Treatment of Bacterial Vaginosis

Condition(s) targeted: Bacterial Vaginosis

Intervention: metronidazole and azithromycin (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Jane Schwebke, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham

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

Official title: Therapy and Prevention for Sexually Associated Bacterial Vaginosis

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome: cure of bacterial vaginosis

Detailed description: 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:

1. 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}

2. 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}

3. 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}

Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: symptomatic bacterial vaginosis

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Exclusion Criteria:

- pregnancy, other genital infections

Jefferson County Department of Health STD Clinic, Birmingham, Alabama 35294, United States

Starting date: July 2002
Ending date: May 2005
Last updated: December 14, 2007