Comparative Performance of a Vaginal Yeast Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-18

Study Completion Date

2026-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Validity of Patient-Collected Wet Mounts

NCT02641717

Vaginal Discharge Trichomonas Candidiasis +2 more

COMPLETED NA

VVC Sampling Study for Analysis Validation

NCT05327192

Vulvovaginal Candidiasis

COMPLETED

Performance Study of the Cobas® BV/CV Test on Samples From Participants With and Without Symptoms of Bacterial Vaginosis and Candida Vaginitis

NCT06975436

Bacterial Vaginosis Candida Vaginitis

COMPLETED

Point-of-care Tests for Bacterial Vaginosis and Candidosis

NCT04287504

Infection, Bacterial Infection, Fungal Preterm Birth

UNKNOWN

Point of Care Diagnosis of Vaginal Infections

NCT06438575

Vaginitis Bacterial Vaginosis Yeast Vaginitis +1 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vulvovaginal Candidiasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Symptomatic for vaginal yeast

Women presenting to the clinic with symptoms of vulvovaginal candidiasis.

SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)

Intervention Type DEVICE

The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), 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 OTC use.

Asymptomatic for vaginal yeast

Women presenting to the clinic with no symptoms of vulvovaginal candidiasis.

SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)

Intervention Type DEVICE

The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), 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 OTC use.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)

The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), 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 OTC use.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes