Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTulane University
About this trial
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
Qualifiers
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),
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metronidazole 500 mg
- Secnidazole 2000 MG
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tulane University
Lead sponsor
University of Alabama at Birmingham
Collaborator
Louisiana State University Health Sciences Center in New Orleans
Collaborator
Healthcare Clinical Data
Collaborator
Source ClinicalTrials.gov