<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/NCT03818477</url>
  </required_header>
  <id_info>
    <org_study_id>21092</org_study_id>
    <secondary_id>PR-18038</secondary_id>
    <nct_id>NCT03818477</nct_id>
  </id_info>
  <brief_title>Environmental Surveillance (ES) for Polio and AMR Using the TaqMan Array Card</brief_title>
  <official_title>Evaluation of TaqMan Array Card for Environmental Surveillance of Polio Virus and Antimicrobial Resistance Genes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</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>
      This study will be used to develop a tool to streamline poliovirus environmental surveillance&#xD;
      for the polio endgame and to provide a tool for detecting polio in places where there is no&#xD;
      capacity to carry out the gold standard culture-based detection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This environmental surveillance tool will also include antimicrobial resistance (AMR) genes&#xD;
      to describe resistome profile in environmental samples and to better inform us of the&#xD;
      potential risks of exposure to these environments&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 9, 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Polymerase Chain Reaction (PCR) detection of poliovirus, enteric pathogens and antimicrobial resistance genes from environmental samples</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Evaluate performance of the TaqMan Array Card (TAC) on environmental samples (sewage samples) collected in urban slum area of Mirpur. The primary purpose will be to use TAC to detect and monitor Sabin 1 and 3 polio viruses post SIA.</description>
  </primary_outcome>
  <enrollment type="Anticipated">8500</enrollment>
  <condition>Polio</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will conduct a Supplementary Immunization Activity (SIA) using bivalent&#xD;
        oral polio vaccine (bOPV) and administer bOPV to at least 70% of all children under the age&#xD;
        of 5 in the participating wards in the urban slums of Mirpur, Dhaka&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  birth-4 years of age&#xD;
&#xD;
          -  reside in selected urban slums of Mirpur Dhaka, Bangladesh&#xD;
&#xD;
          -  receiving bOPV immunization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parent unwilling to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mami Taniuchi</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Centre for Diarrhoeal Disease Research</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>October 1, 2019</last_update_submitted>
  <last_update_submitted_qc>October 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Mami Taniuchi, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</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/NCT03818477
org study id: 21092
secondary id: PR-18038
nct id: NCT03818477
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be used to develop a tool to streamline poliovirus environmental surveillance
      for the polio endgame and to provide a tool for detecting polio in places where there is no
      capacity to carry out the gold standard culture-based detection.
This environmental surveillance tool will also include antimicrobial resistance (AMR) genes
      to describe resistome profile in environmental samples and to better inform us of the
      potential risks of exposure to these environments
observational model: Ecologic or Community
time perspective: Prospective
measure: Polymerase Chain Reaction (PCR) detection of poliovirus, enteric pathogens and antimicrobial resistance genes from environmental samples
time frame: through study completion, an average of 1 year
description: Evaluate performance of the TaqMan Array Card (TAC) on environmental samples (sewage samples) collected in urban slum area of Mirpur. The primary purpose will be to use TAC to detect and monitor Sabin 1 and 3 polio viruses post SIA.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mami Taniuchi
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Mami Taniuchi, PhD
investigator title: Assistant Professor
mesh term: Poliomyelitis
sharing ipd: No