Treatment of Bacterial Vaginosis (BV) With Tinidazole

Tinidazole for the Treatment of Bacterial Vaginosis

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

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: tinidazole, metronidazole

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 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 Type: Interventional
• Enrollment (Actual): 593
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women be at least 18 years of age
• Have symptoms of vaginal odor and or/discharge
• Meet the clinical (Amsel) criteria for BV
• Willing to participate in research

Exclusion Criteria:

• Presence of another vaginal infection or STD
• Allergy to metronidazole
• Pregnant or nursing
• Use of oral or intravaginal antibiotics within the past 2 weeks
• HIV or other chronic disease
• Inability to keep return appointments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; metronidazole 500 BID for 7 days	Drug: tinidazole, metronidazole; Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid; Other Names: Tindamax, Flagyl
Active Comparator: tinidazole 500; tinidazole 500 BID for 7 days	Drug: tinidazole, metronidazole; Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid; Other Names: Tindamax, Flagyl
Active Comparator: tinidazole 1 gm; tinidazole 1 gm BID for 7 days	Drug: tinidazole, metronidazole; Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid; Other Names: Tindamax, Flagyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure of Bacterial Vaginosis	resolution of Amsel criteria for bacterial vaginosis	one month

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrence of BV	baseline to 4 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Jane Schwebke, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 7, 2006
• First Submitted That Met QC Criteria: June 7, 2006
• First Posted (Estimate): June 8, 2006

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: bacterial vaginosis; tinidazole
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Alkylating Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antitrichomonal Agents; Metronidazole; Tinidazole
• Other Study ID Numbers: F040329003; R01AI058033 (U.S. NIH Grant/Contract)