Clinical trial NCT05033743: Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
Official title: Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Recurrent Bacterial Vaginosis
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Lupin Pharmaceuticals, Inc.
First posted: 2021-09-05
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With at Least One Episode of Bacterial Vaginosis
timeFrame: 30 weeks
measure: Probability of Failure at 210 Days
timeFrame: 210 days (30 weeks)
measure: The Number of Subjects That Failed Treatment in the Supressive Phase
timeFrame: 30 weeks
Secondary outcomes:
measure: Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)
timeFrame: 3-5 days after initial treatment after initial treatment of 2 weeks
measure: Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment
timeFrame: week 6
measure: Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment
timeFrame: week 10
measure: Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment
timeFrame: week 14
measure: Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment
timeFrame: week 18
measure: Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment
timeFrame: week 22
measure: Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment
timeFrame: week 30
Other outcomes:
measure: Number of Participant With Compliance
timeFrame: 18 weeks
measure: Number of Participants With Tolerance
timeFrame: 18 weeks
measure: Number of Adverse Events
timeFrame: 30 weeks
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital - Coleman Center for Women
state: Indiana
Study officials:
affiliation: Assistant Professor
name: Chemen Neal, MD
role: PRINCIPAL_INVESTIGATOR
References: