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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI058033 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | metronidazole 500 BID for 7 days |
|
| tinidazole 500 | Active Comparator | tinidazole 500 BID for 7 days |
|
| tinidazole 1 gm | Active Comparator | tinidazole 1 gm BID for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tinidazole, metronidazole | Drug | Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure of Bacterial Vaginosis | resolution of Amsel criteria for bacterial vaginosis | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of BV | baseline to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Schwebke, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson County Department of Health STD Clinic | Birmingham | Alabama | 35294 | United States |
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women attending a sexually transmitted disease (STD) clinic with symptomatic bacterial vaginosis (BV)
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| ID | Title | Description |
|---|---|---|
| FG000 | Metronidazole | metronidazole 500 twice a day (BID) for 7 days; 197 participants |
| FG001 | Tinidazole 500 mg | tinidazole 500 BID for 7 days; 200 particpants |
| FG002 | Tinidazole 1 gm | tinidazole 1 gm BID for 7 days; 196 particpants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metronidazole | metronidazole 500 BID for 7 days; 197 participants |
| BG001 | Tinidazole 500 mg | tinidazole 500 BID for 7 days; 200 particpants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cure of Bacterial Vaginosis | resolution of Amsel criteria for bacterial vaginosis | ITT | Posted | Number | participants | one month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metronidazole | metronidazole 500 BID for 7 days; 197 participants |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vaginal candidiasis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| jane R Schwebke, MD | University of Alabama at Birmingham | 205-975-5665 | schwebke@uab.edu |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| D014011 | Tinidazole |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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|
| BG002 | Tinidazole 1 gm | tinidazole 1 gm BID for 7 days; 196 particpants |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Recurrence of BV | Posted | Count of Participants | Participants | baseline to 4 weeks |
|
|
|
| 0 |
| 197 |
| 87 |
| 197 |
| EG001 | Tinidazole 500 mg | tinidazole 500 BID for 7 days; 200 particpants | 0 | 200 | 109 | 200 |
| EG002 | Tinidazole 1 gm | tinidazole 1 gm BID for 7 days; 196 particpants | 0 | 196 | 145 | 196 |
| gastrointestinal | Gastrointestinal disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |