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 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.

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