Single-dose secnidazole versus multi-dose metronidazole for treating Trichomonas vaginalis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center, randomized, open-label, parallel Phase IV trial enrolls adults with laboratory-confirmed Trichomonas vaginalis and randomizes them to either oral multi-dose metronidazole (500 mg) or a single 2,000 mg oral dose of secnidazole. The primary aims are to compare clinical effectiveness and cost-effectiveness between the two regimens. Secondary analyses will examine whether bacterial vaginosis affects treatment response, participant preferences for follow-up visits, and the natural history of infection in both men and women. Study sites include Tulane University, University of Alabama at Birmingham, Louisiana State University collaborators, and participating clinics in Alabama and Florida.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham [UAB] Gynecology Clinics
  Birmingham, Alabama, United States Recruiting
• UAB Sexual Health Research Clinic [SHRC]
  Birmingham, Alabama, United States Recruiting
• LSU-CrescentCare Sexual Health Center
  New Orleans, Louisiana, United States Recruiting
• Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161
  North Miami, Florida, United States Not yet recruiting

Study contacts

• Principal investigator: Patricia Kissinger, PhD — Tulane University
• Study coordinator: Patricia Kissinger, PhD
• Email: kissing@tulune.edu
• Phone: 504-988-7320

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.