<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/NCT04471493</url>
  </required_header>
  <id_info>
    <org_study_id>ACT0116</org_study_id>
    <nct_id>NCT04471493</nct_id>
  </id_info>
  <brief_title>Pediatric and Ambulatory Research in Infectious Diseases</brief_title>
  <acronym>PARI</acronym>
  <official_title>Real Time Surveillance of Pediatric Infectious Diseases in French Ambulatory Care: PARI Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association Clinique Thérapeutique Infantile du val de Marne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AFPA (Association Française de Pédiatrie Ambulatoire)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Association Clinique Thérapeutique Infantile du val de Marne</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Many ambulatory networks are mainly based on diagnoses made by first-line physicians not&#xD;
      specifically trained to join the network. Here we aim to set up a surveillance network on&#xD;
      pediatric infectious diseases with an investment in teaching with specific trainings of&#xD;
      participating pediatricians, increasing in use of point of care tests, and automated data&#xD;
      extraction from the computers of the pediatricians.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      107 pediatricians among the 1400 members of the French ambulatory pediatric association, AFPA&#xD;
      (Association Française de Pédiatrie Ambulatoire) were involved in this survey.To belong to&#xD;
      the PARI network, pediatricians have to use the same software, Axi5-Infansoft (developed by&#xD;
      CompuGroup Medical, Nanterre, France) for electronic medical record of children. The&#xD;
      pediatricians were trained to the use of point of care tests and to the infectious diagnoses&#xD;
      (otitis, pharyngitis, varicella, bronchiolitis, influenza, pneumonia, etc..). The study&#xD;
      population consisted of all children under 16 years of age from the patient population for&#xD;
      which an infectious disease was diagnosed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Anticipated">August 2, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 27, 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>5 Years</target_duration>
  <primary_outcome>
    <measure>Evaluation of the number of infectious diseases</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the use of point of care tests</measure>
    <time_frame>5 years</time_frame>
    <description>Proportion of use of point of care tests and positivity rate according to the infectious diseases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the antibiotic treatments</measure>
    <time_frame>5 years</time_frame>
    <description>Proportion of each antibiotic treatments according to the infectious diseases</description>
  </secondary_outcome>
  <enrollment type="Anticipated">400000</enrollment>
  <condition>Otitis</condition>
  <condition>Bronchiolitis</condition>
  <condition>Influenza</condition>
  <condition>Pharyngitis</condition>
  <condition>Varicella</condition>
  <condition>Pneumonia</condition>
  <condition>Gastroenteritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children under 16 years with infectious disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children under 16 years of age with at least one infectious disease among:&#xD;
&#xD;
          -  pharyngitis&#xD;
&#xD;
          -  otitis&#xD;
&#xD;
          -  pneumonia&#xD;
&#xD;
          -  influenza&#xD;
&#xD;
          -  bronchiolitisz&#xD;
&#xD;
          -  varicella&#xD;
&#xD;
          -  gastroenteritis&#xD;
&#xD;
          -  enterovirus disease&#xD;
&#xD;
          -  bordetella pertussis disease&#xD;
&#xD;
          -  using the same same software, Axi5-Infansoft (developed by CompuGroup Medical,&#xD;
             Nanterre, France)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parental refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Corinne LEVY, MD</last_name>
    <phone>0033148850404</phone>
    <email>corinne.levy@activ-france.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stéphane Béchet, MSc</last_name>
    <phone>0033148850404</phone>
    <email>stephane.bechet@activ-france.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AFPA</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Corinne Levy, MD</last_name>
      <phone>0033148850404</phone>
      <email>corinne.levy@activ-france.fr</email>
    </contact>
    <contact_backup>
      <last_name>Stéphane Béchet, MSc</last_name>
      <phone>0033148850404</phone>
      <email>stephane.bechet@activ-france.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/33657594/</url>
    <description>New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital Era</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/36034052/</url>
    <description>Trends in pediatric ambulatory community acquired infections before and during COVID-19 pandemic: A prospective multicentric surveillance study in France</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vaccination</keyword>
  <keyword>Antibiotic treatment</keyword>
  <keyword>Point of care test</keyword>
  <keyword>automated data extraction</keyword>
  <keyword>network</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Pharyngitis</mesh_term>
    <mesh_term>Gastroenteritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04471493
org study id: ACT0116
nct id: NCT04471493
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Many ambulatory networks are mainly based on diagnoses made by first-line physicians not
      specifically trained to join the network. Here we aim to set up a surveillance network on
      pediatric infectious diseases with an investment in teaching with specific trainings of
      participating pediatricians, increasing in use of point of care tests, and automated data
      extraction from the computers of the pediatricians.
107 pediatricians among the 1400 members of the French ambulatory pediatric association, AFPA
      (Association Française de Pédiatrie Ambulatoire) were involved in this survey.To belong to
      the PARI network, pediatricians have to use the same software, Axi5-Infansoft (developed by
      CompuGroup Medical, Nanterre, France) for electronic medical record of children. The
      pediatricians were trained to the use of point of care tests and to the infectious diagnoses
      (otitis, pharyngitis, varicella, bronchiolitis, influenza, pneumonia, etc..). The study
      population consisted of all children under 16 years of age from the patient population for
      which an infectious disease was diagnosed.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of the number of infectious diseases
time frame: 5 years
measure: Evaluation of the use of point of care tests
time frame: 5 years
description: Proportion of use of point of care tests and positivity rate according to the infectious diseases
measure: Evaluation of the antibiotic treatments
time frame: 5 years
description: Proportion of each antibiotic treatments according to the infectious diseases
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 16 Years
last name: Corinne LEVY, MD
phone: 0033148850404
email: corinne.levy@activ-france.fr
last name: Stéphane Béchet, MSc
phone: 0033148850404
email: stephane.bechet@activ-france.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
url: https://pubmed.ncbi.nlm.nih.gov/33657594/
description: New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital Era
url: https://pubmed.ncbi.nlm.nih.gov/36034052/
description: Trends in pediatric ambulatory community acquired infections before and during COVID-19 pandemic: A prospective multicentric surveillance study in France
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Bronchiolitis
mesh term: Pharyngitis
mesh term: Gastroenteritis
sharing ipd: Undecided