<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/NCT03768635</url>
  </required_header>
  <id_info>
    <org_study_id>18-284</org_study_id>
    <nct_id>NCT03768635</nct_id>
  </id_info>
  <brief_title>Necrotizing External Otitis : Study in a Regional Bone and Joint Infection Reference Center</brief_title>
  <official_title>Necrotizing External Otitis : Study in a Regional Bone and Joint Infection</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>
      The malignant external otitis is a rare disease which arises more frequently at the elderly&#xD;
      and the diabetics patients. To our knowledge, there are few data and it is not wellc known&#xD;
      byclinicians. Nevertheless it exposes to neurological complications potentially serious and&#xD;
      crippling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2006</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</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>Rate of necrotizing external otitis</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>description of necrotizing external otitis: patients, profile of the bacterium, medical and chirurgical treatment, rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Treatment Failure</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of antibiotics</measure>
    <time_frame>Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption</time_frame>
    <description>Description of the strategies of antibiotic treatments used (double-agent therapy, monotherapy, duration)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">53</enrollment>
  <condition>Bone and Joint Infection</condition>
  <arm_group>
    <arm_group_label>Necrotizing external otitis</arm_group_label>
    <description>description of necrotizing external otitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>necrotizing external otitis</intervention_name>
    <description>description of necrotizing external otitis</description>
    <arm_group_label>Necrotizing external otitis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients having had necrotizing external otitis and managed at the Lyon Bone and joint&#xD;
        infection refence Center between 01/01/2006 and 31/01/2018&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients having had necrotizing external otitis and managed at the Lyon Bone and joint&#xD;
             infection refence Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Tristan Ferry, Md, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospices Civils de Lyon</investigator_affiliation>
    <investigator_full_name>Eugénie MABRUT</investigator_full_name>
    <investigator_title>Clinical Reseacrh Assistant</investigator_title>
  </responsible_party>
  <keyword>otitis</keyword>
  <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>Arthritis, Infectious</mesh_term>
    <mesh_term>Otitis</mesh_term>
    <mesh_term>Otitis Externa</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/NCT03768635
org study id: 18-284
nct id: NCT03768635
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The malignant external otitis is a rare disease which arises more frequently at the elderly
      and the diabetics patients. To our knowledge, there are few data and it is not wellc known
      byclinicians. Nevertheless it exposes to neurological complications potentially serious and
      crippling.
observational model: Cohort
time perspective: Retrospective
measure: Rate of necrotizing external otitis
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: description of necrotizing external otitis: patients, profile of the bacterium, medical and chirurgical treatment, rate
measure: Rate of Treatment Failure
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin. Analyse of risk factor.
measure: Duration of antibiotics
time frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption
description: Description of the strategies of antibiotic treatments used (double-agent therapy, monotherapy, duration)
arm group label: Necrotizing external otitis
description: description of necrotizing external otitis
intervention type: Other
intervention name: necrotizing external otitis
description: description of necrotizing external otitis
arm group label: Necrotizing external otitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
last name: Tristan Ferry, Md, PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hospices Civils de Lyon
investigator full name: Eugénie MABRUT
investigator title: Clinical Reseacrh Assistant
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Arthritis, Infectious
mesh term: Otitis
mesh term: Otitis Externa
sharing ipd: Undecided