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Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis (VAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02203942
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : January 27, 2016
Information provided by (Responsible Party):
Harold Wiesenfeld, 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).

Condition or disease Intervention/treatment
Bacterial Vaginosis Vulvovaginal Candidiasis Trichomoniasis Other: NAAT testing

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.

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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Case-Only
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

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Enrollments will include patients seeking care at Magee-Womens Hospital.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02203942

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United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
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Principal Investigator: Harold C Wiesenfeld, MD, CM University of Pittsburgh
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Responsible Party: Harold Wiesenfeld, Associate Professor, University of Pittsburgh Identifier: NCT02203942    
Other Study ID Numbers: PRO14010349
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by Harold Wiesenfeld, University of Pittsburgh:
Bacterial Vaginosis
Vulvovaginal Candidiasis
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Candidiasis, Vulvovaginal
Trichomonas Infections
Vaginal Diseases
Bacterial Infections
Vulvar Diseases
Protozoan Infections
Parasitic Diseases