<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/NCT03251261</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN-DHF-333-001</org_study_id>
    <nct_id>NCT03251261</nct_id>
  </id_info>
  <brief_title>Detection of Cytomegalovirus Virus in Neonates</brief_title>
  <acronym>CMV</acronym>
  <official_title>Illumigene CMV Clinical Trial Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meridian Bioscience, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meridian Bioscience, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of&#xD;
      age) saliva swabs&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">March 5, 2018</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative detection of CMV to aid in the diagnosis of CMV</measure>
    <time_frame>within 30 days of sample collection</time_frame>
    <description>Test each sample for CMV detection</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1615</enrollment>
  <condition>CMV</condition>
  <arm_group>
    <arm_group_label>Specimen collection</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>illumigene CMV assay, illumipro-10</intervention_name>
    <description>CMV assay for detection of CMV</description>
    <arm_group_label>Specimen collection</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Prospectively collected saliva swabs from neonates up to 21 days of age Retrospective well&#xD;
      characterized positive saliva samples will also be tested&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Saliva swab specimens from all neonates up to 21 days of age may be collected and tested&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Saliva swab specimens from neonates up to 21 days of age&#xD;
&#xD;
          -  Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile&#xD;
             tube without medium.&#xD;
&#xD;
          -  Flocked-nylon swabs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Samples other than saliva swab from patients up to 21 days of age.&#xD;
&#xD;
          -  Swabs other than flocked-nylon.&#xD;
&#xD;
          -  Swabs in a viral transport media not defined in the Investigational Use Only package&#xD;
             insert&#xD;
&#xD;
          -  Multiple specimens from the same patient.&#xD;
&#xD;
          -  Specimens received in the laboratory in unsatisfactory containers or condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>20 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julie M Kesler</last_name>
    <role>Study Director</role>
    <affiliation>Meridian Bioscience</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ken Kozak</last_name>
    <role>Study Chair</role>
    <affiliation>Meridian Bioscience</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince of Wales Hospital</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>British Columbia Children's Hospital / British Columbia Women's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Coloumbia</state>
        <zip>V6H 3N1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sant'Orsola</name>
      <address>
        <city>Via Massarenti 19</city>
        <state>Province Of Bologna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Italy</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03251261
org study id: CLIN-DHF-333-001
nct id: NCT03251261
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of
      age) saliva swabs
observational model: Cohort
time perspective: Prospective
measure: Qualitative detection of CMV to aid in the diagnosis of CMV
time frame: within 30 days of sample collection
description: Test each sample for CMV detection
arm group label: Specimen collection
intervention type: Device
intervention name: illumigene CMV assay, illumipro-10
description: CMV assay for detection of CMV
arm group label: Specimen collection
Prospectively collected saliva swabs from neonates up to 21 days of age Retrospective well
      characterized positive saliva samples will also be tested
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 20 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Julie M Kesler
role: Study Director
affiliation: Meridian Bioscience
last name: Ken Kozak
role: Study Chair
affiliation: Meridian Bioscience
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: Italy
country: United States
responsible party type: Sponsor