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

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT02203942

Collaborator

(none)

300

Enrollment

Location

Duration (Months)

27.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Bacterial Vaginosis Vulvovaginal Candidiasis Trichomoniasis	Other: NAAT testing

Detailed 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

Study Type:

Observational

Actual Enrollment :

300 participants

Observational Model:

Case-Only

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Vaginal Infections (BV, VVC, trich) NAAT testing Amsel criteria Nugent score yeast culture TV culture	Other: NAAT testing comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.

Arm

Intervention/Treatment

Vaginal Infections (BV, VVC, trich)

NAAT testing Amsel criteria Nugent score yeast culture TV culture

Other: NAAT testing

comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.

Outcome Measures

Primary Outcome Measures

Diagnosis of Vaginal Infections [approximately 7 days]
Compare the sensitivity and specificity of NAAT tests to Amsel criteria, Nugent score for bacterial vaginosis, yeast culture and TV culture in detecting BV, VVC, and trichomoniasis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Female participants aged 18 and older
Based on symptoms:

Symptomatic patients: with symptoms of vaginitis that include abnormal discharge, malodor, itching, irritation and / or discomfort
Asymptomatic controls: no vulvovaginal symptoms