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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06261840
Other study ID # 2024-101
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date July 1, 2024
Est. completion date July 31, 2029

Study information

Verified date February 2024
Source Tulane University
Contact Patricia Kissinger, PhD
Phone 504-988-7320
Email kissing@tulune.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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. Our goal is to refine T. vaginalis treatment for women and men by examining the effectiveness (Aim 1) and cost-effectiveness (Aim 2) of multi-dose oral MTZ versus single-dose oral SEC. We have several secondary analyses for Aim 1 including to examine if bacterial vaginosis (BV) interferes with T. vaginalis treatment, to explore preferences for follow-up visits, and to examine the natural history of T. vaginalis infection in both sexes. If single-dose oral SEC is found to be superior to multi-dose oral MTZ, this could potentially result in an estimated 280,000 people in the U.S./year receiving better care, having fewer adverse sexual and reproductive health outcomes, and having a reduced risk for HIV acquisition. It will also provide patients with a single-dose oral treatment option that will be particularly attractive for subjects with concomitant T. vaginalis and BV.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1200
Est. completion date July 31, 2029
Est. primary completion date May 1, 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must have a positive T. vaginalis rapid antigen test, wet mount, or nucleic acid amplification test (NAAT) within two weeks of available results (and have not yet been treated) that is confirmed by repeat T. vaginalis NAAT testing at study enrollment, must speak and understand English and be willing to comply with the study protocol, have a method of contact (either phone, email or social media), and be willing to be randomized. Exclusion Criteria: - Participants will be excluded if they are pregnant/lactating, have been treated for their trichomonas infection with 5-nitroimidazoles (i.e. MTZ, SEC), used intravaginal boric acid or any other intravaginal treatment for T. vaginalis in the last 28 days, or if they have a history of a hypersensitivity reaction to 5-nitroimidazole medications. They also cannot be taking phenytoin (Dilantin) and/or warfarin (Coumadin) due to drug interactions with oral MTZ or have been previously enrolled in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Metronidazole 500 mg
Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men
Secnidazole 2000 MG
Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Tulane University Louisiana State University Health Sciences Center in New Orleans, University of Alabama at Birmingham

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment, as Measured by the Number of Participants that are Cured of Trichomonas Vaginalis A repeat T. vaginalis NAAT test will be completed at the test of cure (TOC) visit A TOC visit will be scheduled 4 weeks (+- 1 week) after post completion of treatment
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