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

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

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.

Detailed 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. The goal is to refine T. vaginalis treatment for women and men by examining the effectiveness (Aim 1) and cost-effectiveness (Aim 2) of multi-dose oral MTZ versus single-dose oral SEC. The investigators have several secondary analyses for Aim 1 including to examine if bacterial vaginosis (BV) interferes with T. vaginalis treatment, to explore preferences for follow-up visits, and to examine the natural history of T. vaginalis infection in both sexes.

If single-dose oral SEC is found to be superior to multi-dose oral MTZ, this could potentially result in an estimated 280,000 people in the U.S./year receiving better care, having fewer adverse sexual and reproductive health outcomes, and having a reduced risk for HIV acquisition. It will also provide patients with a single-dose oral treatment option that will be particularly attractive for subjects with concomitant T. vaginalis and BV.

Interventions

• Drug Metronidazole 500 mg
  Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men
• Drug Secnidazole 2000 MG
  Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men

Primary outcome measures

• Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure. [Time frame: A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment]

Secondary outcome measures (4)

• To examine if BV co-infection interferes with T. vaginalis treatment [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: at baseline, we document their prior test result (per medical records, survey or onsite testing).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• University of Alabama at Birmingham [UAB] Gynecology Clinics — Birmingham
• UAB Sexual Health Research Clinic [SHRC] — Birmingham
• Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33 — North Miami
• LSU-CrescentCare Sexual Health Center — New Orleans

Publications

• 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

Identifiers

NCT: NCT06261840 · 2024-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗