Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole

Trichomonas Vaginitis Clinical Trial

Official title:

Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261840
• Other study ID #: 2024-101
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: July 31, 2029

Study information

• Verified date: February 2024
• Source: Tulane University
• Contact: Patricia Kissinger, PhD
• Phone: 504-988-7320
• Email: kissing[@]tulune.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. Our 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. We 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: July 31, 2029
• Est. primary completion date: May 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must have a positive T. vaginalis rapid antigen test, wet mount, or nucleic acid amplification test (NAAT) within two weeks of available results (and have not yet been treated) that is confirmed by repeat T. vaginalis NAAT testing at study enrollment, must speak and understand English and be willing to comply with the study protocol, have a method of contact (either phone, email or social media), and be willing to be randomized.

Exclusion Criteria:

• Participants will be excluded if they are pregnant/lactating, have been treated for their trichomonas infection with 5-nitroimidazoles (i.e. MTZ, SEC), used intravaginal boric acid or any other intravaginal treatment for T. vaginalis in the last 28 days, or if they have a history of a hypersensitivity reaction to 5-nitroimidazole medications. They also cannot be taking phenytoin (Dilantin) and/or warfarin (Coumadin) due to drug interactions with oral MTZ or have been previously enrolled in the study.

Related Conditions & MeSH terms

• Trichomonas Infections
• Trichomonas Vaginitis
• Vaginitis

Intervention

Drug:
• Metronidazole 500 mg
Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men
• Secnidazole 2000 MG
Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Tulane University	Louisiana State University Health Sciences Center in New Orleans, University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis	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