Comparing NAAT Testing to Standard Methods in Diagnosis of Vaginal Infections in the General Gynecology and Vulvovaginal Referral Offices.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pittsburgh
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Diagnosis of Vaginal Infections
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Harold Wiesenfeld
Associate Professor
University of Pittsburgh