Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metroni⦠(NCT06261840) | Clinical Trial Compass
RecruitingPhase 4
Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
United States1,200 participantsStarted 2025-05-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure.
Timeframe: A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment