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Trial record 61 of 228 for:    yeast

Diagnostic Accuracy By Providers Study (DAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151928
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
Becton Dickinson Life Sciences
Information provided by (Responsible Party):
Sharon Hillier, 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.

Condition or disease Intervention/treatment
Vaginitis Diagnostic Test: BDMax Vaginal Panel

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.

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Study Type : Observational
Actual Enrollment : 299 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Diagnostic Accuracy By Providers Study
Actual Study Start Date : July 6, 2017
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginitis

Group/Cohort Intervention/treatment
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
The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions
Other Names:
  • Gram Stain/Nuget Criteria
  • yeast culture
  • Trichomonas vaginalis NAAT




Primary Outcome Measures :
  1. BV Result Agreement [ Time Frame: 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

  2. Trichomonas (TV) Result Agreement [ Time Frame: 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

  3. Yeast Result Agreement [ Time Frame: 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 :
  1. Patterns of clinician testing [ Time Frame: enrollment ]
    Description of the patterns of testing among clinicians in the community practice providing care for women presenting with symptoms of vaginitis

  2. Prescribed Treatments [ Time Frame: enrollment ]
    Description of the treatments prescribed for women presenting with vaginitis and how these prescribed treatments are distributed in women with laboratory confirmed diagnoses.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women presenting to primary care offices with symptoms of vaginitis
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151928


Locations
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United States, Pennsylvania
Magee-Womens Hospital of UPMC/associated community clinics
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Becton Dickinson Life Sciences
Investigators
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Principal Investigator: Sharon L Hillier, PhD University of Pittsburgh

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Responsible Party: Sharon Hillier, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03151928     History of Changes
Other Study ID Numbers: PRO17030332
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vaginitis
Vaginal Diseases
Genital Diseases, Female