Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to test the effectiveness Secnidazole to treat recurrent BV. Secnidazole is approved for one-time use in acute BV. In this study, the drug will be used for recurrent BV, and given weekly for 18 weeks.

Detailed Description
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A single-center prospective pilot study with once-weekly oral secnidazole granule treatment of acute condition for two-weeks followed by prophylactic treatment of asymptomatic responders with once-weekly secnidazole for 16 weeks, followed by no therapy for 12 weeks. The final follow-up evaluation is at week 28. Eligible women with a current symptomatic bacterial vaginosis infection (> or = 3 Amsel criteria) and a history of at least 2 previous episodes of bacterial vaginosis in the past year will be enrolled in the open-label treatment study. All women will be treated with 2g of secnidazole granules orally once-weekly for 2 weeks. At the second visit, 3-5 days after completion of treatment, women who have a resolution of bacterial vaginosis (asymptomatic and < or = 2 Amsel criteria) will continue on once-weekly secnidazole for 16 weeks. Patients will be evaluated every 4 weeks for recurrence of bacterial vaginosis. This will include questions about symptoms as well as a pelvic examination for assessment of vaginal discharge (> or = 3 Amsel criteria). We will also collect any information on other clinical evaluations for recurrence and the dates of diagnoses and types of treatments they may have received. Those who remain without recurrence during the 16-week suppressive phase will be followed for an additional 12 weeks off therapy, with assessment for recurrence at weeks 22 and 30. Throughout the study, data will be collected on participants' compliance and on the occurrence of adverse events.

Official Title
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Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study

Conditions
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Recurrent Bacterial Vaginosis

Intervention / Treatment
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* Drug: Secnidazole 2 GM Oral Granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to consent in English Current symptomatic bacterial vaginosis infection History of at least 2 previous episodes of bacterial vaginosis in the past year Exclusion Criteria: Current gynecologic infection or condition, including candida vaginitis, gonorrhea, chlamydia, trichomonas, desquamative inflammatory vaginitis, atrophic vaginitis. Pre-existing heart conditions Pre-existing neurological conditions Currently Pregnant or breastfeeding Women taking anticoagulants, lithium, metoclopramide, or disulfiram therapy Hypersensitivity to secnidazole or other drugs in the same class.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Secnidazole treatment | Drug: Secnidazole 2 GM Oral Granules<br>* Once weekly 2g oral secnidazole for 18 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoint - Failed Treatment | Number of subjects with at least one episode of bacterial vaginosis in the 30 week follow-up period | 30 weeks | 
| Efficacy Endpoint | Time to failure | Days up to 210 days (30 weeks) | 
| Efficacy Endpoint | Number of failures | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence | Amsel criteria or Nugent criteria | 3-5 days after initial treatment | 
| Time to recurrence | Amsel criteria or Nugent criteria | week 6 | 
| Time to recurrence | Amsel criteria or Nugent criteria | week 10 | 
| Time to recurrence | Amsel criteria or Nugent criteria | week 14 | 
| Time to recurrence | Amsel criteria or Nugent criteria | week 18 | 
| Time to recurrence | Amsel criteria or Nugent criteria | week 22 | 
| Time to recurrence | Amsel criteria or Nugent criteria | week 30 |