<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/NCT04412317</url>
  </required_header>
  <id_info>
    <org_study_id>VIGIL</org_study_id>
    <nct_id>NCT04412317</nct_id>
  </id_info>
  <brief_title>Use of PCR-Sars-CoV-2 in Children</brief_title>
  <acronym>VIGIL</acronym>
  <official_title>National Observatory of the Care of Young Sick Children in Community or Not, Indications and Cost-effectiveness of PCR-Sars-CoV-2 - VIGIL Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Intercommunal Creteil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Association Clinique Thérapeutique Infantile du val de Marne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GPIP</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>AFPA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Francophone Pediatric Resuscitation and Emergency Group (GFRUP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Hospitalier Intercommunal Creteil</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>
      The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time&#xD;
      when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical&#xD;
      criteria (even if no clinical picture suggestive of COVID had been clearly identified). The&#xD;
      management of sick young children (with respiratory tract infection that could be attributed&#xD;
      to COVID) by pediatricians (infectious diseases specialists, emergency physicians, general&#xD;
      practitioners, and outpatients) was facilitated by an algorithm whose objective was to help&#xD;
      define the indications for SARS-CoV-2 PCR and subsequently for antigenic testing. The current&#xD;
      technique of deep nasopharyngeal swabbing (for PCR or antigenic testing) is delicate and&#xD;
      difficult in children, and is therefore a serious handicap for community-based screening,&#xD;
      especially since infectious episodes are frequent in children. Since then, nasal self-tests&#xD;
      that can be easily used in children have been commercialized and have facilitated screening.&#xD;
&#xD;
      Because of the similarity between the clinical signs of respiratory tract infections in&#xD;
      children, it is often impossible to distinguish between different viral respiratory&#xD;
      infections and epidemics may overlap in time. However, the identification of the pathogen is&#xD;
      the key to improve management of these infectious diseases. The VIGIL study is therefore&#xD;
      continuing, still facilitated by the existence of an active pediatric network existing for 20&#xD;
      years. ACTIV AFPA and GPIP have created networks of hospital and ambulatory pediatricians who&#xD;
      actively participate in various observatories&#xD;
      https://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatories&#xD;
      have resulted in the publication of more than 80 articles in international journals&#xD;
      (https://www.activ-france.com/fr/publications).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Anticipated">May 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2024</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test</measure>
    <time_frame>At inclusion</time_frame>
    <description>Number of positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test on total number of PCR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of symptomatic children</measure>
    <time_frame>the day of PCR or RAD result</time_frame>
    <description>Number of positive PCR result in the sick child in the presence of a Covid contagion in the family environment or not on total number of PCR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>presence or absence of positive people in close contacts</measure>
    <time_frame>the day of PCR or RAD result</time_frame>
    <description>Number of RAD-Sars-CoV-2 positive in the sick child in the presence of a Covid contagion in the family environment or not on number of negative RAD-Sars-CoV-2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of RAD RSV and Flu positive in children with respiratory tract infection</measure>
    <time_frame>the day of PCR or RAD result</time_frame>
    <description>Number of RAD RSV and Flu positive in children with respiratory tract infection on total number of tests</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of antigen test compared to PCR</measure>
    <time_frame>the day of PCR or RAD result</time_frame>
    <description>Sensibility and specificity of the test</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">12000</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>Children &lt; 15 years old</arm_group_label>
    <description>Patients under 15 years old who consults a physician on an outpatient basis or in the emergency room and who requires a Sars-CoV-2 RT- PCR (nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction) diagnostic</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Child from birth to 14 years of age consulting their doctor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children under 15 years of age&#xD;
&#xD;
          -  Prescription of a PCR-Sars-CoV-2&#xD;
&#xD;
          -  VIGIL information note given to parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate by the patient, family member or legal representative&#xD;
             (depending on the situation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Corinne Levy, MD</last_name>
    <phone>148850404</phone>
    <phone_ext>33</phone_ext>
    <email>corinne.levy@activ-france.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>ACTIV network</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corinne LEVY, MD</last_name>
      <phone>148850404</phone>
      <phone_ext>33</phone_ext>
      <email>corinne.levy@activ-france.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>PARI network</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corinne Levy, MD</last_name>
      <email>corinne.levy@activ-france.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/36116761/</url>
    <description>From the original SARS-CoV-2 strain to the Omicron variant: Predictors of COVID-19 in ambulatory symptomatic children</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/36210936/</url>
    <description>Diagnostic accuracy of SARS-CoV-2 rapid antigen test from self-collected anterior nasal swabs in children compared to rapid antigen test and RT-PCR from nasopharyngeal swabs collected by healthcare workers: A multicentric prospective study</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/34271254/</url>
    <description>Assessment of SARS-CoV-2 testing in children during a low prevalence period (VIGIL study 1)</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 30, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04412317
org study id: VIGIL
nct id: NCT04412317
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The VIGIL study was set up at the beginning of the pandemic, in the spring of 2020, at a time
      when diagnostic testing for SARS-CoV-2 had to be performed according to specific clinical
      criteria (even if no clinical picture suggestive of COVID had been clearly identified). The
      management of sick young children (with respiratory tract infection that could be attributed
      to COVID) by pediatricians (infectious diseases specialists, emergency physicians, general
      practitioners, and outpatients) was facilitated by an algorithm whose objective was to help
      define the indications for SARS-CoV-2 PCR and subsequently for antigenic testing. The current
      technique of deep nasopharyngeal swabbing (for PCR or antigenic testing) is delicate and
      difficult in children, and is therefore a serious handicap for community-based screening,
      especially since infectious episodes are frequent in children. Since then, nasal self-tests
      that can be easily used in children have been commercialized and have facilitated screening.

      Because of the similarity between the clinical signs of respiratory tract infections in
      children, it is often impossible to distinguish between different viral respiratory
      infections and epidemics may overlap in time. However, the identification of the pathogen is
      the key to improve management of these infectious diseases. The VIGIL study is therefore
      continuing, still facilitated by the existence of an active pediatric network existing for 20
      years. ACTIV AFPA and GPIP have created networks of hospital and ambulatory pediatricians who
      actively participate in various observatories
      https://www.jpeds.com/article/S0022-3476(17)31606-2/fulltext To date, these observatories
      have resulted in the publication of more than 80 articles in international journals
      (https://www.activ-france.com/fr/publications).
observational model: Cohort
time perspective: Prospective
measure: Percentage of children screened with a positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test
time frame: At inclusion
description: Number of positive PCR result or a positive Rapid Antigenic Diagnostic (RAD) test on total number of PCR
measure: Number of symptomatic children
time frame: the day of PCR or RAD result
description: Number of positive PCR result in the sick child in the presence of a Covid contagion in the family environment or not on total number of PCR
measure: presence or absence of positive people in close contacts
time frame: the day of PCR or RAD result
description: Number of RAD-Sars-CoV-2 positive in the sick child in the presence of a Covid contagion in the family environment or not on number of negative RAD-Sars-CoV-2
measure: Percentage of RAD RSV and Flu positive in children with respiratory tract infection
time frame: the day of PCR or RAD result
description: Number of RAD RSV and Flu positive in children with respiratory tract infection on total number of tests
measure: Accuracy of antigen test compared to PCR
time frame: the day of PCR or RAD result
description: Sensibility and specificity of the test
arm group label: Children < 15 years old
description: Patients under 15 years old who consults a physician on an outpatient basis or in the emergency room and who requires a Sars-CoV-2 RT- PCR (nucleic acid using real-time reverse-transcriptase polymerase-chain-reaction) diagnostic
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 14 Years
healthy volunteers: No
last name: Corinne Levy, MD
phone: 148850404
phone ext: 33
email: corinne.levy@activ-france.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
url: https://pubmed.ncbi.nlm.nih.gov/36116761/
description: From the original SARS-CoV-2 strain to the Omicron variant: Predictors of COVID-19 in ambulatory symptomatic children
url: https://pubmed.ncbi.nlm.nih.gov/36210936/
description: Diagnostic accuracy of SARS-CoV-2 rapid antigen test from self-collected anterior nasal swabs in children compared to rapid antigen test and RT-PCR from nasopharyngeal swabs collected by healthcare workers: A multicentric prospective study
url: https://pubmed.ncbi.nlm.nih.gov/34271254/
description: Assessment of SARS-CoV-2 testing in children during a low prevalence period (VIGIL study 1)
responsible party type: Sponsor