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New single-dose pill may beat week-long treatment for common STI

NCT ID NCT06261840

Cure Sponsor: Tulane University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two oral treatments for trichomonas, a common sexually transmitted infection. About 1,200 women and men with a positive test will receive either a single dose of secnidazole or multiple doses of metronidazole over several days. The goal is to see which approach cures more people at one month and is more cost-effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bacterial vaginosis Trichomonas vaginitis urogenital infection trichomoniasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bacterial vaginitis Trichomonas vaginitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • LSU-CrescentCare Sexual Health Center

    RECRUITING

    New Orleans, Louisiana, 70119, United States

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

    NOT_YET_RECRUITING

    North Miami, Florida, 33161, United States

  • UAB Sexual Health Research Clinic [SHRC]

    RECRUITING

    Birmingham, Alabama, 35205, United States

  • University of Alabama at Birmingham [UAB] Gynecology Clinics

    RECRUITING

    Birmingham, Alabama, 25233, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.