue cells detected by microscopy to have asymptomatic BV. In addition, women must deny the presence of unusual or abnormal vaginal discharge or odor. Subjects will receive bi-monthly (every two months) home self-testing kits for BV using a vaginal swab. If BV is detected by self-test, the subjects in the intervention group will receive antibiotic treatment consisting of metronidazole 500mg twice daily for 7 days. Subjects will be randomized to either an intervention group (screening and treatment for BV) or a control group (monitoring for BV without treatment). Subjects in both the intervention group and the control group will complete bi-monthly (every 2 months) follow-up assessments for BV at months 2, 4, 6, 8, 10, and 12 (the final follow-up). In addition, subjects will provide sample collections for Chlamydia trachomatis and Neisseria gonorrhoeae at 4, 8, and 12 months after study entry.
Eligibility| Ages Eligible for Study: | 15 Years to 25 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Asymptomatic bacterial vaginosis (BV)
Two or more risk factors for sexually transmitted diseases (STDs):
Exclusion Criteria:
Note: Women taking antibiotics on a regular basis will be excluded because antibiotic use could affect both BV and chlamydia/gonorrhea infections.
-Self-reported currently married/partnered and living with husband/partner of over 1 year. This does not include married women who are separated.
Note: We will exclude women who are married and who are in established long term relationships because our goal is to enroll a sample of women at high-risk for sexually transmitted diseases (STDs). Although these women are at risk for STDs, they are at lower risk overall than women who are single, separated, or divorced.
Note: We will exclude persons who do not think they could avoid drinking alcohol for one week to take an antibiotic (because metronidazole plus alcohol can lead to nausea and vomiting).
Contacts and Locations| Contact: Jane Schwebke | (205) 934-5191 | schwebke@uab.edu |
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35294-0007 | |
| United States, California | |
| San Francisco Department of Public Health | Recruiting |
| San Francisco, California, United States, 94103 | |
| RTI International | Withdrawn |
| San Francisco, California, United States, 94104 | |
| United States, Maryland | |
| John Hopkins Bay View Medical Center | Not yet recruiting |
| Baltimore, Maryland, United States, 21224 | |
| United States, North Carolina | |
| University of North Carolina at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7030 | |
| Durham County Health Department | Recruiting |
| Durham, North Carolina, United States, 27701 | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
More Information
| Responsible Party: | Director ORA, HHS/NIAID/DMID |
| ClinicalTrials.gov Identifier: | NCT00667368 History of Changes |
| Other Study ID Numbers: | 05-0131 |
| Study First Received: | April 24, 2008 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board; United States: Food and Drug Administration |
|
bacterial vaginosis, women, chlamydia, gonorrhea |
|
Vaginosis, Bacterial Bacterial Infections Vaginitis Vaginal Diseases Genital Diseases, Female Metronidazole Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |