Large Algorithm Setting and Validation Study

ConditionsBacterial Infections Bacterial Infections and Mycoses Infections Vaginitis Vaginal Diseases Genital Diseases, Female Female Urogenital Diseases Urogenital Disease Candidiasis Mycoses Vulvovaginitis Vulvar Diseases Vaginosis, Bacterial

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorNanopath, Inc

About this trial

In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay.

The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Abnormal vaginal discharge

Vaginal or vulvar itching, burning, or irritation

Painful or uncomfortable intercourse

Vaginal odor

Disqualifiers

Participants who do not meet the above-described inclusion criteria will be excluded from the study.

Previously enrolled in this study

Contraindication to vaginal swab sampling

Trial population

The intended use population will be up to 1000 symptomatic participants with a clinical presentation consistent with vaginitis.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Nanopath Vaginitis Assay
Diagnostic test
Investigational Device
BD Max™ Vaginal Panel
Diagnostic test
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Cepheid Xpert® Xpress MVP
Diagnostic test
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Hologic Aptima® BV Assay
Diagnostic test
This is an FDA-cleared diagnostic test that will be used as labelled. It will serve as one of three NAAT comparators in this study.
Yeast Culture
Diagnostic test
Culture plus use of MALDI-TOF (Matrix-Assisted Laser Desorption/Ionization Time-of-Flight mass spectrometry) for required speciation.

Treatment groups

1,000 Participants

are divided into 1 treatment group

Group A: Vaginal Infections (BV, CV, TV)5 interventions

Trial outcomes

Primary outcomes

Accuracy of Nanopath Assay for Diagnosis of Vaginal Infections

Compare the sensitivity and specificity of the Nanopath assay to NAAT and yeast culture for diagnosing vaginitis

Time frame

1 day

Secondary outcomes

Equivalency of Percent Agreement Between Self-Collected and Clinician-Collected Samples Using the Nanopath Assay

Compare the performance between clinician-collected samples and self-collected samples using the Nanopath assay for diagnosing vaginitis.

Time frame

1 day

Sponsors and contacts

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

Nanopath, Inc

Lead sponsor

Source ClinicalTrials.gov

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