RECRUITING

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

Conditions

Trichomonas Vaginitis Bacterial Vaginitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-06

Study Completion:2029-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06261840

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Patricia Kissinger, PhD

CONTACT

504-988-7320

kissing@tulune.edu

Christina Muzny, MD

CONTACT

205-975-3298

cmuzny@uabmc.edu

Principal Investigator

Patricia Kissinger, PhD

PRINCIPAL_INVESTIGATOR

Tulane University

Study Locations (Sites)

University of Alabama at Birmingham [UAB] Gynecology Clinics

Birmingham, Alabama, 25233

United States

UAB Sexual Health Research Clinic [SHRC]

Birmingham, Alabama, 35205

United States

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

North Miami, Florida, 33161

United States

LSU-CrescentCare Sexual Health Center

New Orleans, Louisiana, 70119

United States

Collaborators and Investigators

Sponsor: Tulane University

Patricia Kissinger, PhD, PRINCIPAL_INVESTIGATOR, Tulane University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-06

Study Completion Date2029-07-31

Study Record Updates

Study Start Date2025-05-06

Study Completion Date2029-07-31

Terms related to this study

Additional Relevant MeSH Terms

Trichomonas Vaginitis
Bacterial Vaginitis