Diagnostic Accuracy By Providers Study

Vaginitis Clinical Trial

— DAP  

Official title:

Diagnostic Accuracy By Providers Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03151928
• Other study ID #: PRO17030332
• Status: Completed
• Start date: July 6, 2017
• Est. completion date: August 15, 2018

Study information

• Verified date: October 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaginitis

Intervention

Diagnostic Test:
• BDMax Vaginal Panel
The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC/associated community clinics	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Becton Dickinson Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BV Result Agreement	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	enrollment
Primary	Trichomonas (TV) Result Agreement	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	enrollment
Primary	Yeast Result Agreement	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	enrollment
Secondary	Patterns of clinician testing	Description of the patterns of testing among clinicians in the community practice providing care for women presenting with symptoms of vaginitis	enrollment
Secondary	Prescribed Treatments	Description of the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory confirmed diagnoses.	enrollment