Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

Bacterial Vaginosis Clinical Trial

— VAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02203942
• Other study ID #: PRO14010349
• Status: Completed
• Phase: N/A
• First received: July 25, 2014
• Last updated: January 26, 2016
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Candidiasis
• Candidiasis, Vulvovaginal
• Trichomonas Infections
• Trichomoniasis
• Vaginosis, Bacterial
• Vulvovaginal Candidiasis

Intervention

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

Locations

Country	Name	City	State
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Vaginal Infections	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.	approximately 7 days	No