<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/NCT01683630</url>
  </required_header>
  <id_info>
    <org_study_id>ICID-2012-FLU-A,B-02</org_study_id>
    <nct_id>NCT01683630</nct_id>
  </id_info>
  <brief_title>Comparison of Epidemiology and Clinical Outcomes of Influenza A &amp; B Cases in Manitoba, Canada</brief_title>
  <official_title>Comparison of the Epidemiology and Clinical Outcomes of Laboratory-Confirmed Influenza A and Influenza B Cases in Manitoba, Canada</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>International Centre for Infectious Diseases, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>International Centre for Infectious Diseases, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza&#xD;
      type A to type B following clinical diagnosis of influenza. Multivariate models are used to&#xD;
      assess the effects of influenza type on clinical outcomes while accounting for potential&#xD;
      confounders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Annual epidemics of influenza are an important public health problem globally and in Canada.&#xD;
      Each year, 10-25% of the Canadian population become infected with influenza. Most of these&#xD;
      infections are typically asymptomatic or associated with a mild self-limiting illness.&#xD;
      However, influenza can cause severe illness leading to hospitalization and death, especially&#xD;
      among the very young, the elderly and among those with underlying chronic conditions. It has&#xD;
      been estimated that on average about 4,000 influenza-related deaths occur in Canada each&#xD;
      year. In addition, the economic burden of influenza is significant because of the high direct&#xD;
      costs associated with increased utilization of services and the indirect costs caused by&#xD;
      school and work absenteeism.&#xD;
&#xD;
      This project compares laboratory-confirmed cases of influenza A and B in terms of their&#xD;
      epidemiology, and the overall and cause-specific incidence rates of important clinical&#xD;
      outcomes including physician visits, hospitalization and death following clinical diagnosis&#xD;
      of influenza cases in Manitoba over the period from 1993 to 2008.&#xD;
&#xD;
      The study assesses secular and seasonal trends in the incidence rates of influenza A and B&#xD;
      cases in Manitoba during the period of 1993-2008, to determine whether these rates vary for&#xD;
      different subsets of the population defined by demographic (e.g., age group, gender),&#xD;
      socioeconomic, geographic (neighborhood of residence) and clinical (e.g., vaccination,&#xD;
      presence of chronic conditions, immune status) characteristics.&#xD;
&#xD;
      The analysis by influenza type then compares the overall and cause-specific incidence rates&#xD;
      of physician visits, hospitalization and death following the diagnosis of a&#xD;
      laboratory-confirmed influenza. The effects of influenza type on clinical outcomes (e.g.,&#xD;
      hospitalization) are assessed with multivariate models while accounting for potential&#xD;
      confounding by demographic, socioeconomic, geographic and clinical (e.g., co-morbidity,&#xD;
      immune status) characteristics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba</measure>
    <time_frame>up to 15 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba</measure>
    <time_frame>upto 15 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba</measure>
    <time_frame>Upto 15 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1849</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Confirmed influenza A and B cases</arm_group_label>
    <description>Cases of influenza A and B as diagnosed by PCR, viral culture or florescence microscopy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Any person who normally resides in Manitoba and who has been continuously covered during&#xD;
        the study period will be eligible for inclusion in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any person who normally resides in Manitoba and who has been continuously covered by&#xD;
             Manitoba Health during the study period will be eligible for inclusion in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Salah Mahmud, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate Professor, University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Centre for Infectious Diseases</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3B 3P5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Hinds AM, Bozat-Emre S, Van Caeseele P, Mahmud SM. Comparison of the epidemiology of laboratory-confirmed influenza A and influenza B cases in Manitoba, Canada. BMC Public Health. 2015 Jan 30;15:35. doi: 10.1186/s12889-015-1351-z.</citation>
    <PMID>25633280</PMID>
  </results_reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>June 30, 2015</results_first_submitted>
  <results_first_submitted_qc>September 25, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 19, 2015</results_first_posted>
  <last_update_submitted>August 29, 2016</last_update_submitted>
  <last_update_submitted_qc>August 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Influenza type A</keyword>
  <keyword>Influenza type B</keyword>
  <keyword>hospitalization</keyword>
  <keyword>Manitoba</keyword>
  <keyword>Canada</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Confirmed Cases of Influenza A</title>
          <description>Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy</description>
        </group>
        <group group_id="P2">
          <title>Confirmed Cases of Influenza B</title>
          <description>Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1404"/>
                <participants group_id="P2" count="445"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1404"/>
                <participants group_id="P2" count="445"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Confirmed Cases of Influenza A</title>
          <description>Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy</description>
        </group>
        <group group_id="B2">
          <title>Confirmed Cases of Influenza B</title>
          <description>Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy</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="1404"/>
            <count group_id="B2" value="445"/>
            <count group_id="B3" value="1849"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="511"/>
                    <measurement group_id="B2" value="236"/>
                    <measurement group_id="B3" value="747"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="325"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="454"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="568"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="758"/>
                    <measurement group_id="B2" value="245"/>
                    <measurement group_id="B3" value="1003"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="646"/>
                    <measurement group_id="B2" value="200"/>
                    <measurement group_id="B3" value="846"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1404"/>
                    <measurement group_id="B2" value="445"/>
                    <measurement group_id="B3" value="1849"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba</title>
        <time_frame>up to 15 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Confirmed Cases of Influenza A</title>
            <description>Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy</description>
          </group>
          <group group_id="O2">
            <title>Confirmed Cases of Influenza B</title>
            <description>Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy</description>
          </group>
        </group_list>
        <measure>
          <title>Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba</title>
          <units>Percentage of participants</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="1404"/>
                <count group_id="O2" value="445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5" lower_limit="22.2" upper_limit="24.8"/>
                    <measurement group_id="O2" value="22.1" lower_limit="20.1" upper_limit="24.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba</title>
        <time_frame>upto 15 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Confirmed Cases of Influenza A</title>
            <description>Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy</description>
          </group>
          <group group_id="O2">
            <title>Confirmed Cases of Influenza B</title>
            <description>Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1404"/>
                <count group_id="O2" value="445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0"/>
                    <measurement group_id="O2" value="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba</title>
        <time_frame>Upto 15 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Confirmed Cases of Influenza A</title>
            <description>Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy</description>
          </group>
          <group group_id="O2">
            <title>Confirmed Cases of Influenza B</title>
            <description>Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy</description>
          </group>
        </group_list>
        <measure>
          <title>Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba</title>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1404"/>
                <count group_id="O2" value="445"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5"/>
                    <measurement group_id="O2" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>0 months</time_frame>
      <desc>Serious and other Adverse Events were not collected/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Confirmed Cases of Influenza A</title>
          <description>Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy</description>
        </group>
        <group group_id="E2">
          <title>Confirmed Cases of Influenza B</title>
          <description>Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Salah Mahmud</name_or_title>
      <organization>Unversity of Manotiba</organization>
      <phone>204-272-3139</phone>
      <email>salah.mahmud@umanitoba.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/NCT01683630
org study id: ICID-2012-FLU-A,B-02
nct id: NCT01683630
lead sponsor: 
has dmc: No
This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza
      type A to type B following clinical diagnosis of influenza. Multivariate models are used to
      assess the effects of influenza type on clinical outcomes while accounting for potential
      confounders.
Annual epidemics of influenza are an important public health problem globally and in Canada.
      Each year, 10-25% of the Canadian population become infected with influenza. Most of these
      infections are typically asymptomatic or associated with a mild self-limiting illness.
      However, influenza can cause severe illness leading to hospitalization and death, especially
      among the very young, the elderly and among those with underlying chronic conditions. It has
      been estimated that on average about 4,000 influenza-related deaths occur in Canada each
      year. In addition, the economic burden of influenza is significant because of the high direct
      costs associated with increased utilization of services and the indirect costs caused by
      school and work absenteeism.

      This project compares laboratory-confirmed cases of influenza A and B in terms of their
      epidemiology, and the overall and cause-specific incidence rates of important clinical
      outcomes including physician visits, hospitalization and death following clinical diagnosis
      of influenza cases in Manitoba over the period from 1993 to 2008.

      The study assesses secular and seasonal trends in the incidence rates of influenza A and B
      cases in Manitoba during the period of 1993-2008, to determine whether these rates vary for
      different subsets of the population defined by demographic (e.g., age group, gender),
      socioeconomic, geographic (neighborhood of residence) and clinical (e.g., vaccination,
      presence of chronic conditions, immune status) characteristics.

      The analysis by influenza type then compares the overall and cause-specific incidence rates
      of physician visits, hospitalization and death following the diagnosis of a
      laboratory-confirmed influenza. The effects of influenza type on clinical outcomes (e.g.,
      hospitalization) are assessed with multivariate models while accounting for potential
      confounding by demographic, socioeconomic, geographic and clinical (e.g., co-morbidity,
      immune status) characteristics.
observational model: Cohort
time perspective: Retrospective
measure: Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba
time frame: up to 15 years
measure: Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba
time frame: upto 15 years
measure: Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba
time frame: Upto 15 years
arm group label: Confirmed influenza A and B cases
description: Cases of influenza A and B as diagnosed by PCR, viral culture or florescence microscopy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: No
last name: Salah Mahmud, MD, PhD
role: Principal Investigator
affiliation: Associate Professor, University of Manitoba
facility: 
country: Canada
citation: Hinds AM, Bozat-Emre S, Van Caeseele P, Mahmud SM. Comparison of the epidemiology of laboratory-confirmed influenza A and influenza B cases in Manitoba, Canada. BMC Public Health. 2015 Jan 30;15:35. doi: 10.1186/s12889-015-1351-z.
PMID: 25633280
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 