Diagnostic Accuracy By Providers Study

NCT03151928 | Completed

• 1 other identifier: PRO17030332
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginitis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Patterns of clinician testing

  enrollment

• Prescribed Treatments

  enrollment

Study Arms (1)

women presenting with vaginitis symptoms

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

Diagnostic Test: BDMax Vaginal Panel

Interventions

BDMax Vaginal Panel DIAGNOSTIC_TEST

The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions

Also known as: Gram Stain/Nuget Criteria, yeast culture, Trichomonas vaginalis NAAT

women presenting with vaginitis symptoms

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women presenting to primary care offices with symptoms of vaginitis

You may qualify if:

• Female, Age 18-40
• 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).
• Able and willing to provide verbal consent.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Becton Dickinson Life Sciences: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC/associated community clinics

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Hillier SL, Austin M, Macio I, Meyn LA, Badway D, Beigi R. Diagnosis and Treatment of Vaginal Discharge Syndromes in Community Practice Settings. Clin Infect Dis. 2021 May 4;72(9):1538-1543. doi: 10.1093/cid/ciaa260.

  PMID: 32350529 DERIVED

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Sharon L Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 12, 2017
• Study Start: July 6, 2017
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)