NCT06261840 Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
| NCT ID | NCT06261840 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Tulane University |
| Condition | Trichomonas Vaginitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2025-05-06 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,200 participants in total. It began in 2025-05-06 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Patricia Kissinger, PhD
PRINCIPAL INVESTIGATOR
Tulane University
Frequently Asked Questions
Who can join the NCT06261840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Trichomonas Vaginitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06261840 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06261840 currently recruiting?
Yes, NCT06261840 is actively recruiting participants. Contact the research team at kissing@tulune.edu for enrollment information.
Where is the NCT06261840 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, North Miami, United States, New Orleans, United States.
Who is sponsoring the NCT06261840 clinical trial?
NCT06261840 is sponsored by Tulane University. The principal investigator is Patricia Kissinger, PhD at Tulane University. The trial plans to enroll 1,200 participants.