Trial Outcomes & Findings for Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study (NCT NCT05033743)

NCT ID: NCT05033743

Last Updated: 2024-02-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 24 participants
• Primary outcome timeframe: 30 weeks
• Results posted on: 2024-02-05

Participant Flow

Participant milestones

Measure	Treatment Group Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Treatment Group Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Overall Study Lost to Follow-up	1
Overall Study Protocol Violation	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

4 participants were withdrawn or lost to followup before this baseline measure was collected. These participants were excluded from analysis.

Baseline characteristics by cohort

Measure	Secnidazole n=24 Participants prescribed once-weekly secnidazole for 16 weeks as prophylactic treatment
Age, Categorical <=18 years	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=24 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants
Age, Continuous	35.3 years STANDARD_DEVIATION 9.8 • n=24 Participants
Sex: Female, Male Female	24 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=24 Participants
Race/Ethnicity, Customized Black	16 Participants n=24 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=24 Participants
Race/Ethnicity, Customized White	7 Participants n=24 Participants
Region of Enrollment United States	24 participants n=24 Participants
Bacterial Vaginosis (BV) episodes in prior 12 months	8.1 episodes STANDARD_DEVIATION 6.4 • n=20 Participants • 4 participants were withdrawn or lost to followup before this baseline measure was collected. These participants were excluded from analysis.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment Group n=20 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Subjects With at Least One Episode of Bacterial Vaginosis	8 Participants

PRIMARY outcome

Timeframe: 210 days (30 weeks)

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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).

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Probability of Failure at 210 Days	0.7051 Probability

PRIMARY outcome

Timeframe: 30 weeks

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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.

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
The Number of Subjects That Failed Treatment in the Supressive Phase	3 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Treatment Group n=20 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Subjects Who Experienced Recurrence 3-5 Days After Initial Treatment (Initial Treatment Was 2 Weeks Long)	5 Participants

SECONDARY outcome

Timeframe: week 6

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Subjects Who Experienced Recurrence 6 Weeks After Start of Initial Treatment	0 Participants

SECONDARY outcome

Timeframe: week 10

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Subjects Who Experienced Recurrence 10 Weeks After Start of Initial Treatment	0 Participants

SECONDARY outcome

Timeframe: week 14

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Subjects Who Experienced Recurrence 14 Weeks After Start of Initial Treatment	1 Participants

SECONDARY outcome

Timeframe: week 18

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Subjects Who Experienced Recurrence 18 Weeks After Start of Initial Treatment	1 Participants

SECONDARY outcome

Timeframe: week 22

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Subjects Who Experienced Recurrence 22 Weeks After Start of Initial Treatment	2 Participants

SECONDARY outcome

Timeframe: week 30

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Subjects Who Experienced Recurrence 30 Weeks After Start of Initial Treatment	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 weeks

Population: The calculation only includes participants who began the suppression portion of the study and participants who were not withdrawn or lost to follow-up.

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

Outcome measures

Measure	Treatment Group n=15 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Participant With Compliance	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 weeks

Population: This number of participants includes all subjects, including lost to follow up and withdraws. Only one subject reported intolerance of the medication.

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

Outcome measures

Measure	Treatment Group n=25 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Participants With Tolerance	24 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 weeks

Population: Analysis only includes participants who experienced an AE.

Number of adverse events that participants experienced

Outcome measures

Measure	Treatment Group n=10 Participants Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Number of Adverse Events	41 adverse events

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment Group n=24 participants at risk Secnidazole treatment Secnidazole 2 GM Oral Granules: Once weekly 2g oral secnidazole for 18 weeks
Skin and subcutaneous tissue disorders Yeast Infection	29.2% 7/24 • Number of events 12 • 1 year
Nervous system disorders Headache	8.3% 2/24 • Number of events 4 • 1 year
Gastrointestinal disorders Loose Stool	8.3% 2/24 • Number of events 2 • 1 year
Gastrointestinal disorders Nausea	4.2% 1/24 • Number of events 2 • 1 year
Renal and urinary disorders UTI	8.3% 2/24 • Number of events 2 • 1 year
Gastrointestinal disorders left lower quadrent pain	4.2% 1/24 • Number of events 1 • 1 year
Reproductive system and breast disorders spotting	4.2% 1/24 • Number of events 1 • 1 year
Renal and urinary disorders urinary odor	4.2% 1/24 • Number of events 1 • 1 year
Reproductive system and breast disorders change in discharge	4.2% 1/24 • Number of events 1 • 1 year
Infections and infestations COVID-19 infection	4.2% 1/24 • Number of events 1 • 1 year
Vascular disorders Post Operative Pulmonary Embolism	4.2% 1/24 • Number of events 1 • 1 year

Additional Information

Chemen M. Neal, Associate Professor

Indiana University School of Medicine

Phone: 3172789639

Email: chmtate@iupui.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place