<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/NCT02968758</url>
  </required_header>
  <id_info>
    <org_study_id>GenePOC CDiff_clinical-01</org_study_id>
    <nct_id>NCT02968758</nct_id>
  </id_info>
  <brief_title>Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains</brief_title>
  <official_title>Prospective Multi-Center Study for Clinical Validation of the Molecular-Based GenePOC CDiff System for the Detection of Toxin B Gene From Toxigenic Clostridium Difficile Strains in Unformed (Soft or Liquid) Human Stool Specimens</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this clinical investigation is to verify the performance of the&#xD;
      GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC&#xD;
      CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a&#xD;
      conventional method considered as gold standard for detection of toxigenic Clostridium&#xD;
      difficile in stool specimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro&#xD;
      diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase&#xD;
      chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile&#xD;
      (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected&#xD;
      of having C. difficile infection (CDI).&#xD;
&#xD;
      The GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which&#xD;
      consists of:&#xD;
&#xD;
        1. Transfer Loop (TL)&#xD;
&#xD;
        2. CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs&#xD;
           because of the shape of the cartridge)&#xD;
&#xD;
        3. CDiff Sample Buffer Tube (SBT)&#xD;
&#xD;
        4. Disposable Transfer Tool (DTT).&#xD;
&#xD;
      The GenePOC Instrument is fully automated and integrates sample lysis, dilution,&#xD;
      amplification and detection of the target sequence in complex samples using real-time&#xD;
      Polymerase chain reaction (rtPCR). User intervention is only required for discharging the&#xD;
      patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and&#xD;
      for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a&#xD;
      rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly&#xD;
      interface, two barcode readers, and integrated firmware and software to deliver results to&#xD;
      the user. The PIE is a closed system that prevents the risk of contamination.&#xD;
&#xD;
      An unformed (soft or liquid) stool specimen is collected using standard stool collection&#xD;
      device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized&#xD;
      stool specimen, stool material is transferred into SBT and vortexed. Sample is then&#xD;
      transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed&#xD;
      by the GenePOC Instrument. On completion of a run, the user removes the processed PIEs from&#xD;
      the instrument and discards them according to local biological waste management procedures.&#xD;
&#xD;
      One GenePOC instrument per site will be allocated. The purpose of the clinical investigation&#xD;
      is to enroll sufficient specimens from up to 7 Clinical Centers to obtain a total of 150&#xD;
      specimens positive for CDiff based on the Reference Method final result.&#xD;
&#xD;
      Subject Informed consent is not required for this clinical trial as the testing will be&#xD;
      performed on excess de-identified specimens only.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">August 10, 2017</completion_date>
  <primary_completion_date type="Actual">August 2, 2017</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method</measure>
    <time_frame>At the time of the results with Reference Method is confirmed, up to 3 months</time_frame>
    <description>To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI).&#xD;
Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.&#xD;
Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Predictive Values (PPV and NPV)</measure>
    <time_frame>At the time of the results with Reference Method is confirmed, up to 3 months</time_frame>
    <description>To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System.&#xD;
PPV is the percentage of true positives out of all positive results (true positive/true positive + false positive).&#xD;
NPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unresolved Sample Results</measure>
    <time_frame>At the time of the results with Reference Method is confirmed, up to 3 months</time_frame>
    <description>To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indeterminate Sample Results</measure>
    <time_frame>At the time of the results with Reference Method is confirmed, up to 3 months</time_frame>
    <description>To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2461</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>Accuracy Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparison between GenePOC PCR and Reference Method</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Comparison between GenePOC PCR and Reference Method</intervention_name>
    <description>Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
    <arm_group_label>Accuracy Testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unformed Stool specimens from patients suspected of having CDI for whom diagnostic&#xD;
             tests are indicated and ordered;&#xD;
&#xD;
          -  At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of&#xD;
             its container);&#xD;
&#xD;
          -  Only one (1) specimen per patient will be included in the study;&#xD;
&#xD;
          -  Materials use within their expiration date;&#xD;
&#xD;
          -  Transport, storage times, and conditions (e.g. room temperature and/or refrigerated)&#xD;
             within requested indications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Specimens from patients for whom CDI diagnostic tests have not been ordered;&#xD;
&#xD;
          -  Transport and storage times and conditions that exceed these Study Protocol&#xD;
             requirements;&#xD;
&#xD;
          -  Formed or hard stool specimens or rectal swabs.&#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>Patrice Allibert</last_name>
    <role>Study Director</role>
    <affiliation>Meridian Bioscience, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wishard Health Services</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detroit Medical Center University Laboratories</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tricore Laboratory University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <results_first_submitted>October 16, 2018</results_first_submitted>
  <results_first_submitted_qc>January 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2019</results_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</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>Clostridium Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT02968758/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Accuracy Testing - Fresh Specimen</title>
          <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
        </group>
        <group group_id="P2">
          <title>Accuracy Testing - Frozen Specimen</title>
          <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="797"/>
                <participants group_id="P2" count="1664"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="797"/>
                <participants group_id="P2" count="1664"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>all specimens were included</population>
      <group_list>
        <group group_id="B1">
          <title>Accuracy Testing - Fresh Specimen</title>
          <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
        </group>
        <group group_id="B2">
          <title>Accuracy Testing - Frozen Specimen</title>
          <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="797"/>
            <count group_id="B2" value="1664"/>
            <count group_id="B3" value="2461"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="797"/>
                    <count group_id="B2" value="1664"/>
                    <count group_id="B3" value="2461"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="399"/>
                    <measurement group_id="B2" value="800"/>
                    <measurement group_id="B3" value="1199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="364"/>
                    <measurement group_id="B2" value="784"/>
                    <measurement group_id="B3" value="1148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <population>Gender information was not collected during the trial.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>All Genders</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="797"/>
                    <count group_id="B2" value="1664"/>
                    <count group_id="B3" value="2461"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="797"/>
                    <count group_id="B2" value="1664"/>
                    <count group_id="B3" value="2461"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="718"/>
                    <measurement group_id="B2" value="1664"/>
                    <measurement group_id="B3" value="2382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method</title>
        <description>To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI).&#xD;
Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.&#xD;
Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.</description>
        <time_frame>At the time of the results with Reference Method is confirmed, up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Accuracy Testing - Fresh Specimen</title>
            <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
          </group>
          <group group_id="O2">
            <title>Accuracy Testing - Frozen Specimen</title>
            <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
          </group>
        </group_list>
        <measure>
          <title>Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method</title>
          <description>To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI).&#xD;
Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.&#xD;
Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.</description>
          <units>percentage of specimens</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="797"/>
                <count group_id="O2" value="1664"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sensitivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5" lower_limit="87.3" upper_limit="99.1"/>
                    <measurement group_id="O2" value="95.2" lower_limit="90.8" upper_limit="97.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.4" lower_limit="91.4" upper_limit="95.1"/>
                    <measurement group_id="O2" value="95.3" lower_limit="94.1" upper_limit="96.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive and Negative Predictive Values (PPV and NPV)</title>
        <description>To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System.&#xD;
PPV is the percentage of true positives out of all positive results (true positive/true positive + false positive).&#xD;
NPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).</description>
        <time_frame>At the time of the results with Reference Method is confirmed, up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Accuracy Testing - Fresh Specimen</title>
            <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
          </group>
          <group group_id="O2">
            <title>Accuracy Testing - Frozen Specimen</title>
            <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive and Negative Predictive Values (PPV and NPV)</title>
          <description>To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System.&#xD;
PPV is the percentage of true positives out of all positive results (true positive/true positive + false positive).&#xD;
NPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).</description>
          <units>percentage of specimens</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="797"/>
                <count group_id="O2" value="1664"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PPV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0" lower_limit="73.6" upper_limit="88.6"/>
                    <measurement group_id="O2" value="83.1" lower_limit="77.7" upper_limit="87.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NPV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="95.2" upper_limit="98.0"/>
                    <measurement group_id="O2" value="98.0" lower_limit="97.2" upper_limit="98.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Unresolved Sample Results</title>
        <description>To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).</description>
        <time_frame>At the time of the results with Reference Method is confirmed, up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Accuracy Testing - Fresh Specimen</title>
            <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
          </group>
          <group group_id="O2">
            <title>Accuracy Testing - Frozen Specimen</title>
            <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
          </group>
        </group_list>
        <measure>
          <title>Unresolved Sample Results</title>
          <description>To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).</description>
          <units>percentage of Unresolved</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="797"/>
                <count group_id="O2" value="1664"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.52" upper_limit="2.13"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.42" upper_limit="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Indeterminate Sample Results</title>
        <description>To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).</description>
        <time_frame>At the time of the results with Reference Method is confirmed, up to 3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Accuracy Testing - Fresh Specimen</title>
            <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Fresh Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
          </group>
          <group group_id="O2">
            <title>Accuracy Testing - Frozen Specimen</title>
            <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Frozen Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
          </group>
        </group_list>
        <measure>
          <title>Indeterminate Sample Results</title>
          <description>To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).</description>
          <units>percentage of Indeterminates</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="797"/>
                <count group_id="O2" value="1664"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" lower_limit="1.16" upper_limit="2.20"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.78" upper_limit="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event were assessed at the time of individual patient enrollment and participation, which lasts approximately 1-2 minutes at most.</time_frame>
      <desc>Adverse event procedures were established at each site, but no adverse event was observed nor reported during the enrollment period.</desc>
      <group_list>
        <group group_id="E1">
          <title>Accuracy Testing</title>
          <description>Comparison between GenePOC PCR and Reference Method&#xD;
Comparison between GenePOC PCR and Reference Method: Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2461"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2461"/>
              </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="2461"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Keith Chiasson, PhD</name_or_title>
      <organization>GenePOC</organization>
      <phone>418-650-3535 ext 322</phone>
      <email>keith.chiasson@genepoc.ca</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/NCT02968758
org study id: GenePOC CDiff_clinical-01
nct id: NCT02968758
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The primary purpose of this clinical investigation is to verify the performance of the
      GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC
      CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a
      conventional method considered as gold standard for detection of toxigenic Clostridium
      difficile in stool specimens.
The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro
      diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase
      chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile
      (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected
      of having C. difficile infection (CDI).

      The GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which
      consists of:

        1. Transfer Loop (TL)

        2. CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs
           because of the shape of the cartridge)

        3. CDiff Sample Buffer Tube (SBT)

        4. Disposable Transfer Tool (DTT).

      The GenePOC Instrument is fully automated and integrates sample lysis, dilution,
      amplification and detection of the target sequence in complex samples using real-time
      Polymerase chain reaction (rtPCR). User intervention is only required for discharging the
      patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and
      for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a
      rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly
      interface, two barcode readers, and integrated firmware and software to deliver results to
      the user. The PIE is a closed system that prevents the risk of contamination.

      An unformed (soft or liquid) stool specimen is collected using standard stool collection
      device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized
      stool specimen, stool material is transferred into SBT and vortexed. Sample is then
      transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed
      by the GenePOC Instrument. On completion of a run, the user removes the processed PIEs from
      the instrument and discards them according to local biological waste management procedures.

      One GenePOC instrument per site will be allocated. The purpose of the clinical investigation
      is to enroll sufficient specimens from up to 7 Clinical Centers to obtain a total of 150
      specimens positive for CDiff based on the Reference Method final result.

      Subject Informed consent is not required for this clinical trial as the testing will be
      performed on excess de-identified specimens only.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method
time frame: At the time of the results with Reference Method is confirmed, up to 3 months
description: To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI).
Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.
Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.
measure: Positive and Negative Predictive Values (PPV and NPV)
time frame: At the time of the results with Reference Method is confirmed, up to 3 months
description: To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System.
PPV is the percentage of true positives out of all positive results (true positive/true positive + false positive).
NPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).
measure: Unresolved Sample Results
time frame: At the time of the results with Reference Method is confirmed, up to 3 months
description: To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).
measure: Indeterminate Sample Results
time frame: At the time of the results with Reference Method is confirmed, up to 3 months
description: To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).
arm group label: Accuracy Testing
arm group type: Experimental
description: Comparison between GenePOC PCR and Reference Method
intervention type: Device
intervention name: Comparison between GenePOC PCR and Reference Method
description: Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.
arm group label: Accuracy Testing
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Patrice Allibert
role: Study Director
affiliation: Meridian Bioscience, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Clostridium Infections
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 