Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Bacterial Vaginosis Vulvovaginal Candidiasis Trichomoniasis

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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Vaginal Infections (BV, VVC, trich)

NAAT testing Amsel criteria Nugent score yeast culture TV culture

NAAT testing

Intervention Type OTHER

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

Interventions

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NAAT testing

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

Intervention Type OTHER

Eligibility Criteria

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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