<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/NCT04483232</url>
  </required_header>
  <id_info>
    <org_study_id>AMOUREUX FPA 2020</org_study_id>
    <nct_id>NCT04483232</nct_id>
  </id_info>
  <brief_title>Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.</brief_title>
  <acronym>AERIO</acronym>
  <official_title>Achromobacter Spp: Description of Epidemiology and Resistance in Chronic Ear Infections and in Healthy Individuals.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus&#xD;
      Achromobacter is not known in these conditions. An epidemiological study including a large&#xD;
      number of patients is needed to compare the prevalence of these bacteria in sick and healthy&#xD;
      subjects, and to highlight the characteristics of the strains and the factors favouring their&#xD;
      emergence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Achromobacter positive sample number</measure>
    <time_frame>Through study completion, an average of 3 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1800</enrollment>
  <condition>Achromobacter</condition>
  <condition>Epidemiology</condition>
  <condition>Chronic Ear Infection</condition>
  <arm_group>
    <arm_group_label>Healthy Subjects</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with ear infections</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ear canal swab</intervention_name>
    <description>Ear canal swab</description>
    <arm_group_label>Healthy Subjects</arm_group_label>
    <arm_group_label>Patients with ear infections</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        -  Protected adult (curatorship, guardianship)&#xD;
&#xD;
          -  Person deprived of their liberty by judicial or administrative decision&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding woman&#xD;
&#xD;
          -  Adult unable to give consent&#xD;
&#xD;
          -  For healthy subjects:&#xD;
&#xD;
               -  current ear infection or within the last 6 months&#xD;
&#xD;
               -  Antibiotics (local or systemic) taken within the previous month&#xD;
&#xD;
          -  For sick subjects who have already been included once, new episode &lt; 3 months after&#xD;
             the previous one&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Person or parent who has given his or her non-opposition&#xD;
&#xD;
          -  Person over 10 years of age&#xD;
&#xD;
          -  Sick Subjects Group :&#xD;
&#xD;
        diagnosis of chronic infection by an ENT specialist doctor if patient already included: new&#xD;
        episode &gt; 3 months after the complete clinical recovery from the previous episode observed&#xD;
        by the ENT doctor - Healthy group: no ear infection in the last 6 months and no antibiotics&#xD;
        in the previous month.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lucie AMOUREUX</last_name>
    <phone>03.80.29.56.86</phone>
    <phone_ext>+33</phone_ext>
    <email>lucie.amoureux@chu-dijon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chu Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21000</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Lucie AMOUREUX</last_name>
      <phone>03.80.29.56.86</phone>
      <phone_ext>+33</phone_ext>
      <email>lucie.amoureux@chu-dijon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Otitis</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/NCT04483232
org study id: AMOUREUX FPA 2020
nct id: NCT04483232
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hearing loss can be the result of chronic ear infections. The role of bacteria of the genus
      Achromobacter is not known in these conditions. An epidemiological study including a large
      number of patients is needed to compare the prevalence of these bacteria in sick and healthy
      subjects, and to highlight the characteristics of the strains and the factors favouring their
      emergence.
observational model: Cohort
time perspective: Prospective
measure: Achromobacter positive sample number
time frame: Through study completion, an average of 3 years
arm group label: Healthy Subjects
arm group label: Patients with ear infections
intervention type: Biological
intervention name: Ear canal swab
description: Ear canal swab
arm group label: Healthy Subjects
arm group label: Patients with ear infections
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lucie AMOUREUX
phone: 03.80.29.56.86
phone ext: +33
email: lucie.amoureux@chu-dijon.fr
facility: 
contact: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Otitis