Metronidazole vs Secnidazole for Trichomonas Infection
Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
Recruiting
Phase 4Interventional Study
Trichomonas VaginitisBacterial Vaginitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
1,200 (estimated)
Sponsor
Tulane University · Other
Who this trial is looking for
This trial is looking for men and women aged 18 or older who have a confirmed trichomonas vaginalis infection. Participants will compare two different treatments to find out which one is more effective and cost-effective.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have a positive test for trichomonas vaginalis.
I can provide informed consent.
I have a way to be contacted.
I am willing to be randomly assigned to a treatment group.
You may not be able to join if
I am pregnant or breastfeeding.
I have been treated with certain medications in the last 28 days.
I have used any intravaginal treatment in the last 14 days.
I have had a serious allergic reaction to specific medications.
I am taking phenytoin or warfarin.
I am using medications that affect how certain treatments work.
I have been in this study before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 o…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* 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
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