<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/NCT02260596</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00056727</org_study_id>
    <nct_id>NCT02260596</nct_id>
  </id_info>
  <brief_title>Respiratory Viral Infections in Pediatric Transplantation</brief_title>
  <official_title>A Multicenter Consortium to Define the Epidemiology and Outcomes of Respiratory Viral Infections in Pediatric Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Albert Einstein College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell transplant&#xD;
      (HSCT) recipients will be assembled to determine the incidence of respiratory viral&#xD;
      infections diagnosed during an inpatient admission in the first year post-transplant. A&#xD;
      sub-cohort of patients that develop a respiratory viral infection within one year of&#xD;
      transplantation will be leveraged to investigate factors associated with mortality in the&#xD;
      three months after respiratory viral infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to 1) Determine the incidence of respiratory viral infections&#xD;
      diagnosed during the first year post SOT and HSCT; 2a) Determine the all-cause mortality&#xD;
      within 3 months of a respiratory viral infection diagnosed during an inpatient admission in&#xD;
      the first year post SOT and HSCT; 2b) Determine the proportion of deaths within 3 months of a&#xD;
      respiratory viral infection diagnosed during an inpatient admission deemed to be directly&#xD;
      attributable to that infection; and 3) To identify factors known at time of onset of the&#xD;
      inpatient respiratory viral infection that are associated with all-cause mortality. The study&#xD;
      cohort will consist of any SOT or HSCT recipient ≤18 years of age that received their&#xD;
      transplant between January 1st, 2010 and June 30th, 2013. Th cohort will determine the&#xD;
      incidence of respiratory viral infections diagnosed during an inpatient admission in the&#xD;
      first year post-transplant. A sub-cohort of patients that develop a respiratory viral&#xD;
      infection within one year of transplantation will be leveraged to investigate factors&#xD;
      associated with mortality in the 3 months after respiratory viral infection. Baseline and&#xD;
      demographic characteristics will be summarized by standard descriptive summaries. Categorical&#xD;
      variables will be summarized by frequencies while continuous variables will be summarized&#xD;
      using mean, standard deviation and/or median, twenty-fifth and seventy-fifth percentiles,&#xD;
      minimum, and maximum. This is a minimal risk study using data that will be collected&#xD;
      retrospectively from medical charts. The only potential risk would be loss of&#xD;
      confidentiality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Incidence of respiratory viral infection</measure>
    <time_frame>1 year post transplant</time_frame>
    <description>Pediatric SOT/HSCT recipients who do not develop respiratory viral infection within 1 year following transplant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality of respiratory viral infection</measure>
    <time_frame>3 months after respiratory viral infection</time_frame>
    <description>Determine the all-cause mortality within 3 months of a respiratory viral infection diagnosed during an inpatient admission in the first year post SOT and HSCT.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Factors associated with all-cause mortality of respiratory viral infection</measure>
    <time_frame>3 months after respiratory viral infection</time_frame>
    <description>This tertiary aim will include just those patients that had an inpatient respiratory viral infection. The analysis will explore the association of factors known at time of onset of the respiratory viral infection with 3 month all-cause mortality</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2669</enrollment>
  <condition>Infection in Solid Organ Transplant Recipients</condition>
  <condition>Complications of Organ Transplant</condition>
  <condition>Respiratory Viral Infection</condition>
  <arm_group>
    <arm_group_label>Cohort Population</arm_group_label>
    <description>Pediatric SOT/HSCT recipients</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study cohort will consist of any SOT or HSCT recipient ≤18 years of age that received&#xD;
        their transplant between January 1st, 2010 and June 30th, 2013. Participants will have&#xD;
        information collected from 30 days prior to transplant until the first of the following:&#xD;
        365 days post receipt of transplant, death, or loss to follow-up. If a patient has more&#xD;
        than one viral respiratory infection of the same pathogen during the study period, then&#xD;
        only the first infection will be considered unless isolated at least one month after the&#xD;
        first positive test and only if after at least two negative tests for that same virus. A&#xD;
        patient can contribute more than one viral respiratory infection if they are caused by&#xD;
        different viral pathogens.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females age 0 to &lt;18 years at the time of HSCT or SOT&#xD;
&#xD;
          -  Transplantation occurred between January 1st, 2010 and June 30th, 2013.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William J Steinbach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>December 14, 2015</last_update_submitted>
  <last_update_submitted_qc>December 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2015</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02260596
org study id: Pro00056727
nct id: NCT02260596
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell transplant
      (HSCT) recipients will be assembled to determine the incidence of respiratory viral
      infections diagnosed during an inpatient admission in the first year post-transplant. A
      sub-cohort of patients that develop a respiratory viral infection within one year of
      transplantation will be leveraged to investigate factors associated with mortality in the
      three months after respiratory viral infection.
The purpose of the study is to 1) Determine the incidence of respiratory viral infections
      diagnosed during the first year post SOT and HSCT; 2a) Determine the all-cause mortality
      within 3 months of a respiratory viral infection diagnosed during an inpatient admission in
      the first year post SOT and HSCT; 2b) Determine the proportion of deaths within 3 months of a
      respiratory viral infection diagnosed during an inpatient admission deemed to be directly
      attributable to that infection; and 3) To identify factors known at time of onset of the
      inpatient respiratory viral infection that are associated with all-cause mortality. The study
      cohort will consist of any SOT or HSCT recipient ≤18 years of age that received their
      transplant between January 1st, 2010 and June 30th, 2013. Th cohort will determine the
      incidence of respiratory viral infections diagnosed during an inpatient admission in the
      first year post-transplant. A sub-cohort of patients that develop a respiratory viral
      infection within one year of transplantation will be leveraged to investigate factors
      associated with mortality in the 3 months after respiratory viral infection. Baseline and
      demographic characteristics will be summarized by standard descriptive summaries. Categorical
      variables will be summarized by frequencies while continuous variables will be summarized
      using mean, standard deviation and/or median, twenty-fifth and seventy-fifth percentiles,
      minimum, and maximum. This is a minimal risk study using data that will be collected
      retrospectively from medical charts. The only potential risk would be loss of
      confidentiality.
observational model: Cohort
time perspective: Retrospective
measure: Incidence of respiratory viral infection
time frame: 1 year post transplant
description: Pediatric SOT/HSCT recipients who do not develop respiratory viral infection within 1 year following transplant
measure: All-cause mortality of respiratory viral infection
time frame: 3 months after respiratory viral infection
description: Determine the all-cause mortality within 3 months of a respiratory viral infection diagnosed during an inpatient admission in the first year post SOT and HSCT.
measure: Factors associated with all-cause mortality of respiratory viral infection
time frame: 3 months after respiratory viral infection
description: This tertiary aim will include just those patients that had an inpatient respiratory viral infection. The analysis will explore the association of factors known at time of onset of the respiratory viral infection with 3 month all-cause mortality
arm group label: Cohort Population
description: Pediatric SOT/HSCT recipients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: William J Steinbach, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases