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Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis — VAST  

Bacterial Vaginosis Clinical Trial

Official title:
Comparing NAAT Testing to Standard Methods in Diagnosis of Vaginal Infections in the General Gynecology and Vulvovaginal Referral Offices.

Clinical Trial Summary

Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard.

The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).

Clinical Trial Description

Several commercial nucleic acid amplification tests (NAAT) are available to identify causative organisms. One of these commercial tests has undergone validation published in a scientific journal, only in an STD clinic population. The primary outcome of this study is to compare NAAT diagnostic methods to traditional gold-standard tests for BV, VVC and TV in symptomatic and asymptomatic women in the general gynecology office as well as in a vulvovaginitis referral office. Addressing incorrect evaluation and diagnosis will lead to correct treatment for women suffering from vaginitis. ;

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02203942
Study type Observational
Source University of Pittsburgh
Contact
Status Completed
Phase N/A
Start date July 2014
Completion date June 2015
View Details
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