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

RecruitingPhase 4Ages 18 Years - anyAllTulane University
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Metronidazole 500 mg
  • Secnidazole 2000 MG
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Where

4 sites
University of Alabama at Birmingham [UAB] Gynecology Clinics
Birmingham, United States
UAB Sexual Health Research Clinic [SHRC]
Birmingham, United States
Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161
North Miami, United States
LSU-CrescentCare Sexual Health Center
New Orleans, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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