Bacterial Vaginosis
Conditions
Keywords
bacterial vaginosis, tinidazole
Brief summary
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with 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.
Interventions
DRUGtinidazole, metronidazole
Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure of Bacterial Vaginosis | one month | resolution of Amsel criteria for bacterial vaginosis |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of BV | baseline to 4 weeks |
Countries
United States
Participant flow
Recruitment details
women attending a sexually transmitted disease (STD) clinic with symptomatic bacterial vaginosis (BV)
Participants by arm
| Arm | Count |
|---|---|
| Metronidazole metronidazole 500 BID for 7 days; 197 participants | 197 |
| Tinidazole 500 mg tinidazole 500 BID for 7 days; 200 particpants | 200 |
| Tinidazole 1 gm tinidazole 1 gm BID for 7 days; 196 particpants | 196 |
| Total | 593 |
Baseline characteristics
| Characteristic | Tinidazole 500 mg | Tinidazole 1 gm | Metronidazole | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 200 Participants | 196 Participants | 197 Participants | 593 Participants |
| Age, Continuous | 28.3 years STANDARD_DEVIATION 6.6 | 28.5 years STANDARD_DEVIATION 6.8 | 28 years STANDARD_DEVIATION 6.2 | 28.3 years STANDARD_DEVIATION 6.7 |
| Region of Enrollment United States | 200 participants | 196 participants | 197 participants | 593 participants |
| Sex: Female, Male Female | 200 Participants | 196 Participants | 197 Participants | 593 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 87 / 197 | 109 / 200 | 145 / 196 |
| serious Total, serious adverse events | 0 / 197 | 0 / 200 | 0 / 196 |
Outcome results
Primary
Cure of Bacterial Vaginosis
resolution of Amsel criteria for bacterial vaginosis
Time frame: one month
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metronidazole | Cure of Bacterial Vaginosis | 75 participants |
| Tinidazole 500 mg | Cure of Bacterial Vaginosis | 73 participants |
| Tinidazole 1 gm | Cure of Bacterial Vaginosis | 77 participants |
Secondary
Recurrence of BV
Time frame: baseline to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metronidazole | Recurrence of BV | 42 Participants |
| Tinidazole 500 mg | Recurrence of BV | 45 Participants |
| Tinidazole 1 gm | Recurrence of BV | 37 Participants |