Refining Treatment Options for Trichomonas Vaginalis Infection in Women and Men: A Comparative Analysis of Oral Multi-Dose Metronidazole and Single-Dose Secnidazole
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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.
Locations
United States
Alabama
UAB Sexual Health Research Clinic [SHRC]
RECRUITING
Birmingham
University of Alabama at Birmingham [UAB] Gynecology Clinics
RECRUITING
Birmingham
Florida
Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161
NOT_YET_RECRUITING
North Miami
Louisiana
LSU-CrescentCare Sexual Health Center
RECRUITING
New Orleans
Contact Information
Primary
Patricia Kissinger, PhD
kissing@tulune.edu
504-988-7320
Backup
Christina Muzny, MD
cmuzny@uabmc.edu
205-975-3298
Time Frame
Start Date:2025-05-06
Estimated Completion Date:2029-07-31
Participants
Target number of participants:1200
Treatments
Experimental: Oral Multi-Dose Metronidazole
Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men
Experimental: Single-Dose Secnidazole
Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men
Collaborators: Segal Trials Healthcare Clinical Data, Inc, Louisiana State University Health Sciences Center in New Orleans, University of Alabama at Birmingham