<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/NCT01662362</url>
  </required_header>
  <id_info>
    <org_study_id>7B5-02-10P02-01</org_study_id>
    <nct_id>NCT01662362</nct_id>
  </id_info>
  <brief_title>Abbott ESA Chagas Assay Post-Market Study</brief_title>
  <acronym>ESA</acronym>
  <official_title>Abbott ESA Chagas Assay Post-Market Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Diagnostics Division</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Diagnostics Division</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is conducted to meet an FDA post market commitment to collect and report data on&#xD;
      the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are&#xD;
      FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA&#xD;
      Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified&#xD;
      donor specimens will be tested with ABBOTT ESA Chagas assay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ABBOTT ESA Chagas testing will be performed at a minimum of two blood donor centers. Testing&#xD;
      will be performed using the FDA-licensed ESA Chagas assay and will be performed in accordance&#xD;
      with the ESA Chagas package insert. ABBOTT PRISM Chagas repeatedly reactive blood donor&#xD;
      specimens identified by U.S. blood donor centers, as part of the routine blood donation&#xD;
      process, will be tested with the FDA-licensed ESA Chagas. Specimens will also be tested with&#xD;
      radioimmune precipitation assay (RIPA) for antibody to T. cruzi, a laboratory developed test,&#xD;
      and the FDA-licensed ORTHO T. cruzi ELISA. The donor centers will contact the donors and&#xD;
      request the donor to return to complete a questionnaire and provide a follow-up specimen.&#xD;
&#xD;
      In addition, a minimum of 300 blood donor specimens with ABBOTT PRISM Chagas nonreactive&#xD;
      results will also be tested with ESA Chagas. These specimens will be unidentified, leftover&#xD;
      specimens from routine donor testing and not individually identifiable. Specimens that are&#xD;
      positive or indeterminate with ESA Chagas will be further tested with RIPA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas</measure>
    <time_frame>Up to six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas</measure>
    <time_frame>Up to six months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Chagas Disease</condition>
  <arm_group>
    <arm_group_label>Testing Donor Specimens with ESA Chagas</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Testing Donor Specimens with ESA Chagas</intervention_name>
    <description>Donors will be asked to return for a follow-up blood draw.</description>
    <arm_group_label>Testing Donor Specimens with ESA Chagas</arm_group_label>
    <other_name>ABBOTT ESA Chagas (ESA Chagas) assay</other_name>
    <other_name>List Number: 8L34</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PRISM Chagas Repeatedly Reactive Donor Specimens&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Blood donor specimen documented as PRISM Chagas repeatedly reactive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Stramer, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>American National Red Cross</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sharon Gordon, MS, MBA, MT</last_name>
    <role>Principal Investigator</role>
    <affiliation>LifeSource</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LifeSource</name>
      <address>
        <city>Rosemont</city>
        <state>Illinois</state>
        <zip>60018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Red Cross</name>
      <address>
        <city>Gaithersburg</city>
        <state>Maryland</state>
        <zip>20877</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>January 8, 2014</results_first_submitted>
  <results_first_submitted_qc>January 8, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 20, 2014</results_first_posted>
  <last_update_submitted>January 8, 2014</last_update_submitted>
  <last_update_submitted_qc>January 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chagas Disease</keyword>
  <keyword>Trypanosoma cruzi</keyword>
  <keyword>American trypanosomiasis</keyword>
  <keyword>South American trypanosomiasis</keyword>
  <keyword>kissing bugs</keyword>
  <keyword>reduviid bugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chagas Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Testing Donor Specimens With ESA Chagas</title>
          <description>Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.&#xD;
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Donor specimens PRISM Chagas Repeatly Reactive</population>
      <group_list>
        <group group_id="B1">
          <title>Testing Donor Specimens With ESA Chagas</title>
          <description>Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.&#xD;
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="63"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Routine whole blood donors</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&gt;= 18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas</title>
        <time_frame>Up to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Testing Donor Specimens With ESA Chagas</title>
            <description>Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.&#xD;
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.</description>
          </group>
        </group_list>
        <measure>
          <title>ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas</title>
          <units>percent agreement to RIPA</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.06" lower_limit="82.44" upper_limit="97.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas</title>
        <time_frame>Up to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Testing Donor Specimens With ESA Chagas</title>
            <description>Test blood donor specimens that are ABBOTT PRISM Chagas Nonreactive with ESA Chagas. These specimens will be unidentified specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.</description>
          </group>
        </group_list>
        <measure>
          <title>ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas</title>
          <units>percentage of specimens ESA negative</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.00" lower_limit="97.11" upper_limit="99.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Testing Donor Specimens With ESA Chagas</title>
          <description>Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.&#xD;
Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Barbara Kaesdorf, Associate Director Clinical Affairs</name_or_title>
      <organization>Abbott</organization>
      <phone>847-937-8702</phone>
      <email>barbara.kaesdorf@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01662362
org study id: 7B5-02-10P02-01
nct id: NCT01662362
lead sponsor: 
has dmc: No
The study is conducted to meet an FDA post market commitment to collect and report data on
      the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are
      FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA
      Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified
      donor specimens will be tested with ABBOTT ESA Chagas assay.
ABBOTT ESA Chagas testing will be performed at a minimum of two blood donor centers. Testing
      will be performed using the FDA-licensed ESA Chagas assay and will be performed in accordance
      with the ESA Chagas package insert. ABBOTT PRISM Chagas repeatedly reactive blood donor
      specimens identified by U.S. blood donor centers, as part of the routine blood donation
      process, will be tested with the FDA-licensed ESA Chagas. Specimens will also be tested with
      radioimmune precipitation assay (RIPA) for antibody to T. cruzi, a laboratory developed test,
      and the FDA-licensed ORTHO T. cruzi ELISA. The donor centers will contact the donors and
      request the donor to return to complete a questionnaire and provide a follow-up specimen.

      In addition, a minimum of 300 blood donor specimens with ABBOTT PRISM Chagas nonreactive
      results will also be tested with ESA Chagas. These specimens will be unidentified, leftover
      specimens from routine donor testing and not individually identifiable. Specimens that are
      positive or indeterminate with ESA Chagas will be further tested with RIPA.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas
time frame: Up to six months
measure: ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas
time frame: Up to six months
arm group label: Testing Donor Specimens with ESA Chagas
arm group type: Other
description: Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.
intervention type: Device
intervention name: Testing Donor Specimens with ESA Chagas
description: Donors will be asked to return for a follow-up blood draw.
arm group label: Testing Donor Specimens with ESA Chagas
other name: ABBOTT ESA Chagas (ESA Chagas) assay
other name: List Number: 8L34
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Stramer, Ph.D.
role: Principal Investigator
affiliation: American National Red Cross
last name: Sharon Gordon, MS, MBA, MT
role: Principal Investigator
affiliation: LifeSource
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chagas Disease
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 