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Completed

NCT Number: NCT05033743

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.

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Key information

Conditions

Recurrent Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Indiana University Hospital - Coleman Center for Women

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secnidazole 2 GM Oral Granules

Drug

Once weekly 2g oral secnidazole for 18 weeks

Primary outcomes

  1. 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.

  2. 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).

  3. 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.

Secondary outcomes

  1. Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)

    Time frame: 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

  2. Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment

    Time frame: 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

  3. Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment

    Time frame: 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

  4. Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment

    Time frame: 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

  5. Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment

    Time frame: 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

  6. Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment

    Time frame: 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

  7. Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment

    Time frame: 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

Other outcomes

  1. Number of Participant With Compliance

    Time frame: 18 weeks

    Subject compliance with the study medication, based on questionnaire that asked if the participant took the medication as scheduled and asked about side effects.

  2. Number of Participants With Tolerance

    Time frame: 18 weeks

    Subject tolerance with the study medication, based on questionnaire that asked if the participant took the medication as scheduled and asked about side effects.

  3. Number of Adverse Events

    Time frame: 30 weeks

    Number of adverse events that participants experienced

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Lupin Pharmaceuticals, Inc.

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Feb 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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