Treatment of Bacterial Vaginosis (BV) With Tinidazole

• ClinicalTrials.gov Identifier: NCT00334633
• Recruitment Status: Completed
• First Posted: June 8, 2006
• Results First Posted: June 23, 2011
• Last Update Posted: December 2, 2017
• Sponsor: University of Alabama at Birmingham
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Jane Schwebke, University of Alabama at Birmingham

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Bacterial Vaginosis	Drug: tinidazole, metronidazole	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 593 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Tinidazole for the Treatment of Bacterial Vaginosis
• Study Start Date: November 2004
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

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 Name: 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 Name: 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 Name: Tindamax, Flagyl

Outcome Measures

Primary Outcome Measures :

1. Cure of Bacterial Vaginosis [ Time Frame: one month ]
   resolution of Amsel criteria for bacterial vaginosis

Secondary Outcome Measures :

1. Recurrence of BV [ Time Frame: baseline to 4 weeks ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Jefferson County Department of Health STD Clinic

Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Principal Investigator: Jane Schwebke, MD; University of Alabama at Birmingham

More Information

• Responsible Party: Jane Schwebke, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00334633 History of Changes
• Other Study ID Numbers: F040329003; R01AI058033 ( U.S. NIH Grant/Contract )
• First Posted: June 8, 2006
• Results First Posted: June 23, 2011
• Last Update Posted: December 2, 2017
• Last Verified: October 2017

Keywords provided by Jane Schwebke, University of Alabama at Birmingham:

bacterial vaginosis; tinidazole

Additional relevant MeSH terms:

Vaginosis, Bacterial; Vaginal Diseases; Genital Diseases, Female; Bacterial Infections; Vaginitis; Metronidazole; Tinidazole; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antitrichomonal Agents