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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
| Louisiana State University Health Sciences Center in New Orleans | OTHER |
| Healthcare Clinical Data | UNKNOWN |
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This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men.
This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men. The goal is to refine T. vaginalis treatment for women and men by examining the effectiveness (Aim 1) and cost-effectiveness (Aim 2) of multi-dose oral MTZ versus single-dose oral SEC. The investigators have several secondary analyses for Aim 1 including to examine if bacterial vaginosis (BV) interferes with T. vaginalis treatment, to explore preferences for follow-up visits, and to examine the natural history of T. vaginalis infection in both sexes.
If single-dose oral SEC is found to be superior to multi-dose oral MTZ, this could potentially result in an estimated 280,000 people in the U.S./year receiving better care, having fewer adverse sexual and reproductive health outcomes, and having a reduced risk for HIV acquisition. It will also provide patients with a single-dose oral treatment option that will be particularly attractive for subjects with concomitant T. vaginalis and BV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Multi-Dose Metronidazole | Experimental | Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men |
|
| Single-Dose Secnidazole | Experimental | Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole 500 mg | Drug | Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure. | A repeat T. vaginalis NAAT test will be completed at the test of cure (TOC) visit | A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To examine if BV co-infection interferes with T. vaginalis treatment | Of those who test positive for BV via BV OSOM at baseline, those who re-test positive via BV OSOM at one-month test-of-cure will be compared by treatment arm. | From enrollment to completion of one-month test of cure for those who test BV positive at baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Kissinger, PhD | Contact | 504-988-7320 | kissing@tulune.edu | |
| Christina Muzny, MD | Contact | 205-975-3298 | cmuzny@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Kissinger, PhD | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham [UAB] Gynecology Clinics | Recruiting | Birmingham | Alabama | 25233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42031495 | Derived | Muzny CA, Lillis RA, Chavoustie SE, Arbuckle JL, Van Gerwen OT, Sagoe M, Kandregula AR, Srivastav S, Kissinger PJ. Refining Trichomonas vaginalis treatment in women and men: protocol for an open-label randomised comparison of multi-dose oral metronidazole versus single-dose oral secnidazole. BMJ Open. 2026 Apr 24;16(4):e116003. doi: 10.1136/bmjopen-2025-116003. |
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|
| Secnidazole 2000 MG | Drug | Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men |
|
|
| To examine if oral single-dose secnidazole is superior to oral multi-dose metronidazole for the treatment of BV. |
We will conduct a secondary analysis to compare the effectiveness of oral single-dose secnidazole versus oral multi-dose metronidazole among women enrolled in the trial with a diagnosis of BV at baseline. Those who test positive for BV via BV OSOM at baseline will be re-tested and BV positivity at one-month will be compared by treatment arm. |
| From baseline visit to one-month test of cure visit |
| A comparison of participant preferences for the test-of-cure (TOC) visit (in clinic versus telemedicine) as captured on baseline survey. | Participants will be asked their preference for an in person one-month test of cure visit that is in person versus telehealth. | From baseline visit to one-month test of cure visit |
| A comparison of TV NAAT confirmatory test results to determine the percentage who spontaneously clear the infection without medication. | Women and men who previously tested positive for T. vaginalis by nucleic acid amplification test (NAAT) will be retested by NAAT at study entry. The rate of early spontaneous resolution will be calculated. | at baseline, we document their prior test result (per medical records, survey or onsite testing). |
| UAB Sexual Health Research Clinic [SHRC] | Recruiting | Birmingham | Alabama | 35205 | United States |
|
| Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161 | Not yet recruiting | North Miami | Florida | 33161 | United States |
|
| LSU-CrescentCare Sexual Health Center | Recruiting | New Orleans | Louisiana | 70119 | United States |
|
| ID | Term |
|---|---|
| D014247 | Trichomonas Vaginitis |
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D014245 | Trichomonas Infections |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| C016724 | secnidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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