<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/NCT02186522</url>
  </required_header>
  <id_info>
    <org_study_id>2014/0208</org_study_id>
    <nct_id>NCT02186522</nct_id>
  </id_info>
  <brief_title>Immune Failure in Critical Therapy (INFECT) Study</brief_title>
  <acronym>INFECT</acronym>
  <official_title>Immune Failure in Critical Therapy(INFECT) Study: Phenotyping Immune Cell Dysfunction to Predict Outcomes in Critically Ill Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Technology Strategy Board, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Becton, Dickinson and Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients admitted to intensive care units (ICU) are at high risk of developing secondary&#xD;
      infections, and this is in part due to dysfunction or failure of their 'germ killing'&#xD;
      functions (the immune system). Our group has recently identified three signatures of immune&#xD;
      system failure which can be readily detected on a blood sample, and importantly, appear to&#xD;
      predict the chances of developing secondary infection. Such a test would have major benefits&#xD;
      for the management of patients in intensive care if it can be translated into a test usable&#xD;
      in everyday clinical practice. This study aims to validate our original findings in a cohort&#xD;
      of patients from multiple ICUs, using a test which will be suitable for everyday clinical&#xD;
      practice, and thus take the next step towards developing a market-ready test.&#xD;
&#xD;
      Study hypothesis:&#xD;
&#xD;
      Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict&#xD;
      the risk of nosocomial infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The development of immune dysfunction (see below) and its association with ICU-acquired infection within the 16 day study period.</measure>
    <time_frame>Within the first 16 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU Outcome (lived/died)</measure>
    <time_frame>Within first 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from sepsis</measure>
    <time_frame>Within first 16 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ dysfunction as determined by SOFA score</measure>
    <time_frame>Within first 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>Up to 3 months (for current hospital admission only)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of organ support in ICU</measure>
    <time_frame>Within first 14 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">168</enrollment>
  <condition>Sepsis</condition>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Critical Care Patients</arm_group_label>
    <description>Patients staying in the ICU for at least 48 hours, requiring external support of one or more organs (invasive ventilation, inotropes/vasopressors or renal replacement therapy) and who are not expected to die within 48 hours of study entry.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Samples of serum and plasma stored frozen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Critical Care patients who are expected to remain in ICU for at least 48 hours, and require&#xD;
        the external support of one or more organs (invasive ventilation, inotropes/vasopressors or&#xD;
        renal replacement therapy) and who are not expected to die within 48 hours of study entry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;16 (&gt;18 in England)&#xD;
&#xD;
          -  Requiring level 3 care (i.e. requiring invasive support of respiratory system alone,&#xD;
             or two or more other organ systems (haemofiltration, inotropes/vasopressors)&#xD;
&#xD;
          -  Predicted to remain in ICU for at least 48 hours,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not expected to survive for a further 24 hours&#xD;
&#xD;
          -  Known or suspected ICU-acquired infection at time of screening (non-ICU acquired&#xD;
             nosocomial infection - i.e. non-ICU healthcare associated infection is NOT and&#xD;
             exclusion)&#xD;
&#xD;
          -  Known inborn errors of immune function&#xD;
&#xD;
          -  Immunosuppression (corticosteroids up to 400mg hydrocortisone equivalent daily dose&#xD;
             permitted)&#xD;
&#xD;
          -  HIV infection&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Previously enrolled in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Conway Morris, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cambridge</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tim S Walsh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Lothian/University of Edinburgh</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Simpson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Newcastle University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alistair Roy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City Hospitals Sunderland NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alun Brown</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Manu Shankar-Hari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guy's and St Thomas' NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anthony Bateman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Lothian (Western General Hospital)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Infirmary of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunderland Royal Hospital</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>Septic shock</keyword>
  <keyword>Critical care</keyword>
  <keyword>Immune dysfunction</keyword>
  <keyword>Inflammatory markers</keyword>
  <keyword>Neutrophil</keyword>
  <keyword>Monocyte</keyword>
  <keyword>Tregs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</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/NCT02186522
org study id: 2014/0208
nct id: NCT02186522
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Patients admitted to intensive care units (ICU) are at high risk of developing secondary
      infections, and this is in part due to dysfunction or failure of their 'germ killing'
      functions (the immune system). Our group has recently identified three signatures of immune
      system failure which can be readily detected on a blood sample, and importantly, appear to
      predict the chances of developing secondary infection. Such a test would have major benefits
      for the management of patients in intensive care if it can be translated into a test usable
      in everyday clinical practice. This study aims to validate our original findings in a cohort
      of patients from multiple ICUs, using a test which will be suitable for everyday clinical
      practice, and thus take the next step towards developing a market-ready test.

      Study hypothesis:

      Measurement of neutrophil CD88, monocyte HLA-DR and percentage Tregs will accurately predict
      the risk of nosocomial infection.
observational model: Cohort
time perspective: Prospective
measure: The development of immune dysfunction (see below) and its association with ICU-acquired infection within the 16 day study period.
time frame: Within the first 16 days
measure: ICU Outcome (lived/died)
time frame: Within first 16 days
measure: Death from sepsis
time frame: Within first 16 days
measure: Organ dysfunction as determined by SOFA score
time frame: Within first 14 days
measure: Length of ICU stay
time frame: Up to 3 months (for current hospital admission only)
measure: Duration of organ support in ICU
time frame: Within first 14 days
arm group label: Critical Care Patients
description: Patients staying in the ICU for at least 48 hours, requiring external support of one or more organs (invasive ventilation, inotropes/vasopressors or renal replacement therapy) and who are not expected to die within 48 hours of study entry.
Samples of serum and plasma stored frozen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Conway Morris, MD
role: Principal Investigator
affiliation: University of Cambridge
last name: Tim S Walsh, MD
role: Principal Investigator
affiliation: NHS Lothian/University of Edinburgh
last name: John Simpson, MD
role: Principal Investigator
affiliation: Newcastle University
last name: Alistair Roy, MD
role: Principal Investigator
affiliation: City Hospitals Sunderland NHS Foundation Trust
last name: Alun Brown
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
last name: Manu Shankar-Hari, MD
role: Principal Investigator
affiliation: Guy's and St Thomas' NHS Foundation Trust
last name: Anthony Bateman, MD
role: Principal Investigator
affiliation: NHS Lothian (Western General Hospital)
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Shock, Septic