Single-dose secnidazole versus multi-dose metronidazole for treating Trichomonas vaginalis
Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole
This compares a single-dose secnidazole pill with multi-dose metronidazole to see if secnidazole works better and costs less for treating Trichomonas in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT06261840 on ClinicalTrials.gov |
What this trial studies
This multi-center, randomized, open-label, parallel Phase IV trial enrolls adults with laboratory-confirmed Trichomonas vaginalis and randomizes them to either oral multi-dose metronidazole (500 mg) or a single 2,000 mg oral dose of secnidazole. The primary aims are to compare clinical effectiveness and cost-effectiveness between the two regimens. Secondary analyses will examine whether bacterial vaginosis affects treatment response, participant preferences for follow-up visits, and the natural history of infection in both men and women. Study sites include Tulane University, University of Alabama at Birmingham, Louisiana State University collaborators, and participating clinics in Alabama and Florida.
Who should consider this trial
Good fit: Adults aged 18 years or older of any sex with recent laboratory-confirmed T. vaginalis who have not yet been treated, can provide informed consent, be contacted, and agree to randomization are eligible candidates.
Not a fit: Those who are pregnant or breastfeeding, seeking pregnancy, recently treated with a 5-nitroimidazole, recently used intravaginal treatments for T. vaginalis, or who are under 18 are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If single-dose secnidazole is superior, patients could receive a convenient, single-dose option that may reduce adverse reproductive outcomes, lower HIV transmission risk, and improve care for an estimated ~280,000 people in the U.S. per year.
How similar studies have performed: Prior clinical studies have indicated that single-dose secnidazole can perform comparably to multi-dose metronidazole, but large head-to-head effectiveness and cost-effectiveness comparisons across varied clinical settings are still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 3 other locations
- University of Alabama at Birmingham [UAB] Gynecology Clinics — Birmingham, Alabama, United States (Recruiting)
- UAB Sexual Health Research Clinic [SHRC] — Birmingham, Alabama, United States (Recruiting)
- Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161 — North Miami, Florida, United States (Not_yet_recruiting)
- LSU-CrescentCare Sexual Health Center — New Orleans, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Patricia Kissinger, PhD — Tulane University
- Study coordinator: Patricia Kissinger, PhD
- Email: kissing@tulune.edu
- Phone: 504-988-7320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.