xml: <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/NCT06017310</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0697</org_study_id>
      <nct_id>NCT06017310</nct_id>
    </id_info>
    <brief_title>Respiferon Project</brief_title>
    <acronym>Respiferon</acronym>
    <official_title>Evaluation of the Type 1 IFN Response in Viral Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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>
        Respiratory viral infections (RVIs) represent a major public health problem and a great&#xD;
        burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the&#xD;
        source of an infection, microbiology laboratories routinely perform a crucial step: the&#xD;
        search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety&#xD;
        of pathogens, testing for the existence of all potential viruses, bacteria, or fungi&#xD;
        accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the&#xD;
        rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic,&#xD;
        underscores the urgency of promptly developing new innovative diagnostic tests.&#xD;
  &#xD;
        To address these needs, researchers have dedicated several years to developing indirect&#xD;
        methodologies notably centered around utilizing markers derived from the host's immune&#xD;
        system. Among these, one particularly promising approach focuses on measuring the expression&#xD;
        of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby&#xD;
        facilitating viral diagnosis. This methodology's efficacy has been proven in the context of&#xD;
        SARS-CoV-2 infections.&#xD;
  &#xD;
        This study's objective is to assess the functionality of such a tool across a spectrum of&#xD;
        Respiratory Viral Infections (RVIs) prevalent within a French population during the winter&#xD;
        season.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 11, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</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>Presence or Absence of a replicative virus detected by viral culture</measure>
      <time_frame>One sample at inclusion</time_frame>
      <description>RT-qPCR/qPCR-positive NPS will be inoculated on suitable cell lines using a culture medium appropriate for growth. Plates will be incubated at 33°C in 5% CO2 for 96 hours. Positive samples will be harvested for the confirmation technique, while negative samples will be cultured for 8 days. RNA or DNA from infected cells will be harvested and will be assayed with Panther Fusion® RT-PCR/PCR kits (Hologic Inc., San Diego, CA, USA) for viral identification, except for RSV and influenza A and B viruses (IAV/IBV) which were detected by immunofluorescence using Thermo ScientificTM IMAGENTM kits (Thermo Fischer Scientific, Waltham, MA, USA).</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Respiratory Viral Infection</condition>
    <arm_group>
      <arm_group_label>Replicative viruses</arm_group_label>
      <description>Presence of a replicative virus determined by viral culture</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Unreplicative viruses</arm_group_label>
      <description>Absence of a replicative virus determined by viral culture</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Evaluate the performance of IFN I/III</intervention_name>
      <description>Evaluate the response in diagnosing non-respiratory viral infection.</description>
      <arm_group_label>Replicative viruses</arm_group_label>
      <arm_group_label>Unreplicative viruses</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients hospitalized at the Hospices Civils de Lyon (HCL) with respiratory infection&#xD;
          symptoms.&#xD;
  &#xD;
          Nasopharyngeal samples positive for the detection of a respiratory virus for which the&#xD;
          viral culture has been carried out will be selected by the CRB. After informing the&#xD;
          patients of the study, the IFN I/III response can be assessed on these same nasopharyngeal&#xD;
          samples (no additional sample necessary).&#xD;
  &#xD;
          The data thus obtained will allow to determine the capacity of the IFN I/III response to&#xD;
          detect replicating viruses.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Positive nasopharyngeal samples for the detection of a virus, for which the&#xD;
               replicative character has been established by the viral culture technique (500µL&#xD;
               minimum required)&#xD;
  &#xD;
            -  Samples kept at the CRB since 2018&#xD;
  &#xD;
            -  Information to patients carried out and non-objection collected-&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  N/A&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Infective Agents Institute, Croix rousse Hospital</name>
        <address>
          <city>Lyon</city>
          <state>Rhone</state>
          <zip>69004</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sophie Trouillet-Assant, PhD</last_name>
        <phone>04 72 67 87 80</phone>
        <email>Sophie.trouillet-assant@chu-lyon.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>respiratory viruses</keyword>
    <keyword>Nasal IFN-1 Score</keyword>
    <keyword>Nasopharyngeal Swab</keyword>
    <keyword>Replicative virus</keyword>
    <keyword>Infectiousness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Virus Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017310
  org study id: 69HCL23_0697
  nct id: NCT06017310
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Respiratory viral infections (RVIs) represent a major public health problem and a great
        burden in terms of morbidity and mortality in children and adults worldwide. To ascertain the
        source of an infection, microbiology laboratories routinely perform a crucial step: the
        search for the pathogen through Polymerase Chain Reaction (PCR). Due to the extensive variety
        of pathogens, testing for the existence of all potential viruses, bacteria, or fungi
        accountable for the infection is an impractical and time-intensive endeavor. Furthermore, the
        rise of novel pathogens, exemplified by those accountable for the recent SARS-CoV-2 pandemic,
        underscores the urgency of promptly developing new innovative diagnostic tests.
  
        To address these needs, researchers have dedicated several years to developing indirect
        methodologies notably centered around utilizing markers derived from the host's immune
        system. Among these, one particularly promising approach focuses on measuring the expression
        of interferon-stimulated genes, which are uniquely triggered by viral infections, thereby
        facilitating viral diagnosis. This methodology's efficacy has been proven in the context of
        SARS-CoV-2 infections.
  
        This study's objective is to assess the functionality of such a tool across a spectrum of
        Respiratory Viral Infections (RVIs) prevalent within a French population during the winter
        season.
  observational model: Cohort
  time perspective: Retrospective
  measure: Presence or Absence of a replicative virus detected by viral culture
  time frame: One sample at inclusion
  description: RT-qPCR/qPCR-positive NPS will be inoculated on suitable cell lines using a culture medium appropriate for growth. Plates will be incubated at 33°C in 5% CO2 for 96 hours. Positive samples will be harvested for the confirmation technique, while negative samples will be cultured for 8 days. RNA or DNA from infected cells will be harvested and will be assayed with Panther Fusion® RT-PCR/PCR kits (Hologic Inc., San Diego, CA, USA) for viral identification, except for RSV and influenza A and B viruses (IAV/IBV) which were detected by immunofluorescence using Thermo ScientificTM IMAGENTM kits (Thermo Fischer Scientific, Waltham, MA, USA).
  arm group label: Replicative viruses
  description: Presence of a replicative virus determined by viral culture
  arm group label: Unreplicative viruses
  description: Absence of a replicative virus determined by viral culture
  intervention type: Diagnostic Test
  intervention name: Evaluate the performance of IFN I/III
  description: Evaluate the response in diagnosing non-respiratory viral infection.
  arm group label: Replicative viruses
  arm group label: Unreplicative viruses
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Virus Diseases