Diagnostic Accuracy By Providers Study

Completed

Conditions studied: Vaginitis

In brief

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.

Key facts

Study ID

NCT03151928

Run by

University of Pittsburgh

People needed

299

Starts

2017-07-06

Expected to finish

2018-08-15

Last updated by the study team

2018-10-04

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

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.
• Exclusion:
• 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.

Where it is running

• Magee-Womens Hospital of UPMC/associated community clinics — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.