Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

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).

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Parasitic Diseases Protozoan Infections Trichomonas Infections Trichomoniasis Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial Vulvar Diseases Vulvitis Vulvovaginal Candidiasis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
Willing to provide written informed consent for participation in this study

Exclusion criteria

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

Treatment and study plan

NAAT testing

Other

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

Primary outcomes

Diagnosis of Vaginal Infections

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Acronym: VAST

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jul 30, 2014
Registry last updated: Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed