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

NCT06261840 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2024-101
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Trichomonas Vaginitis; Bacterial Vaginitis

Outcome Measures

Primary Outcomes (1)

• Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure.

  A repeat T. vaginalis NAAT test will be completed at the test of cure (TOC) visit

  A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment

Secondary Outcomes (4)

• To examine if BV co-infection interferes with T. vaginalis treatment

  From enrollment to completion of one-month test of cure for those who test BV positive at baseline.

• To examine if oral single-dose secnidazole is superior to oral multi-dose metronidazole for the treatment of BV.

  From baseline visit to one-month test of cure visit

• A comparison of participant preferences for the test-of-cure (TOC) visit (in clinic versus telemedicine) as captured on baseline survey.

  From baseline visit to one-month test of cure visit

• A comparison of TV NAAT confirmatory test results to determine the percentage who spontaneously clear the infection without medication.

  at baseline, we document their prior test result (per medical records, survey or onsite testing).

Study Arms (2)

Oral Multi-Dose Metronidazole

EXPERIMENTAL

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

Drug: Metronidazole 500 mg

Single-Dose Secnidazole

EXPERIMENTAL

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

Drug: Secnidazole 2000 MG

Interventions

Metronidazole 500 mg DRUG

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

Also known as: FLAGYL

Oral Multi-Dose Metronidazole

Secnidazole 2000 MG DRUG

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

Also known as: SOLOSEC

Single-Dose Secnidazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tulane University: lead
• University of Alabama at Birmingham: collaborator
• Louisiana State University Health Sciences Center in New Orleans: collaborator
• Healthcare Clinical Data: collaborator

Study Sites (4)

University of Alabama at Birmingham [UAB] Gynecology Clinics

Birmingham, Alabama, 25233, United States

RECRUITING

UAB Sexual Health Research Clinic [SHRC]

Birmingham, Alabama, 35205, United States

RECRUITING

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

North Miami, Florida, 33161, United States

NOT YET RECRUITING

LSU-CrescentCare Sexual Health Center

New Orleans, Louisiana, 70119, United States

RECRUITING

Related Publications (1)

• Muzny CA, Lillis RA, Chavoustie SE, Arbuckle JL, Van Gerwen OT, Sagoe M, Kandregula AR, Srivastav S, Kissinger PJ. Refining Trichomonas vaginalis treatment in women and men: protocol for an open-label randomised comparison of multi-dose oral metronidazole versus single-dose oral secnidazole. BMJ Open. 2026 Apr 24;16(4):e116003. doi: 10.1136/bmjopen-2025-116003.

  PMID: 42031495 DERIVED

MeSH Terms

Conditions

Trichomonas Vaginitis; Vaginosis, Bacterial

Interventions

Metronidazole; secnidazole

Condition Hierarchy (Ancestors)

Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Patricia Kissinger, PhD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Kissinger, PhD

CONTACT

504-988-7320; kissing@tulune.edu

Christina Muzny, MD

CONTACT

205-975-3298; cmuzny@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: May 6, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)