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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trichomonas Vaginitis
• Intervention / Treatment: Drug: Metronidazole 500 mg; Drug: Secnidazole 2000 MG

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 Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Patricia Kissinger, PhD; Phone Number: 504-988-7320; Email: kissing@tulune.edu
• Study Contact Backup: Name: Christina Muzny, MD; Phone Number: 205-975-3298; Email: cmuzny@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Multi-Dose Metronidazole; Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men	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; Other Names: FLAGYL
Experimental: Single-Dose Secnidazole; Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men	Drug: Secnidazole 2000 MG; Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men; Other Names: SOLOSEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: University of Alabama at Birmingham; Louisiana State University Health Sciences Center in New Orleans
• Investigators: Principal Investigator: Patricia Kissinger, PhD, Tulane University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Protozoan Infections; Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginitis; Trichomonas Vaginitis; Trichomonas Infections; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Secnidazole
• Other Study ID Numbers: 2024-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes