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Comparing Metronidazole and Secnidazole for Trichomonas Vaginalis Infection

This study is comparing two common treatments for Trichomonas vaginalis (a common sexually transmitted infection) in both women and men: Metronidazole (given as multiple doses over 7 days) and Secnidazole (given as a single dose). The goal is to see which treatment is more effective and cost-effective. You might be able to join if you are 18 or older and have a confirmed Trichomonas vaginalis infection that hasn't been treated yet. The study will measure success by seeing how many participants are cured of the infection one month after treatment. The current recruitment status is unclear.

Study design
This is a multi-center, randomized, open-label study comparing two treatments. It plans to include 1200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a follow-up visit about 4 weeks after finishing treatment to check if the infection is cured.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06261840

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Tulane University
~1,200 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Metronidazole 500 mgSecnidazole 2000 MG

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure.
Measured over A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment

Conditions

Trichomonas Vaginitis
Bacterial Vaginitis

Explore related trials

Bacterial VaginosisTrichomonas Vaginitis

NCT06261840

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • LSU-CrescentCare Sexual Health Center

    New Orleans, Louisianastudy coordinator listed

    Recruiting

  • Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161

    North Miami, Floridastudy coordinator listed

    Not yet recruiting

  • UAB Sexual Health Research Clinic [SHRC]

    Birmingham, Alabamastudy coordinator listed

    Recruiting

  • University of Alabama at Birmingham [UAB] Gynecology Clinics

    Birmingham, Alabamastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Patricia Kissinger, PhD · PRINCIPAL_INVESTIGATOR · Tulane University

Who to contact

Patricia Kissinger, PhD
[email protected]
504-988-7320
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure.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