Health TrialsbyHealthPanel

Comparative Performance of a Vaginal Yeast Test

ConditionVulvovaginal Candidiasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniformed Services University of the Health Sciences

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

DoD Military Health System beneficiary

Have a healthcare appointment at a recruitment clinic

18 years of age or older

Must speak and understand English

Disqualifiers

Currently menstruating

History of any clinical therapies and/or interventions related to gender confirmation (transgender person)

Use of any vaginal medication, taken by mouth or vaginally, within the last 7 days

Use of any vaginal product within 24 hours, including contraception (cream, gel, or foam), or douching solutions

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    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.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Symptomatic for vaginal yeast1 intervention
Group B: Asymptomatic for vaginal yeast1 intervention

Trial outcomes

Primary outcomes

1

Assess sensitivity and specificity between lay user-performed SavvyCheck Vaginal Yeast Test result compared to the Reference Method (vaginal Candida yeast culture)

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

Time frame
12 months

Secondary outcomes

1

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)

Calculation of the positive and negative predictive values of lay user-performed SavvyCheck Vaginal Yeast Test results as compared to the Reference Method (vaginal Candida yeast culture).

Time frame
12 months
2

Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result and the trained user-performed result.

Calculation of concordance between the lay use-performed and the trained user-performed SavvyCheck Vaginal Yeast test results.

Time frame
12 months

Other outcomes

1

Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result -vs vaginal wet mount microscopy

Calculation of concordance between the results between the lay user-performed SavvyCheck Vaginal Yeast Test -vs. vaginal wet mount microscopy

Time frame
12 months
2

Assess concordance between the lay user-performed SavvyCheck Vaginal Yeast test result -vs. PCR and sequencing

Calculation of concordance between the results between the lay user-performed SavvyCheck Vaginal Yeast Test -vs. PCR and sequencing

Time frame
12 months
3

Assess concordance between the Reference Method results (vaginal yeast culture) -vs PCR and sequencing

Calculation of concordance between the Reference Method (vaginal yeast culture) results -vs PCR and sequencing

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uniformed Services University of the Health Sciences

Lead sponsor

Savvyon Diagnostics Ltd.

Collaborator

Source ClinicalTrials.gov
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