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Treatment of BV With Tinidazole

2014-07-23 21:43:34 | BioPortfolio

Summary

We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole

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 as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Although not currently licensed in the U.S., tinidazole is an antimicrobial related to metronidazole which has shown promise for the treatment of BV in European studies and is widely used worldwide for the treatment of trichomoniasis including infections which are resistant to metronidazole. We hypothesize that qualities of tinidazole such as its longer half-life and its seemingly superior side effect profile as compared to oral metronidazole will result in its being a more efficacious drug for the treatment of BV than the currently available options.

The specific aims of this project are:

1. To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates

2. To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV

3. To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Bacterial Vaginosis

Intervention

tinidazole

Location

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

Status

Recruiting

Source

University of Alabama at Birmingham

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:43:34-0400

Clinical Trials [308 Associated Clinical Trials listed on BioPortfolio]

Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps...

Treatment of Bacterial Vaginosis With Oral Tinidazole

The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.

A Pilot Study of Oral Tinidazole for Women With Recurrent Bacterial Vaginosis

This is a study of the drug tinidazole for women with recurrent bacterial vaginosis. Half of the participants will get the drug for 10 days, the other half will get the drug for 10 days an...

Bacterial Vaginosis Carriage in Early Pregnancy and Preterm Delivery in Martinique, F.W.I

Preterm delivery is a public health priority in Martinique, a French oversees territory located in the Caribbean, with a rate of 10,5% substantially higher than in Continental France (7,5%...

Effect of Bacterial Vaginosis on HIV Susceptibility and Female Genital Immunology

A non-randomized, interventional, longitudinal clinical study to quantify the impact of bacterial vaginosis treatment on HIV susceptibility and genital immunology in Kenyan women.

PubMed Articles [3540 Associated PubMed Articles listed on BioPortfolio]

Protein Content of Cervicovaginal Fluid Is Altered During Bacterial Vaginosis.

The aim of the study was to compare, using a proteomic approach, cervicovaginal fluid (CVF) proteins of women with bacterial vaginosis (BV) with those presenting normal microbiota.

Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: Acceptability, tolerability and impact on the genital microbiota of couples - A pilot study.

Recurrence following recommended treatment for bacterial vaginosis is unacceptably high. While the pathogenesis of recurrence is not well understood, recent evidence indicates re-infection from sexual...

Prevalence of sexually transmitted infections and bacterial vaginosis among women in sub-Saharan Africa: An individual participant data meta-analysis of 18 HIV prevention studies.

Estimates of sexually transmitted infection (STI) prevalence are essential for efforts to prevent and control STIs. Few large STI prevalence studies exist, especially for low- and middle-income countr...

Novel antihelmintic activity of tinidazole coordination compounds. Relevance of the metal ion and structural properties.

The in vitro and in vivo antihelmintic activity of cobalt(II), copper(II) and zinc(II) coordination compounds of tinidazole (tnz) were investigated in cultivated spotted rose snapper, infested with da...

Probiotics for vulvovaginal candidiasis in non-pregnant women.

Vulvovaginal candidiasis (VVC) is estimated to be the second most common form of infection after bacterial vaginosis. The ability of probiotics in maintaining and recovering the normal vaginal microbi...

Medical and Biotech [MESH] Definitions

A genus of bacteria found in the human genital and urinary tract. It is considered to be a major cause of bacterial vaginosis (VAGINOSIS, BACTERIAL).

The only species in the genus GARDNERELLA, and previously classed as Haemophilus vaginalis. This bacterium, also isolated from the female genital tract of healthy women, is implicated in the cause of bacterial vaginosis (VAGINOSIS, BACTERIAL). It occasionally causes postpartum bacteremia and bacteremia following a transurethral resection of the prostate.

A genus of gram-negative, anaerobic, rod-shaped bacteria. Its organisms are found in the human vagina, particularly in association with Gardnerella vaginalis in cases of bacterial vaginosis.

A species of Lactobacillus that occurs in the human GASTROINTESTINAL TRACT and the VAGINA of healthy women. It produces LACTIC ACID and HYDROGEN PEROXIDE, and is used as a PROBIOTIC. It is also used for the treatment and prevention of BACTERIAL VAGINOSIS.

Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli.

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