Treatment of Bacterial Vaginosis
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Purpose
We are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for BV
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Vaginosis |
Drug: metronidazole and azithromycin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Therapy and Prevention for Sexually Associated Bacterial Vaginosis |
- cure of bacterial vaginosis
| Estimated Enrollment: | 600 |
| Study Start Date: | July 2002 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U.S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated for decreasing the prevalence of these complications. The etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Further, half of all women who meet the clinical diagnostic criteria for BV are asymptomatic and treatment of these women remains controversial. More detailed characterization of the origins, natural history and response to therapy would supply data to guide control efforts. We will approach these problems through a multifaceted interdisciplinary evaluation of women with and without BV.
The specific aims {and hypotheses} of this project are:
- To conduct studies to determine optimal agents and duration of therapy for BV {Hypothesis: Longer duration of therapy and combination therapy will result in higher cure rates and lower recurrence rates of BV; response to therapy differs between women with asymptomatic BV and symptomatic BV}
- To examine the role of condoms in the prevention of BV {Hypothesis: BV is a sexually transmitted infection, thus recurrence rates of BV will be lower among women with higher condom usage rates}
- To further explore the role of Mobiluncus spp., organisms strongly associated with the syndrome, by utilizing specimens derived from the above studies.
{Hypothesis: Mobiluncus is involved in the pathogenesis of BV at least in a subset of women, and the persistence of this organism is associated with lack of cure and recurrence of BV}
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Symptomatic bacterial vaginosis
Exclusion Criteria:
- Pregnancy
- Other genital infections
Contacts and Locations| United States, Alabama | |
| Jefferson County Department of Health STD Clinic | |
| Birmingham, Alabama, United States, 35294 | |
| Principal Investigator: | Jane Schwebke, MD | University of Alabama at Birmingham |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00324818 History of Changes |
| Other Study ID Numbers: | R01AI048044 |
| Study First Received: | May 9, 2006 |
| Last Updated: | November 13, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Alabama at Birmingham:
|
bacterial vaginosis treatment |
Additional relevant MeSH terms:
|
Vaginosis, Bacterial Bacterial Infections Vaginitis Vaginal Diseases Genital Diseases, Female Metronidazole Azithromycin Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 16, 2013