Diagnostic Accuracy By Providers Study

Completed

• Conditions: Vaginitis
• Interventions: Diagnostic Test: BDMax Vaginal Panel

• Registration Number: NCT03151928
• Lead Sponsor: University of Pittsburgh

Brief Summary

The validation study is intended to provide comparative data on the diagnosis of vaginal infections as performed in primary care settings versus the diagnosis provided through standard diagnostic testing performed in a reference laboratory. The clinician and lab diagnoses will be compared to those obtained using the BD MAX Vaginal Panel on the BD MAX System.

Detailed Description

The primary goals of this study are to:

1. Compare the level of agreement of clinician diagnosed bacterial vaginosis (BV) to vaginal swab samples evaluated for BV using Nugent's criteria and the BD MAX Vaginal Panel

2. Compare the level of agreement of clinician diagnosed trichomonas vaginalis (TV) to the laboratory diagnosis of TV identified by quantitative PCR using the GeneXpert system by Cepheid and the BD MAX Vaginal Panel.

3. Compare the level of agreement of clinician diagnosed yeast vaginitis to laboratory diagnosis of yeast identified with culture and the BD MAX Vaginal Panel.

The secondary goals of this study include:

1. Being able to describe the patterns of testing among clinicians in community practices providing routine care for women presenting with symptoms of vaginitis.

2. Describe the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory-confirmed diagnoses.

Study Timeline

• Study First Submitted: 2017-05-10
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Study Start: 2017-07-06
• Primary Completion: 2018-08-15
• Study Completion: 2018-08-15
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 299

Inclusion Criteria

1. Female, Age 18-40
2. Presenting with symptoms of vaginitis; vaginal discharge, vaginal odor, vulvar or vaginal itch, vulvar or vaginal discomfort (i.e. irritation, burning pain or vulvar edema).
3. Able and willing to provide verbal consent.
4. Willingness to undergo all study-related assessments and procedures, including the collection of multiple vaginal swabs, answer questions related to demographic and health information and follow all other study-related procedures.

Exclusion:

Women who meet any of the following criteria by participant report will be excluded from the study:

1.) Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women presenting with vaginitis symptoms	BDMax Vaginal Panel	Women with vaginitis seeking routine care will be approached to have five additional swabs collected during their pelvic exam * vaginal swab for qualitative PCR using the BD Max Vaginal Panel on the automated BDMAX System * Vaginal smear for evaluation with Gram's stain and Nuget's criteria * Vaginal swab for yeast culture * Vaginal swab for Trichomonas vaginalis NAAT * Vaginal swab for discrepant analysis testing

Primary Outcome Measures

Name	Time	Method
BV Result Agreement	enrollment	Comparison of the level of agreement of clinician diagnosed BV to vaginal swab samples evaluated for BV using Nugent's criteria and the BD MAX Vaginal Panel
Trichomonas (TV) Result Agreement	enrollment	Comparison of the level of agreement of clinician diagnosed TV to the laboratory diagnosis of TV identified by quantitative PCR using the GeneXpert system by Cepheid and the BD MAX Vaginal Panel
Yeast Result Agreement	enrollment	Comparison of the level of agreement of clinician diagnosed yeast vaginitis to laboratory diagnosis of yeast identified with culture and the BD MAX Vaginal Panel

Secondary Outcome Measures

Name	Time	Method
Prescribed Treatments	enrollment	Description of the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory confirmed diagnoses.
Patterns of clinician testing	enrollment	Description of the patterns of testing among clinicians in the community practice providing care for women presenting with symptoms of vaginitis

Trial Locations

Locations (1)

Magee-Womens Hospital of UPMC/associated community clinics; 🇺🇸 Pittsburgh, Pennsylvania, United States