<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203942</url>
  </required_header>
  <id_info>
    <org_study_id>PRO14010349</org_study_id>
    <nct_id>NCT02203942</nct_id>
  </id_info>
  <brief_title>Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis</brief_title>
  <acronym>VAST</acronym>
  <official_title>Comparing NAAT Testing to Standard Methods in Diagnosis of Vaginal Infections in the General Gynecology and Vulvovaginal Referral Offices.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Vaginitis is the most common condition encountered in the gynecologist's office and is most&#xD;
      commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas&#xD;
      vaginalis (TV). Establishing the correct etiology of symptomatic vaginitis can be&#xD;
      challenging, and the evaluation of vaginitis by physicians is often substandard.&#xD;
&#xD;
      The investigators will determine whether NAAT testing will improve the diagnosis of vaginal&#xD;
      infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas&#xD;
      vaginalis (TV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several commercial nucleic acid amplification tests (NAAT) are available to identify&#xD;
      causative organisms. One of these commercial tests has undergone validation published in a&#xD;
      scientific journal, only in an STD clinic population. The primary outcome of this study is to&#xD;
      compare NAAT diagnostic methods to traditional gold-standard tests for BV, VVC and TV in&#xD;
      symptomatic and asymptomatic women in the general gynecology office as well as in a&#xD;
      vulvovaginitis referral office. Addressing incorrect evaluation and diagnosis will lead to&#xD;
      correct treatment for women suffering from vaginitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnosis of Vaginal Infections</measure>
    <time_frame>approximately 7 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Bacterial Vaginosis</condition>
  <condition>Vulvovaginal Candidiasis</condition>
  <condition>Trichomoniasis</condition>
  <arm_group>
    <arm_group_label>Vaginal Infections (BV, VVC, trich)</arm_group_label>
    <description>NAAT testing Amsel criteria Nugent score yeast culture TV culture</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NAAT testing</intervention_name>
    <description>comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.</description>
    <arm_group_label>Vaginal Infections (BV, VVC, trich)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Enrollments will include patients seeking care at Magee-Womens Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female participants aged 18 and older&#xD;
&#xD;
          2. Based on symptoms:&#xD;
&#xD;
               -  Symptomatic patients: with symptoms of vaginitis that include abnormal discharge,&#xD;
                  malodor, itching, irritation and / or discomfort&#xD;
&#xD;
               -  Asymptomatic controls: no vulvovaginal symptoms&#xD;
&#xD;
          3. Willing to provide written informed consent for participation in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of oral antibiotics in the past 14 days&#xD;
&#xD;
          2. Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24&#xD;
             hour&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harold C Wiesenfeld, MD, CM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Magee-Womens Hospital of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>January 26, 2016</last_update_submitted>
  <last_update_submitted_qc>January 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Harold Wiesenfeld</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Bacterial Vaginosis</keyword>
  <keyword>Vulvovaginal Candidiasis</keyword>
  <keyword>Trichomoniasis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Candidiasis</mesh_term>
    <mesh_term>Vaginosis, Bacterial</mesh_term>
    <mesh_term>Candidiasis, Vulvovaginal</mesh_term>
    <mesh_term>Trichomonas Infections</mesh_term>
    <mesh_term>Vaginal Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203942
org study id: PRO14010349
nct id: NCT02203942
lead sponsor: 
has dmc: No
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).
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.
observational model: Case-Only
measure: Diagnosis of Vaginal Infections
time frame: approximately 7 days
description: 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.
arm group label: Vaginal Infections (BV, VVC, trich)
description: NAAT testing Amsel criteria Nugent score yeast culture TV culture
intervention type: Other
intervention name: NAAT testing
description: comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.
arm group label: Vaginal Infections (BV, VVC, trich)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Harold C Wiesenfeld, MD, CM
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Harold Wiesenfeld
investigator title: Associate Professor
mesh term: Candidiasis
mesh term: Vaginosis, Bacterial
mesh term: Candidiasis, Vulvovaginal
mesh term: Trichomonas Infections
mesh term: Vaginal Diseases