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

Phase 4

Not yet recruiting

• Conditions: Trichomonas Vaginitis
• Interventions: Drug: Secnidazole 2000 MG; Drug: Metronidazole 500 mg

• Registration Number: NCT06261840
• Lead Sponsor: Tulane University

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. 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.

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Study Start: 2024-07-01
• Primary Completion: 2029-05-01
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-Dose Secnidazole	Secnidazole 2000 MG	Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men
Oral Multi-Dose Metronidazole	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

Primary Outcome Measures

Name	Time	Method
Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis	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