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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Bacterial Vaginosis
• Intervention / Treatment: Drug: Secnidazole 2 GM Oral Granules

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Graham A Hogg; Phone Number: 3179620415; Email: gahogg@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Hospital - Coleman Center for Women

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Secnidazole treatment	Drug: Secnidazole 2 GM Oral Granules; Once weekly 2g oral secnidazole for 18 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With at Least One Episode of Bacterial Vaginosis	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.	30 weeks
Probability of Failure at 210 Days	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).	210 days (30 weeks)
The Number of Subjects That Failed Treatment in the Supressive Phase	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.	30 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)	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	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	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	week 6
Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment	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	week 10
Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment	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	week 14
Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment	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	week 18
Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment	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	week 22
Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment	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	week 30

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participant With Compliance	Subject compliance with the study medication, based on questionnaire that asked if the participant took the medication as scheduled and asked about side effects.	18 weeks
Number of Participants With Tolerance	Subject tolerance with the study medication, based on questionnaire that asked if the participant took the medication as scheduled and asked about side effects.	18 weeks
Number of Adverse Events	Number of adverse events that participants experienced	30 weeks

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Lupin Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Chemen Neal, MD, Assistant professor

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Actual): October 7, 2022
• Study Completion (Actual): October 7, 2022

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Recurrence; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Secnidazole
• Other Study ID Numbers: 10283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No