RECRUITING

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

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.

Conditions

Trichomonas VaginitisBacterial Vaginitis
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Related Conditions:

Trichomonas VaginitisBacterial Vaginitis

Study Overview

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Study Details

Study overview

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.

Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole

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

Condition
Trichomonas Vaginitis
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham [UAB] Gynecology Clinics, Birmingham, Alabama, United States, 25233

Birmingham

UAB Sexual Health Research Clinic [SHRC], Birmingham, Alabama, United States, 35205

North Miami

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

New Orleans

LSU-CrescentCare Sexual Health Center, New Orleans, Louisiana, United States, 70119

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Tulane University,

Patricia Kissinger, PhD, PRINCIPAL_INVESTIGATOR, Tulane University

Study Record Dates

2029-07-31