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New treatment option for Trichomonas Vaginitis
Official title Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole
ClinicalTrials.gov ID: NCT06261840
What this study is testing
What is Metronidazole 500 mg?
Metronidazole 500 mg is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for trichomonas vaginitis.
Also referred to as FLAGYL.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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 assigned by chance.
You likely can't join if
- 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...
See the full eligibility 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...
- 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 assigned by chance.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- North Miami, Florida, United States
- New Orleans, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; North Miami, Florida, United States; New Orleans, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.