Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

Completed

• Conditions: Trichomoniasis; Vulvovaginal Candidiasis; Bacterial Vaginosis
• Interventions: Other: NAAT testing

• Registration Number: NCT02203942
• Lead Sponsor: University of Pittsburgh

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).

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-25
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaginal Infections (BV, VVC, trich)	NAAT testing	NAAT testing Amsel criteria Nugent score yeast culture TV culture

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States