Clinical trial NCT05079711: Comparative Performance of a Vaginal Yeast Test
Official title: Comparative Performance of the SavvyCheck Vaginal Yeast Test Versus Culture
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vulvovaginal Candidiasis
Keywords: Vaginal candidiasis, Vaginal yeast culture
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
Collaborators: name: Savvyon Diagnostics Ltd.
First posted: 2021-10-15
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women, aged 18 years and older, symptomatic and asymptomatic for vaginitis will be enrolled in the study. We estimate that it will require a total enrollment of up to 600 symptomatic women at all clinical sites combined, to achieve the target of at least n=216 Reference Method (vaginal Candida yeast culture) positives. In addition, a combined total of 320 asymptomatic women will be enrolled in the study from the four clinical sites combined, to achieve the target of at least n=170 Reference Method (vaginal Candida yeast culture) negatives.

Brief summary: The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.

Detailed description: The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-performed SavvyCheck Vaginal Yeast Test and standard vaginal yeast culture and identification method for Candida.

Primary Objective:

The primary objective is to establish lay user performance criteria (sensitivity and specificity) of the SavvyCheck Vaginal Yeast Test in comparison to the Reference Method (vaginal Candida yeast culture)

Secondary Objectives:

1. To determine the positive predictive value and negative predictive value of the lay user-performed SavvyCheck Vaginal Yeast Test in comparison to the Reference Method (vaginal Candida yeast culture)
2. To determine the concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. trained user-performed SavvyCheck Vaginal Yeast Test

Exploratory Objectives:

1. To determine the concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy results
2. To determine the concordance between results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing
3. To determine the concordance between results determined by the Reference Method (vaginal Candida yeast culture) -vs. PCR and sequencing

Primary Endpoints:

Calculation of sensitivity and specificity of the lay user-performed SavvyCheck Vaginal Yeast Test as compared to the Reference Method (vaginal Candida yeast culture)

Secondary Endpoints:

1. Calculation of positive and negative predictive value of lay user-performed SavvyCheck Vaginal Yeast Test results as compared to the Reference Method (vaginal Candida yeast culture)
2. Calculation of concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test results -vs. trained user-performed SavvyCheck Vaginal Yeast Test results

Exploratory Endpoints:

1. Calculation of concordance between the results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy
2. Calculation of concordance between results determined by lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing
3. Calculation of concordance between results determined by the Reference Method (vaginal Candida yeast culture) -vs. PCR and sequencing

Women, aged 18 years and older, symptomatic and asymptomatic for vaginitis will be enrolled in the study. We estimate that it will require a total enrollment of up to 600 symptomatic women at all clinical sites combined, to achieve the target of at least n=216 Reference Method (vaginal Candida yeast culture) positives. In addition, a combined total of 320 asymptomatic women will be enrolled in the study from the four clinical sites combined, to achieve the target of at least n=170 Reference Method (vaginal Candida yeast culture) negatives.

Three, large, regional, DoD military treatment facilities (MTFs)

1. Womack Army Medical Center (WAMC) at Fort Liberty; Fayetteville, NC
2. Landstuhl Regional Medical Center (LRMC); Landstuhl, Germany
3. Brooke Army Medical Center (BAMC); Fort Sam Houston, TX

The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for the detection of Candida antigen in vaginal secretions sampled by a swab, as an aid for identification of vulvovaginal candidiasis as a primary cause of vaginal yeast infections. The SavvyCheck Vaginal Yeast Test is designed for use by women experiencing vaginal symptoms, including: increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination. The SavvyCheck Vaginal Yeast Test is indicated for over-the-counter use.

Eligibility criteria: Inclusion Criteria:

Symptomatic Women Symptomatic women include those women who present with a complaint consistent with symptoms of vaginitis (e.g., increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination). Enrollment will continue at each clinical site until our target number of 216 Reference Method (vaginal Candida yeast culture) positives have been collected. We estimate up to 600 symptomatic women will be enrolled to meet our target.

Inclusion Criteria for Symptomatic Women

1. DoD Military Health System beneficiary
2. Have a healthcare appointment at a recruitment clinic
3. 18 years of age or older
4. Must speak and understand English
5. Able to provide informed consent
6. Women experiencing vaginal symptoms, including: increased discharge, itching, soreness and irritation, rash on the labia, and genital burning that may worsen during urination
7. Must determine the test is applicable to her based on her symptoms after she has read the outside device labeling (box label)

Asymptomatic Women Asymptomatic women include those women who do not present with a complaint consistent with vaginitis. Enrollment will continue at each clinical site until our target number of 170 Reference Method (vaginal Candida yeast culture) negatives have been collected. We estimate up to 320 asymptomatic women will be enrolled to meet our target.

Inclusion Criteria for Asymptomatic Women:

1. DoD Military Health System beneficiary
2. Have a healthcare appointment at a recruitment clinic
3. 18 years of age or older
4. Must speak and understand English
5. Able to provide informed consent
6. Healthy women appearing for routine care without symptoms of vaginal yeast infection

Exclusion Criteria:

If any of the following criteria are met, a potential subject will be excluded from the study:

1. Currently menstruating
2. History of any clinical therapies and/or interventions related to gender confirmation (transgender person)
3. Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days
4. Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions

NOTE: Women who currently have an intrauterine device (IUD) placed are eligible to participate

Primary outcomes:
measure: Assess sensitivity and specificity between lay user-performed SavvyCheck Vaginal Yeast Test result compared to the Reference Method (vaginal Candida yeast culture)
timeFrame: 12 months
Secondary outcomes:
measure: Assess positive and negative predictive values of the lay-user SavvyCheck Vaginal Yeast Test result as compared to the Reference Method (vaginal Candida yeast culture)
timeFrame: 12 months
measure: Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result and the trained user-performed result.
timeFrame: 12 months
Other outcomes:
measure: Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result -vs vaginal wet mount microscopy
timeFrame: 12 months
measure: Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result -vs. PCR and sequencing
timeFrame: 12 months
measure: Assess concordance between the Reference Method results (vaginal yeast culture) -vs PCR and sequencing
timeFrame: 12 months
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Elizabeth A Kostas-Polston, PhD
role: PRINCIPAL_INVESTIGATOR
References: