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

Phase 2

Completed

Conditions: Recurrent Bacterial Vaginosis

Interventions: Drug: Secnidazole 2 GM Oral Granules

Registration Number: NCT05033743

Lead Sponsor: Indiana University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 24

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Secnidazole 2 GM Oral Granules	Secnidazole treatment

Primary Outcome Measures

Name	Time	Method
Number of Subjects With at Least One Episode of Bacterial Vaginosis	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	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	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 Outcome Measures

Name	Time	Method
Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment	week 18	Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH \> 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment	week 22	Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH \> 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
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	Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH \> 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment	week 6	Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH \> 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment	week 14	Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH \> 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment	week 30	Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH \> 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy
Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment	week 10	Recurrence was measured using the Amsel criteria. The Amsel criteria are: 1) Homogenous white discharge, 2) pH \> 4.5, 3) amine odor (whiff) test, 4) clue cells on microscopy