Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05079711 |
Other study ID # |
USUHS.2020-058 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 15, 2021 |
Est. completion date |
November 30, 2022 |
Study information
Verified date |
June 2021 |
Source |
Uniformed Services University of the Health Sciences |
Contact |
Elizabeth A Kostas-Polston, PhD |
Phone |
301.295.1531 |
Email |
elizabeth.kostas-polston[@]usuhs.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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 four 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.
Four, large, regional, DoD military treatment facilities (MTFs) representing two branches of
the U.S. military:
1. Womack Army Medical Center (WAMC) at Fort Bragg; Fayetteville, NC
2. Naval Medical Center San Diego (NMCSD); San Diego, CA
3. Naval Medical Center Portsmouth (NMCP); Portsmouth, VA
4. Landstuhl Regional Medical Center (LRMC); Landstuhl, Germany
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.