Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis (VAST)
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|ClinicalTrials.gov Identifier: NCT02203942|
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : January 27, 2016
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).
|Condition or disease||Intervention/treatment|
|Bacterial Vaginosis Vulvovaginal Candidiasis Trichomoniasis||Other: NAAT testing|
|Study Type :||Observational|
|Actual Enrollment :||300 participants|
|Official Title:||Comparing NAAT Testing to Standard Methods in Diagnosis of Vaginal Infections in the General Gynecology and Vulvovaginal Referral Offices.|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Vaginal Infections (BV, VVC, trich)
NAAT testing Amsel criteria Nugent score yeast culture TV culture
Other: NAAT testing
comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203942
|United States, Pennsylvania|
|Magee-Womens Hospital of UPMC|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Harold C Wiesenfeld, MD, CM||University of Pittsburgh|