Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of Subjects With at Least One Episode of Bacterial Vaginosis
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment Group
Secnidazole treatment
Intervention: Secnidazole 2 GM Oral Granules (Drug)
Outcomes
Primary Outcomes
Number of Subjects With at Least One Episode of Bacterial Vaginosis
Time Frame: 30 weeks
Overall failure rate as measured by the number of subjects with at least one episode of bacterial vaginosis in the 30 week follow-up period.
The Number of Subjects That Failed Treatment in the Supressive Phase
Time Frame: 30 weeks
The probability of recurrence or treatment failure was calculated as time from the second visit in days. This timeframe is the suppressive therapy phase and was 30 weeks long.
Probability of Failure at 210 Days
Time Frame: 210 days (30 weeks)
To assess the efficacy of secnidazole, we estimated failure rates and 95% exact confidence intervals for initial treatment, suppression therapy following initial resolution of BV symptoms, and overall. For the time-to-failure analysis, time was defined as the number of days since the second visit where clinical resolution of initial BV was confirmed. The non-parametric maximum likelihood estimate (NPMLE) of the survival curve was estimated using the interval package in R to account for the interval censored data. Results are presented using an Amsel criteria score of as well as for BV diagnosis. All analyses were conducted using R 4.2.2 (R Core Team, 2020) in RStudio (RStudio Team 2021).
Secondary Outcomes
- Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment(week 18)
- Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment(week 22)
- Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)(3-5 days after initial treatment after initial treatment of 2 weeks)
- Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment(week 6)
- Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment(week 14)
- Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment(week 30)
- Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment(week 10)
Investigators
Chemen M. Neal
Assistant Clinical Professor
Indiana University