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

University of Pittsburgh

Status: Completed

Conditions: Trichomoniasis; Vulvovaginal Candidiasis; Bacterial Vaginosis

Treatments: Other: NAAT testing

Study type: Observational

Funder types: Other

Identifiers

NCT02203942

PRO14010349

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Female participants aged 18 and older

2. Based on symptoms:

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

3. Willing to provide written informed consent for participation in this study

Exclusion criteria

1. Use of oral antibiotics in the past 14 days
2. Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24 hour

Trial design

300 participants in 1 patient group

Vaginal Infections (BV, VVC, trich)

Description:

NAAT testing Amsel criteria Nugent score yeast culture TV culture

Treatment:

Other: NAAT testing