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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Metronidazole 500 mg
DrugMulti-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men
Secnidazole 2000 MG
DrugSingle-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Oral Multi-Dose MetronidazoleExperimental treatment 1 intervention
Group B: Single-Dose SecnidazoleExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis at one month test of cure.
A repeat T. vaginalis NAAT test will be completed at the test of cure (TOC) visit
Time frame
A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatmentSecondary outcomes
1
To examine if BV co-infection interferes with T. vaginalis treatment
Of those who test positive for BV via BV OSOM at baseline, those who re-test positive via BV OSOM at one-month test-of-cure will be compared by treatment arm.
Time frame
From enrollment to completion of one-month test of cure for those who test BV positive at baseline.2
To examine if oral single-dose secnidazole is superior to oral multi-dose metronidazole for the treatment of BV.
We will conduct a secondary analysis to compare the effectiveness of oral single-dose secnidazole versus oral multi-dose metronidazole among women enrolled in the trial with a diagnosis of BV at baseline. Those who test positive for BV via BV OSOM at baseline will be re-tested and BV positivity at one-month will be compared by treatment arm.
Time frame
From baseline visit to one-month test of cure visit3
A comparison of participant preferences for the test-of-cure (TOC) visit (in clinic versus telemedicine) as captured on baseline survey.
Participants will be asked their preference for an in person one-month test of cure visit that is in person versus telehealth.
Time frame
From baseline visit to one-month test of cure visit4
A comparison of TV NAAT confirmatory test results to determine the percentage who spontaneously clear the infection without medication.
Women and men who previously tested positive for T. vaginalis by nucleic acid amplification test (NAAT) will be retested by NAAT at study entry. The rate of early spontaneous resolution will be calculated.
Time frame
at baseline, we document their prior test result (per medical records, survey or onsite testing).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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