Trichomonas Vaginitis, Bacterial Vaginitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men
DRUGSecnidazole 2000 MG
Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men
Sponsors
Tulane University
University of Alabama at Birmingham
Louisiana State University Health Sciences Center in New Orleans
Healthcare Clinical Data
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women and men aged 18 years or older of any race/ethnicity will be included in the study. * Participants must have either a positive T. vaginalis rapid antigen test (OSOM), or wet mount microscopy with motile trichomonads, or nucleic acid amplification test (NAAT) urinalysis or Pap smear positive for TV within two weeks of available results (and have not yet been treated) that is confirmed by repeat T. vaginalis NAAT testing at study enrollment, * Willing and able to provide and understand informed consent to comply with the study protocol, * Have a method of contact (either phone, email or social media), * Be willing to be randomized.
Exclusion criteria
* Pregnant/lactating or seeking to be pregnant * Have been treated for with a 5-nitroimidazole (i.e. Metronidazole (MTZ), tinidazole (TDZ), or secnidazole \[SEC\]) in the last 28 days * Used intravaginal boric acid or any other intravaginal treatment for T. vaginalis in the last 14 days * Have a history of a type 1 hypersensitivity reaction to 5-nitroimidazole medications * Are taking phenytoin (Dilantin) and/or warfarin (Coumadin) due to drug-drug interactions with oral MTZ * Use of medications which may alter the metabolism of MTZ including Lithium and barbiturates (amobarbital, butalbital, methohexital, phenobarbital, pentobarbital, primidone, secobarbital) * Have been previously enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure. | A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment | A repeat T. vaginalis NAAT test will be completed at the test of cure (TOC) visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To examine if BV co-infection interferes with T. vaginalis treatment | From enrollment to completion of one-month test of cure for those who test BV positive at baseline. | 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. |
| To examine if oral single-dose secnidazole is superior to oral multi-dose metronidazole for the treatment of BV. | From baseline visit to one-month test of cure visit | 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. |
| A comparison of participant preferences for the test-of-cure (TOC) visit (in clinic versus telemedicine) as captured on baseline survey. | From baseline visit to one-month test of cure visit | Participants will be asked their preference for an in person one-month test of cure visit that is in person versus telehealth. |
| A comparison of TV NAAT confirmatory test results to determine the percentage who spontaneously clear the infection without medication. | at baseline, we document their prior test result (per medical records, survey or onsite testing). | 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. |
Countries
United States
Contacts
CONTACTPatricia Kissinger, PhD
CONTACTChristina Muzny, MD
PRINCIPAL_INVESTIGATORPatricia Kissinger, PhD
Tulane University
Outcome results
None listed