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

Launched by TULANE UNIVERSITY · Feb 7, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Refining Treatment Options for Trichomonas Vaginalis Infection," is studying two different medications to treat a common infection called Trichomonas vaginalis, which affects both women and men. The trial aims to compare the effectiveness and cost-effectiveness of two treatments: metronidazole, which requires multiple doses, and secnidazole, which is taken as a single dose. The goal is to see which treatment works better for patients.

To participate in this study, you need to have a positive test for Trichomonas vaginalis within the last two weeks and not have received treatment yet. You also need to speak and understand English, be willing to follow the study rules, and have a way to be contacted, like a phone or email. However, if you are pregnant, have been treated for this infection recently, or have certain health conditions, you may not be eligible. If you join the study, you will be randomly assigned to receive either metronidazole or secnidazole, and researchers will monitor your progress to gather important information about these treatments. This study is not yet recruiting participants, but it will help improve future treatment options for this infection.

Gender

ALL

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