Treatment of Bacterial Vaginosis (BV) With Tinidazole

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Bacterial Vaginosis

Treatments: Drug: tinidazole, metronidazole

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00334633

F040329003

R01AI058033 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 593 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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593 participants in 3 patient groups

control

Active Comparator group

Description:

metronidazole 500 BID for 7 days

Treatment:

Drug: tinidazole, metronidazole

tinidazole 500

Active Comparator group

Description:

tinidazole 500 BID for 7 days

Treatment:

Drug: tinidazole, metronidazole

tinidazole 1 gm

Active Comparator group

Description:

tinidazole 1 gm BID for 7 days

Treatment:

Drug: tinidazole, metronidazole