<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/NCT03237299</url>
  </required_header>
  <id_info>
    <org_study_id>NI14034J</org_study_id>
    <nct_id>NCT03237299</nct_id>
  </id_info>
  <brief_title>Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study</brief_title>
  <acronym>CAPE</acronym>
  <official_title>Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      To study the association between several exposures of interest and the occurrence of&#xD;
      infectious loco-regional complications of pharyngitis in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will include in the study (after agreement of child and parents):&#xD;
&#xD;
        -  Cases: children &lt; 18 years old hospitalized for peripharyngeal suppurations, diffuse&#xD;
           cervical cellulitis or cervical adenophlegmon in participating Ear, Nose &amp; Throat (ENT)&#xD;
           and pediatric departments.&#xD;
&#xD;
        -  Controls: children &lt; 18 years old with pharyngitis but without infectious complications&#xD;
           recruited by general practitioners (GPs) or by primary care pediatricians in private&#xD;
           setting, matched to cases by age, date of infectious complication (index date), delay&#xD;
           between the pharyngitis and the index date and, if possible, the referring physician.&#xD;
&#xD;
      Primary endpoint: Difference in the frequency of exposure to various factors among cases and&#xD;
      controls during an exposure window going from the date of diagnosis of pharyngitis to day&#xD;
      -0.5 of the index date of the complication.&#xD;
&#xD;
      Several exposure of interest will be compared between cases and controls. One specific main&#xD;
      exposure of interest during a predefined window of exposure has been defined but will not be&#xD;
      revealed to investigators to avoid selection bias. Several secondary exposure of interest&#xD;
      were a priori defined but will not be revealed to investigators to avoid selection bias.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2019</start_date>
  <completion_date type="Actual">June 3, 2021</completion_date>
  <primary_completion_date type="Actual">June 3, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of exposure of interest</measure>
    <time_frame>from the date of diagnosis of pharyngitis up to 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Magnitude of the exposure of interest</measure>
    <time_frame>from the date of diagnosis of pharyngitis up to 6 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">289</enrollment>
  <condition>Pharyngitis</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Cases: children with loco-regional complications of pharyngitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Controls: children with pharyngitis but without infectious complications</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Collection of data</intervention_name>
    <description>Collection of data on clinical, bacteriological and computed tomography data concerning the case, which will be needed by the adjudication committee and for defining the index date.</description>
    <arm_group_label>Cases</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No collection of data</intervention_name>
    <description>The interviewer will note sociodemographic characteristics (age, weight, sex), symptoms and their evolution, and all drug intakes of the patient during the month before the index date.</description>
    <arm_group_label>Controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cases: participating Ear, Nose &amp; Throat (ENT) and pediatric departments Controls: recruited&#xD;
        ''in office settings'' by general practitioners (GPs) or by primary care paediatricians&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cases: children &lt; 18 years old hospitalized for peripharyngeal suppurations, diffuse&#xD;
        cervical cellulitis or cervical adenophlegmon in participating Ear, Nose &amp; Throat (ENT) and&#xD;
        pediatric departments.&#xD;
&#xD;
        Controls: children &lt; 18 years old with pharyngitis but without infectious complications&#xD;
        recruited by general practitioners (GPs) or by primary care pediatricians in private&#xD;
        setting, matched to cases by age, date of infectious complication (index date), delay&#xD;
        between the pharyngitis and the index date and, if possible, the referring physician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children (cases or controls) with chronic renal failure, hemophilia, chronic&#xD;
        thrombocytopenia or immunosuppression (constitutional or iatrogenic) at the time of&#xD;
        pharyngitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin CHALUMEAU, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Necker Enfants Malades - AP-HP</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharyngitis</keyword>
  <keyword>case-control study</keyword>
  <keyword>loco-regional complications of pharyngitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</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/NCT03237299
org study id: NI14034J
nct id: NCT03237299
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study the association between several exposures of interest and the occurrence of
      infectious loco-regional complications of pharyngitis in children.
Investigators will include in the study (after agreement of child and parents):

        -  Cases: children < 18 years old hospitalized for peripharyngeal suppurations, diffuse
           cervical cellulitis or cervical adenophlegmon in participating Ear, Nose & Throat (ENT)
           and pediatric departments.

        -  Controls: children < 18 years old with pharyngitis but without infectious complications
           recruited by general practitioners (GPs) or by primary care pediatricians in private
           setting, matched to cases by age, date of infectious complication (index date), delay
           between the pharyngitis and the index date and, if possible, the referring physician.

      Primary endpoint: Difference in the frequency of exposure to various factors among cases and
      controls during an exposure window going from the date of diagnosis of pharyngitis to day
      -0.5 of the index date of the complication.

      Several exposure of interest will be compared between cases and controls. One specific main
      exposure of interest during a predefined window of exposure has been defined but will not be
      revealed to investigators to avoid selection bias. Several secondary exposure of interest
      were a priori defined but will not be revealed to investigators to avoid selection bias.
observational model: Case-Control
time perspective: Prospective
measure: Frequency of exposure of interest
time frame: from the date of diagnosis of pharyngitis up to 6 weeks
measure: Magnitude of the exposure of interest
time frame: from the date of diagnosis of pharyngitis up to 6 weeks
arm group label: Cases
description: Cases: children with loco-regional complications of pharyngitis
arm group label: Controls
description: Controls: children with pharyngitis but without infectious complications
intervention type: Other
intervention name: Collection of data
description: Collection of data on clinical, bacteriological and computed tomography data concerning the case, which will be needed by the adjudication committee and for defining the index date.
arm group label: Cases
intervention type: Other
intervention name: No collection of data
description: The interviewer will note sociodemographic characteristics (age, weight, sex), symptoms and their evolution, and all drug intakes of the patient during the month before the index date.
arm group label: Controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Martin CHALUMEAU, MD, PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Pharyngitis
sharing ipd: No