<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/NCT02984046</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0294</org_study_id>
    <secondary_id>2015-A01587-42</secondary_id>
    <nct_id>NCT02984046</nct_id>
  </id_info>
  <brief_title>Acute Bronchiolitis and Severity Markers: Interest in Protein CC16</brief_title>
  <acronym>CC16</acronym>
  <official_title>Acute Bronchiolitis and Severity Markers: Interest in Protein CC16</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <brief_summary>
    <textblock>
      Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.&#xD;
&#xD;
      Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of&#xD;
      epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7&#xD;
      months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and&#xD;
      secondarily for the development of asthma.&#xD;
&#xD;
      Two other markers of airway aggression seem to increase during acute bronchiolitis: serum&#xD;
      SP-D protein and serum soluble receptor sRAGE.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, monocentric, case-control and study Primary end-point: correlation between serum&#xD;
      CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system&#xD;
      established at the time of the admission in Paediatric Emergency Unit. Secondary end-points:&#xD;
      correlation with urinary CC16; correlation with risk factors for bronchial epithelial&#xD;
      aggression, viruses, immediate morbidity and mortality. Study of serum SP-D and sRAGE levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum CC16 rate</measure>
    <time_frame>at day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary CC16 rate</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SP-D rates</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sRAGE rates</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Acute Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>acute bronchiolitis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Protein CC16</intervention_name>
    <arm_group_label>acute bronchiolitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants under 1 year old hospitalized for acute bronchiolitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Broncho dysplasia&#xD;
&#xD;
          -  Preterm under 34 weeks&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  Immune deficiency&#xD;
&#xD;
          -  Suspicion of primary ciliary dyskinesia&#xD;
&#xD;
          -  Congenital heart disease&#xD;
&#xD;
          -  Acute renal failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>André LABBE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick LACARIN</last_name>
    <phone>0473751195</phone>
    <email>placarin@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick LACARIN</last_name>
      <phone>0473751195</phone>
      <email>placarin@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>André LABBE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute bronchiolitis</keyword>
  <keyword>RSV</keyword>
  <keyword>CC16</keyword>
  <keyword>SP-D</keyword>
  <keyword>sRAGE</keyword>
  <keyword>Severity</keyword>
  <keyword>Biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</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/NCT02984046
org study id: CHU-0294
secondary id: 2015-A01587-42
nct id: NCT02984046
lead sponsor: 
Acute bronchiolitis is a common viral infection in infants mainly due to RSV and rhinovirus.

      Biomarkers can be useful for predicting its severity. The serum CC16 is a marker of
      epithelial aggression. Its rate increase during RSV bronchiolitis in infants less than 7
      months. It could be an early predictive biomarker of the severity of acute bronchiolitis, and
      secondarily for the development of asthma.

      Two other markers of airway aggression seem to increase during acute bronchiolitis: serum
      SP-D protein and serum soluble receptor sRAGE.
Prospective, monocentric, case-control and study Primary end-point: correlation between serum
      CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system
      established at the time of the admission in Paediatric Emergency Unit. Secondary end-points:
      correlation with urinary CC16; correlation with risk factors for bronchial epithelial
      aggression, viruses, immediate morbidity and mortality. Study of serum SP-D and sRAGE levels.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Serum CC16 rate
time frame: at day 1
measure: Urinary CC16 rate
time frame: at day 1
measure: SP-D rates
time frame: at day 1
measure: sRAGE rates
time frame: at day 1
arm group label: acute bronchiolitis
arm group type: Experimental
description: Prospective, monocentric, case-control and study Primary end-point: correlation between serum CC16 level and severity of the bronchiolitis, evaluated by a clinical scoring system
intervention type: Drug
intervention name: Protein CC16
arm group label: acute bronchiolitis
criteria: 
gender: All
minimum age: 1 Day
maximum age: 1 Year
healthy volunteers: Accepts Healthy Volunteers
last name: André LABBE
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Patrick LACARIN
phone: 0473751195
email: placarin@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Bronchiolitis