Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole
Tulane University
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.
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. vaginali…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 (ei…
Interventions
- DrugMetronidazole 500 mg
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
Locations (4)
- University of Alabama at Birmingham [UAB] Gynecology ClinicsBirmingham, Alabama
- UAB Sexual Health Research Clinic [SHRC]Birmingham, Alabama
- Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161North Miami, Florida
- LSU-CrescentCare Sexual Health CenterNew Orleans, Louisiana