<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/NCT03757429</url>
  </required_header>
  <id_info>
    <org_study_id>2017-515IMAR</org_study_id>
    <nct_id>NCT03757429</nct_id>
  </id_info>
  <brief_title>Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus</brief_title>
  <acronym>IMAR</acronym>
  <official_title>Inflammatory Mediators Associated With Infection by Respiratory Syncytial Virus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swedish University of Agricultural Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Uppsala University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infection with human respiratory syncytial (RS) virus is the most common cause of hospital&#xD;
      stay due to pediatric lower respiratory tract infection. An exaggerated immune response&#xD;
      contributes to the pathogenesis and small children may have over reactive airways for a long&#xD;
      time after an infection.&#xD;
&#xD;
      New research has shown that polymorphonuclear leukocytes (PMNs) are stimulated by the virus.&#xD;
      Besides fighting the infection they also cause collateral damage to the host. Among other&#xD;
      mechanisms PMNs stimulates mucus formation that affects breathing. They also secrete enzymes,&#xD;
      toxic proteins and free radicals that may cause harm to lung tissue and airways.&#xD;
&#xD;
      The current project strives towards identifying and quantifying inflammatory mediators in&#xD;
      sputum, urine and blood of children with severe RS-virus infection. The ultimate aim of the&#xD;
      project is to, in detail, describe proteins contributing to the pathogenesis of the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</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>Levels of inflammatory mediators in sputum</measure>
    <time_frame>Up to three weeks</time_frame>
    <description>Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of inflammatory mediators in blood</measure>
    <time_frame>Up to three weeks</time_frame>
    <description>Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Levels of inflammatory mediators in urine</measure>
    <time_frame>Up to three weeks</time_frame>
    <description>Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease severity as measured by sequential organ failure assessment score (SOFA-score)</measure>
    <time_frame>Up to 30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function as measured in respirator</measure>
    <time_frame>Up to 30-days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function as measured by spirometry</measure>
    <time_frame>Within 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lung function as measured by spirometry</measure>
    <time_frame>Within 10 years</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">31</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <condition>Respiratory Syncytial Virus Infections</condition>
  <arm_group>
    <arm_group_label>RS-virus infection with mechanical ventilation</arm_group_label>
    <description>Patients admitted to the pediatric ICU with verified or suspected RS-virus infection that are mechanically ventilated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-RS-virus infection with mechanical ventilation</arm_group_label>
    <description>Patients admitted to the pediatric ICU due to a cause other than a verified or suspected respiratory tract infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RS-virus infection</intervention_name>
    <description>The intervention consists of lower respiratory tract infection due to RS-virus</description>
    <arm_group_label>Non-RS-virus infection with mechanical ventilation</arm_group_label>
    <arm_group_label>RS-virus infection with mechanical ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children admitted to pediatric ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission to pediatric intensive care unit&#xD;
&#xD;
          -  Clinical need for invasive ventilation&#xD;
&#xD;
          -  Clinical need for intravascular catheterization&#xD;
&#xD;
          -  Clinical need for urine bladder catheterization&#xD;
&#xD;
          -  Patients with verified or suspected RS-virus-infection or no respiratory tract&#xD;
             infection (control group)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Chronic inflammatory lung disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Akademiska sjukhuset, Centraloperation</name>
      <address>
        <city>Uppsala</city>
        <zip>75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>May 26, 2022</last_update_submitted>
  <last_update_submitted_qc>May 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uppsala University</investigator_affiliation>
    <investigator_full_name>Robert Frithiof</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>Respiratory Tract Infections</mesh_term>
    <mesh_term>Respiratory Syncytial Virus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03757429
org study id: 2017-515IMAR
nct id: NCT03757429
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Infection with human respiratory syncytial (RS) virus is the most common cause of hospital
      stay due to pediatric lower respiratory tract infection. An exaggerated immune response
      contributes to the pathogenesis and small children may have over reactive airways for a long
      time after an infection.

      New research has shown that polymorphonuclear leukocytes (PMNs) are stimulated by the virus.
      Besides fighting the infection they also cause collateral damage to the host. Among other
      mechanisms PMNs stimulates mucus formation that affects breathing. They also secrete enzymes,
      toxic proteins and free radicals that may cause harm to lung tissue and airways.

      The current project strives towards identifying and quantifying inflammatory mediators in
      sputum, urine and blood of children with severe RS-virus infection. The ultimate aim of the
      project is to, in detail, describe proteins contributing to the pathogenesis of the disease.
observational model: Cohort
time perspective: Prospective
measure: Levels of inflammatory mediators in sputum
time frame: Up to three weeks
description: Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
measure: Levels of inflammatory mediators in blood
time frame: Up to three weeks
description: Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
measure: Levels of inflammatory mediators in urine
time frame: Up to three weeks
description: Simultaneous detection and quantification of hundreds of potential mediators using mass-spectrometry
measure: Disease severity as measured by sequential organ failure assessment score (SOFA-score)
time frame: Up to 30-days
measure: Lung function as measured in respirator
time frame: Up to 30-days
measure: Lung function as measured by spirometry
time frame: Within 1 year
measure: Lung function as measured by spirometry
time frame: Within 10 years
arm group label: RS-virus infection with mechanical ventilation
description: Patients admitted to the pediatric ICU with verified or suspected RS-virus infection that are mechanically ventilated.
arm group label: Non-RS-virus infection with mechanical ventilation
description: Patients admitted to the pediatric ICU due to a cause other than a verified or suspected respiratory tract infection.
intervention type: Other
intervention name: RS-virus infection
description: The intervention consists of lower respiratory tract infection due to RS-virus
arm group label: Non-RS-virus infection with mechanical ventilation
arm group label: RS-virus infection with mechanical ventilation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Uppsala University
investigator full name: Robert Frithiof
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
mesh term: Respiratory Syncytial Virus Infections
sharing ipd: No