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| Sponsor: | University of Alabama at Birmingham |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | University of Alabama at Birmingham |
| ClinicalTrials.gov Identifier: | NCT00324818 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study |
| Official Title: | Therapy and Prevention for Sexually Associated 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:
{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:
Exclusion Criteria:
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
| Study ID Numbers: | R01AI048044 |
| Study First Received: | May 9, 2006 |
| Last Updated: | November 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00324818 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
bacterial vaginosis treatment |
|
Bacterial Infections Metronidazole Anti-Infective Agents Antiprotozoal Agents Vaginitis Physiological Effects of Drugs Vaginal Diseases Pharmacologic Actions |
Genital Diseases, Female Anti-Bacterial Agents Antiparasitic Agents Vaginosis, Bacterial Radiation-Sensitizing Agents Azithromycin Therapeutic Uses |