ClinicalTrialsFinder
RecruitingPhase 4NCT06261840

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

Sponsor

Tulane University

Enrollment

1,200 participants

Start Date

May 6, 2025

Study Type

INTERVENTIONAL

Conditions

Trichomonas VaginitisBacterial Vaginitis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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
Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMetronidazole 500 mg

Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men

DRUGSecnidazole 2000 MG

Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men

Locations(4)

University of Alabama at Birmingham [UAB] Gynecology Clinics

Birmingham, Alabama, United States

UAB Sexual Health Research Clinic [SHRC]

Birmingham, Alabama, United States

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

North Miami, Florida, United States

LSU-CrescentCare Sexual Health Center

New Orleans, Louisiana, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06261840