<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/NCT02200224</url>
  </required_header>
  <id_info>
    <org_study_id>JHUIRB00026782</org_study_id>
    <secondary_id>U54EB007958</secondary_id>
    <nct_id>NCT02200224</nct_id>
  </id_info>
  <brief_title>Clinical Utility of Rapid CT/NG Testing in the ED</brief_title>
  <official_title>Clinical Utility of Rapid CT/NG Testing in the ED</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Biomedical Imaging and Bioengineering (NIBIB)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to:&#xD;
&#xD;
        1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae&#xD;
           (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the&#xD;
           Emergency Department (ED) for a Sexually Transmitted Infection (STI).&#xD;
&#xD;
        2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic&#xD;
           under and over treatment for TV in women evaluated in the ED for an STI&#xD;
&#xD;
        3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria&#xD;
           Gonorrhoeae (NG) and TV testing in the Emergency Department setting.&#xD;
&#xD;
      To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually&#xD;
      Transmitted Infection diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overtreatment rate of CT/NG between the control and interventional groups</measure>
    <time_frame>2 week follow-up</time_frame>
    <description>Overtreatment is defined as CT/NG negative patients who received antibiotic treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Sexually Transmitted Diseases</condition>
  <arm_group>
    <arm_group_label>Rapid Testing/Treatment Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects enrolled in the rapid testing group will receive rapid CT/NG and TV testing in addition to the CT/NG Nucleic Acid Amplification Test (NAAT) and wet mount testing that is currently used in the ED.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All subjects enrolled in the control group will receive CT/NG and TV testing according to the current standard of care for Johns Hopkins ED.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rapid Testing</intervention_name>
    <arm_group_label>Rapid Testing/Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study population includes women between the age of 18 and 50 who present to the ED&#xD;
             and are going to receive CT/NG testing in the ED.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded if they are unable to provide informed consent or are not&#xD;
             English speaking.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Dugas, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>May 6, 2016</last_update_submitted>
  <last_update_submitted_qc>May 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>Rich Rothman</investigator_full_name>
    <investigator_title>Professor, Vice Chair of Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sexually Transmitted Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02200224
org study id: JHUIRB00026782
secondary id: U54EB007958
nct id: NCT02200224
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to:

        1. determine the clinical impact of rapid Chlamydia Trachomatis (CT), Neisseria Gonorrhoeae
           (NG) testing on antibiotic over and under treatment for CT/NG in women evaluated in the
           Emergency Department (ED) for a Sexually Transmitted Infection (STI).

        2. determine the clinical impact of rapid Trichomonas Vaginalis (TV) testing on antibiotic
           under and over treatment for TV in women evaluated in the ED for an STI

        3. evaluate the feasibility of integrating rapid Chlamydia Trachomatis (CT), Neisseria
           Gonorrhoeae (NG) and TV testing in the Emergency Department setting.

      To evaluate the impact or rapid CT/NG/TV testing an patient comprehension of Sexually
      Transmitted Infection diagnosis.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Overtreatment rate of CT/NG between the control and interventional groups
time frame: 2 week follow-up
description: Overtreatment is defined as CT/NG negative patients who received antibiotic treatment.
arm group label: Rapid Testing/Treatment Group
arm group type: Experimental
description: All subjects enrolled in the rapid testing group will receive rapid CT/NG and TV testing in addition to the CT/NG Nucleic Acid Amplification Test (NAAT) and wet mount testing that is currently used in the ED.
arm group label: Control
arm group type: No Intervention
description: All subjects enrolled in the control group will receive CT/NG and TV testing according to the current standard of care for Johns Hopkins ED.
intervention type: Other
intervention name: Rapid Testing
arm group label: Rapid Testing/Treatment Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea Dugas, MD,PhD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: Rich Rothman
investigator title: Professor, Vice Chair of Research
mesh term: Sexually Transmitted Diseases
sharing ipd: No