Metronidazole vs Secnidazole for Trichomoniasis

Recruiting at 3 trial locations

Overseen By Christina Muzny, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Tulane University

Must not be taking: Phenytoin, Warfarin, Lithium, Barbiturates

Disqualifiers: Pregnancy, 5-nitroimidazole, Boric acid, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, metronidazole and secnidazole, to determine which is more effective for trichomoniasis, a common sexually transmitted infection. Trichomoniasis can cause itching, burning, and discomfort in the genital area. Individuals who have tested positive for trichomoniasis through specific tests and have not yet started treatment might be suitable candidates. The trial compares a week-long treatment with metronidazole pills to a single-dose treatment with secnidazole. Participants will help researchers determine which treatment is more effective and cost-efficient. As a Phase 4 trial, these treatments are already FDA-approved and proven effective, allowing researchers to understand how they benefit more patients.

Do I need to stop taking my current medications for the trial?

If you are taking phenytoin, warfarin, lithium, or barbiturates, you may need to stop these medications due to interactions with the trial drugs. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What is the safety track record for these treatments?

Research has shown that both metronidazole and secnidazole are generally safe and effective for treating trichomoniasis, a common sexually transmitted infection.

Metronidazole, used for a long time, achieves cure rates between 85-95%. However, resistance may reduce its effectiveness for some individuals. Pregnant women should avoid metronidazole during their first trimester.

Secnidazole is also safe and approved for trichomoniasis treatment. Studies have demonstrated that patients aged 12 and older tolerate it well. Its single-dose regimen makes it convenient and effective in clearing the infection.

Extensive studies support the safety of both treatments for most people. However, side effects may occur, so discussing any concerns with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for trichomoniasis because they offer potentially more convenient options compared to the standard multi-dose metronidazole regimen. Unlike the standard treatment, secnidazole is a single-dose oral medication, which could improve patient compliance and make the treatment process much easier. Additionally, both metronidazole and secnidazole are effective against the T. vaginalis infection, but the option of a single-dose secnidazole may significantly reduce the burden of treatment. These features make the exploration of secnidazole particularly promising for simplifying trichomoniasis management.

What evidence suggests that this trial's treatments could be effective for Trichomoniasis?

This trial will compare the effectiveness of Metronidazole and Secnidazole in treating Trichomonas vaginalis. Research has shown that Metronidazole, which participants may receive, effectively reduces the chance of infection persistence by half when taken over seven days in multiple doses compared to a single dose. Meanwhile, Secnidazole, another treatment option in this trial, has demonstrated high success rates as a single oral dose, curing up to 95.2% of cases in some groups. In certain studies, Secnidazole even achieved a 100% cure rate in specific groups, such as women with other health conditions. Both treatments have proven effective, offering reliable options for eliminating the infection. ^{1 6 7 8 9}

Who Is on the Research Team?

Patricia Kissinger, PhD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

This trial is for men and women with a confirmed Trichomonas vaginalis infection, who haven't been treated yet. They must understand English, agree to follow the study rules, and be okay with being randomly assigned to a treatment group. They need to have contact info like phone or email.

Inclusion Criteria

I tested positive for T. vaginalis, speak English, can be contacted, and agree to follow the study rules.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either multi-dose oral metronidazole (500 mg twice daily for 7 days) or single-dose oral secnidazole (2 g) for the treatment of T. vaginalis infection

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a test of cure (TOC) visit

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Metronidazole
• Secnidazole

Trial Overview The trial compares two drugs: Metronidazole (taken multiple times) versus Secnidazole (a single dose), for treating Trichomonas vaginalis. It's an open-label study, meaning everyone knows which drug they're getting, and it's happening at several centers.

How Is the Trial Designed?

Group I: Single-Dose Secnidazole Experimental Treatment 1 Intervention

Single-dose 2 g oral SEC for the treatment of T. vaginalis infection in women and men

Group II: Oral Multi-Dose Metronidazole Experimental Treatment 1 Intervention

Multi-dose oral MTZ (500 mg twice daily for 7 days) for the treatment of T. vaginalis infection in women and men

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Louisiana State University Health Sciences Center in New Orleans

Collaborator

Trials

123

Recruited

42,400+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Segal Trials Healthcare Clinical Data, Inc

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC523556/

Treatment of Infections Caused by Metronidazole-Resistant ... Metronidazole treatment is generally efficient in eliminating T. vaginalis infection and has a low risk of serious side effects.

2. cdc.gov cdc.gov/std/treatment-guidelines/trichomoniasis.htm

Trichomoniasis - STI Treatment Guidelines Multidose oral metronidazole is more effective than single-dose treatment, particularly for women who are symptomatic or have a history of T. vaginalis (1120).

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309918304237

Single-dose versus 7-day-dose metronidazole for the ... In our 2010 study with HIV-infected women, we found that women receiving the 7-day-dose metronidazole treatment were half as likely to be Trichomonas vaginalis ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9524997/

A pilot study of metronidazole vaginal gel versus oral ... Results: Using culture for test of cure, trichomonal infection was eliminated in all 15 women treated with oral metronidazole and 7 (44%) of 16 women treated ...

5. academic.oup.com academic.oup.com/cid/article/74/Supplement_2/S152/6567967

Diagnosis and Management of Trichomonas vaginalis ... A randomized controlled trial in HIV-uninfected women demonstrated that multidose metronidazole 500 mg twice daily for 7 days reduced the ...

6. canada.ca canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/pathogen-safety-data-sheets-risk-assessment/trichomonas-vaginalis.html

Infectious Substances – Trichomonas vaginalis Metronidazole can be administered orally or intravenously, with cure rates of 85-95%(1); Metronidazole should not be used by pregnant women in their first ...

7. ehs.com ehs.com/resources/sds-resources/free-safety-data-sheet-index/trichomonas-vaginalis/

Trichomonas Vaginalis Free SDS Sheet Metronidazole can be administered orally or intravenously, with cure rates of 85-95%(1); Metronidazole should not be used by pregnant women in their first ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11871923/

Clinical Characteristics of Vaginal Trichomoniasis Infection ... Multiple studies, have shown a gradual increase in metronidazole resistance rates of Trichomonas vaginalis globally, especially among patients ...

9. who.int who.int/news-room/fact-sheets/detail/trichomoniasis

Trichomoniasis More than 50% of women with Trichomonas vaginalis infection have vaginal discharge and about 10% of men have urethritis or urethral discharge.