Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
NCT ID: NCT06261840
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1200 participants
INTERVENTIONAL
2025-05-06
2029-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Single-Dose Secnidazole
Single-dose 2 g oral SEC 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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Alabama at Birmingham
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
Segal Trials Healthcare Clinical Data, Inc
UNKNOWN
Tulane University
OTHER
Responsible Party
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Patricia Kissinger
Principal Investigator
Principal Investigators
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Patricia Kissinger, PhD
Role: PRINCIPAL_INVESTIGATOR
Tulane University
Locations
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University of Alabama at Birmingham [UAB] Gynecology Clinics
Birmingham, Alabama, United States
UAB Sexual Health Research Clinic [SHRC]
Birmingham, Alabama, United States
Segal Trials Healthcare Clinical Data, Inc. 1065 NE 125th St. Suite 417 North Miami, FL 33161
North Miami, Florida, United States
LSU-CrescentCare Sexual Health Center
New Orleans, Louisiana, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-101
Identifier Type: -
Identifier Source: org_study_id
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