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

May 4, 2026 updated by: Patricia Kissinger, Tulane University

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

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 25233
        • Recruiting
        • University of Alabama at Birmingham [UAB] Gynecology Clinics
        • Contact:
        • Sub-Investigator:
          • Janeen Arbuckle
      • Birmingham, Alabama, United States, 35205
        • Recruiting
        • UAB Sexual Health Research Clinic [SHRC]
        • Contact:
        • Principal Investigator:
          • Christina Muzny
    • Florida
      • North Miami, Florida, United States, 33161
        • Not yet recruiting
        • Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161
        • Contact:
        • Sub-Investigator:
          • Steven Chavoustie
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Recruiting
        • LSU-CrescentCare Sexual Health Center
        • Contact:
        • Sub-Investigator:
          • Rebecca Lillis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 at one month test of cure.
Time Frame: 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
A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To examine if BV co-infection interferes with T. vaginalis treatment
Time Frame: 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.
From enrollment to completion of one-month test of cure for those who test BV positive at baseline.
To examine if oral single-dose secnidazole is superior to oral multi-dose metronidazole for the treatment of BV.
Time Frame: 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.
From baseline visit to one-month test of cure visit
A comparison of participant preferences for the test-of-cure (TOC) visit (in clinic versus telemedicine) as captured on baseline survey.
Time Frame: 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.
From baseline visit to one-month test of cure visit
A comparison of TV NAAT confirmatory test results to determine the percentage who spontaneously clear the infection without medication.
Time Frame: 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.
at baseline, we document their prior test result (per medical records, survey or onsite testing).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tulane University

Collaborators

University of Alabama at Birmingham
Louisiana State University Health Sciences Center in New Orleans
Healthcare Clinical Data

Investigators

  • Principal Investigator: Patricia Kissinger, PhD, Tulane University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2025

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)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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