<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/NCT03037957</url>
  </required_header>
  <id_info>
    <org_study_id>LMA-GAS-01-CS-006</org_study_id>
    <nct_id>NCT03037957</nct_id>
  </id_info>
  <brief_title>A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients</brief_title>
  <official_title>A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Luminex Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Luminex Molecular Diagnostics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES&#xD;
      Group A Strep Assay will be established through a method comparison using prospectively&#xD;
      collected, de-identified, clinical samples collected during the enrollment period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2017</start_date>
  <completion_date type="Actual">June 2, 2017</completion_date>
  <primary_completion_date type="Actual">June 2, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical performance (sensitivity/specificity) for Group A Strep Assay</measure>
    <time_frame>Day 1</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">704</enrollment>
  <condition>Pharyngitis Bacterial</condition>
  <arm_group>
    <arm_group_label>Group A Strep Assay</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ARIES Group A Strep Assay</intervention_name>
    <arm_group_label>Group A Strep Assay</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered&#xD;
        a Group A Strep test.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient and/or patient's legal guardian is willing and able to give informed consent&#xD;
             and/or assent for extra research sample.&#xD;
&#xD;
          -  The subject's specimen is a throat swab in Liquid Amies based transport medium.&#xD;
&#xD;
          -  The specimen is from an adult or pediatric, male or female subject who is either&#xD;
             hospitalized, admitted to a hospital emergency department, visiting an outpatient&#xD;
             clinical or resident of a long term care facility.&#xD;
&#xD;
          -  The specimen is from a patient for whom a requisition has been made for Group A Strep&#xD;
             testing&#xD;
&#xD;
          -  The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis&#xD;
             consistent with Group A Strep infection.&#xD;
&#xD;
          -  The specimen was received in good condition (no leakage or drying of the specimen).&#xD;
&#xD;
          -  The specimen volume is ≥ 850 µL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The specimen is from a patient who did not provide informed consent/assent.&#xD;
&#xD;
          -  The specimen is not a throat swab collected in Liquid Amies based transport medium.&#xD;
&#xD;
          -  The specimen is from a patient who is undergoing antibiotic treatment.&#xD;
&#xD;
          -  The specimen was not properly collected, transported, processed or stored according to&#xD;
             the instructions provided by the Sponsor in Section 9 below.&#xD;
&#xD;
          -  The specimen volume is &lt; 850 µL.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald Dunn</last_name>
    <role>Study Director</role>
    <affiliation>Luminex Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacred Heart Hospital</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Pediatrics Research</name>
      <address>
        <city>Vienna</city>
        <state>Virginia</state>
        <zip>22180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Labs</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>July 5, 2017</last_update_submitted>
  <last_update_submitted_qc>July 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</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/NCT03037957
org study id: LMA-GAS-01-CS-006
nct id: NCT03037957
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES
      Group A Strep Assay will be established through a method comparison using prospectively
      collected, de-identified, clinical samples collected during the enrollment period.
observational model: Case-Only
time perspective: Prospective
measure: Clinical performance (sensitivity/specificity) for Group A Strep Assay
time frame: Day 1
arm group label: Group A Strep Assay
intervention type: Device
intervention name: ARIES Group A Strep Assay
arm group label: Group A Strep Assay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ronald Dunn
role: Study Director
affiliation: Luminex Corporation
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pharyngitis