<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/NCT04451707</url>
  </required_header>
  <id_info>
    <org_study_id>2019/P02/358</org_study_id>
    <nct_id>NCT04451707</nct_id>
  </id_info>
  <brief_title>Epidemiology Non-cholera Vibrio Infections</brief_title>
  <acronym>INFECTIVE</acronym>
  <official_title>Multicentre Retrospective Study on the Clinical and Epidemiological Characteristics and Therapeutic Management of Non-cholera Vibrio Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier de la Rochelle Ré Aunis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier de la Rochelle Ré Aunis</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 purpose of this study is to identify the epidemiological and clinical characteristics of&#xD;
      patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vibrios are gram-negative, ubiquitous bacteria of the marine flora and are found particularly&#xD;
      in warm waters. For example, the incidence is high in Florida and Vibrio infections are now&#xD;
      reportable in the United States. Different species of Vibrio are described. A distinction is&#xD;
      made between choleric vibrios belonging to serogroups O1 and O139, responsible for cholera&#xD;
      epidemics, and non-choleric vibrios. Our study will focus on non-cholera vibrios. Vibrio&#xD;
      infections can occur by eating contaminated raw seafood or by exposure of a wound to the&#xD;
      marine environment. They occur mainly during the hot summer months. This can be explained on&#xD;
      the one hand by higher water temperature and on the other hand by increased beach use. With&#xD;
      global warming, it is possible that Vibrio infections may increase in number and location.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2020</start_date>
  <completion_date type="Actual">June 17, 2020</completion_date>
  <primary_completion_date type="Actual">June 17, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection</measure>
    <time_frame>Up to 20 years, from 2000-2019</time_frame>
    <description>A non-cholerae or non-O1/O139 Vibrio infection was defined by a biological sample (blood, superficial sample, deep sample, and ear sample) positive to a Vibrio species other than Vibrio cholerae O1-O139.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Per Clinical History</measure>
    <time_frame>at inclusion</time_frame>
    <description>Clinical history: diabetes, heart failure, hepatopathy, neoplasia, alcohol use disorder, Immunosuppressive drug, Pre-existing wound, Digestive surgery, Hemopathy, Kidney Disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Associated With Environmental Factors</measure>
    <time_frame>at inclusion</time_frame>
    <description>environmental factors : seafood consumption, bathing/water activity, Injury in the aquatic environment, Walk to the beach, Handling of seafood products, returning from a trip abroad</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Per Identified Species</measure>
    <time_frame>at inclusion</time_frame>
    <description>Species: Vibrio alginolyticus, Vibrio cholerae Non-O1/Non-O139 Non toxinogenic, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio sp or other</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants by Month of the Years</measure>
    <time_frame>at inclusion</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Treated by Antibiotics</measure>
    <time_frame>through study completion, an average of 1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Per Outcome</measure>
    <time_frame>through study completion, an average of 1 month</time_frame>
    <description>outcome :cure, cure with amputation, and deceased due to the infection</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">67</enrollment>
  <condition>Vibrio Infections</condition>
  <arm_group>
    <arm_group_label>non-cholera Vibrio infection</arm_group_label>
    <description>Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-cholera Vibrio infection</intervention_name>
    <description>Epidemiology of patients diagnosed with non-cholera Vibrio infection</description>
    <arm_group_label>non-cholera Vibrio infection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-cholera Vibrio infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  vibriosis to Vibrio cholerae O1 and O139&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florence Hoefler, MD</last_name>
    <role>Study Director</role>
    <affiliation>Groupe Hospitalier de la Rochelle Ré Aunis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Départemental de la Vendée</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Weis KE, Hammond RM, Hutchinson R, Blackmore CG. Vibrio illness in Florida, 1998-2007. Epidemiol Infect. 2011 Apr;139(4):591-8. doi: 10.1017/S0950268810001354. Epub 2010 Jun 14.</citation>
    <PMID>20546636</PMID>
  </reference>
  <reference>
    <citation>Morris JG Jr. Cholera and other types of vibriosis: a story of human pandemics and oysters on the half shell. Clin Infect Dis. 2003 Jul 15;37(2):272-80. doi: 10.1086/375600. Epub 2003 Jul 3.</citation>
    <PMID>12856219</PMID>
  </reference>
  <reference>
    <citation>Givens CE, Bowers JC, DePaola A, Hollibaugh JT, Jones JL. Occurrence and distribution of Vibrio vulnificus and Vibrio parahaemolyticus--potential roles for fish, oyster, sediment and water. Lett Appl Microbiol. 2014 Jun;58(6):503-10. doi: 10.1111/lam.12226. Epub 2014 Feb 27.</citation>
    <PMID>24571291</PMID>
  </reference>
  <reference>
    <citation>Jones MK, Oliver JD. Vibrio vulnificus: disease and pathogenesis. Infect Immun. 2009 May;77(5):1723-33. doi: 10.1128/IAI.01046-08. Epub 2009 Mar 2. No abstract available.</citation>
    <PMID>19255188</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <results_first_submitted>February 19, 2021</results_first_submitted>
  <results_first_submitted_qc>February 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2021</results_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</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>Vibrio Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be made available with publication. Keyword are infection, non-cholera Vibrio, epidemiology The only available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication.&#xD;
Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for will be provided in the publication. International standard unit will be used.</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>From publication and up to 15 years after publication</ipd_time_frame>
    <ipd_access_criteria>Contact the corresponding author of the publication</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT04451707/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
          <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Non-cholera Vibrio Infection</title>
          <description>Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019&#xD;
non-cholera Vibrio infection: Epidemiology of patients diagnosed with non-cholera Vibrio infection</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="67"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.4" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection</title>
        <description>A non-cholerae or non-O1/O139 Vibrio infection was defined by a biological sample (blood, superficial sample, deep sample, and ear sample) positive to a Vibrio species other than Vibrio cholerae O1-O139.</description>
        <time_frame>Up to 20 years, from 2000-2019</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
            <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection</title>
          <description>A non-cholerae or non-O1/O139 Vibrio infection was defined by a biological sample (blood, superficial sample, deep sample, and ear sample) positive to a Vibrio species other than Vibrio cholerae O1-O139.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Center 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Center 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Center 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Center 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Center 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Center 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Center 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Center 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Per Clinical History</title>
        <description>Clinical history: diabetes, heart failure, hepatopathy, neoplasia, alcohol use disorder, Immunosuppressive drug, Pre-existing wound, Digestive surgery, Hemopathy, Kidney Disease</description>
        <time_frame>at inclusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
            <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Per Clinical History</title>
          <description>Clinical history: diabetes, heart failure, hepatopathy, neoplasia, alcohol use disorder, Immunosuppressive drug, Pre-existing wound, Digestive surgery, Hemopathy, Kidney Disease</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Heart failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neoplasia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>kidney failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immune disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haemopathy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alcohol use disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pre-existing wound</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Digestive surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Associated With Environmental Factors</title>
        <description>environmental factors : seafood consumption, bathing/water activity, Injury in the aquatic environment, Walk to the beach, Handling of seafood products, returning from a trip abroad</description>
        <time_frame>at inclusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
            <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Associated With Environmental Factors</title>
          <description>environmental factors : seafood consumption, bathing/water activity, Injury in the aquatic environment, Walk to the beach, Handling of seafood products, returning from a trip abroad</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bathing in the sea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injury in the aquatic environment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aquatic activities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walk on the beach</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Seafood consumption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Handling of seafood products</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Returning from a trip abroad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Per Identified Species</title>
        <description>Species: Vibrio alginolyticus, Vibrio cholerae Non-O1/Non-O139 Non toxinogenic, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio sp or other</description>
        <time_frame>at inclusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
            <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Per Identified Species</title>
          <description>Species: Vibrio alginolyticus, Vibrio cholerae Non-O1/Non-O139 Non toxinogenic, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio sp or other</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vibrio alginolyticus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vibrio parahaemolyticus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-O1/O139 Vibrio cholerae</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vibrio vulnificus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vibrio spp</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants by Month of the Years</title>
        <time_frame>at inclusion</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
            <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants by Month of the Years</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>January</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>February</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>March</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>April</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>May</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>June</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>July</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>August</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>September</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>October</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Novermber</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>December</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Treated by Antibiotics</title>
        <time_frame>through study completion, an average of 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
            <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Treated by Antibiotics</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Treated by antibiotics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Did not received antibiotics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Per Outcome</title>
        <description>outcome :cure, cure with amputation, and deceased due to the infection</description>
        <time_frame>through study completion, an average of 1 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
            <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Per Outcome</title>
          <description>outcome :cure, cure with amputation, and deceased due to the infection</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Cured</title>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Amputation</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Infection related death</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Non-cholerae or Non-O1/O139 Vibrio Infection</title>
          <description>Epidemiology of patients diagnosed with non-cholerae or non-O1/O139 Vibrio infection in Western France from 2000 to 2019</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Amputation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Surgery</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Near Drowning</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Abdominal and gastrointestinal infection</sub_title>
                <description>Severe infection in a patient with cancer</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Necrotizing fasciitis</sub_title>
                <description>patient with blood disease</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Abdominal crampy pain</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Florence Hoefler</name_or_title>
      <organization>Groupe Hospitalier La Rochelle Ré Aunis</organization>
      <phone>+330546455050</phone>
      <email>florence.hoefler@ch-troyes.fr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04451707
org study id: 2019/P02/358
nct id: NCT04451707
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to identify the epidemiological and clinical characteristics of
      patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019.
Vibrios are gram-negative, ubiquitous bacteria of the marine flora and are found particularly
      in warm waters. For example, the incidence is high in Florida and Vibrio infections are now
      reportable in the United States. Different species of Vibrio are described. A distinction is
      made between choleric vibrios belonging to serogroups O1 and O139, responsible for cholera
      epidemics, and non-choleric vibrios. Our study will focus on non-cholera vibrios. Vibrio
      infections can occur by eating contaminated raw seafood or by exposure of a wound to the
      marine environment. They occur mainly during the hot summer months. This can be explained on
      the one hand by higher water temperature and on the other hand by increased beach use. With
      global warming, it is possible that Vibrio infections may increase in number and location.
observational model: Cohort
time perspective: Retrospective
measure: Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection
time frame: Up to 20 years, from 2000-2019
description: A non-cholerae or non-O1/O139 Vibrio infection was defined by a biological sample (blood, superficial sample, deep sample, and ear sample) positive to a Vibrio species other than Vibrio cholerae O1-O139.
measure: Number of Patients Per Clinical History
time frame: at inclusion
description: Clinical history: diabetes, heart failure, hepatopathy, neoplasia, alcohol use disorder, Immunosuppressive drug, Pre-existing wound, Digestive surgery, Hemopathy, Kidney Disease
measure: Number of Participants Associated With Environmental Factors
time frame: at inclusion
description: environmental factors : seafood consumption, bathing/water activity, Injury in the aquatic environment, Walk to the beach, Handling of seafood products, returning from a trip abroad
measure: Number of Participants Per Identified Species
time frame: at inclusion
description: Species: Vibrio alginolyticus, Vibrio cholerae Non-O1/Non-O139 Non toxinogenic, Vibrio parahaemolyticus, Vibrio vulnificus, Vibrio sp or other
measure: Number of Participants by Month of the Years
time frame: at inclusion
measure: Number of Participants Treated by Antibiotics
time frame: through study completion, an average of 1 month
measure: Number of Participants Per Outcome
time frame: through study completion, an average of 1 month
description: outcome :cure, cure with amputation, and deceased due to the infection
arm group label: non-cholera Vibrio infection
description: Patients diagnosed with non-cholera Vibrio infection in Western France from 2000 to 2019
intervention type: Other
intervention name: non-cholera Vibrio infection
description: Epidemiology of patients diagnosed with non-cholera Vibrio infection
arm group label: non-cholera Vibrio infection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Florence Hoefler, MD
role: Study Director
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Weis KE, Hammond RM, Hutchinson R, Blackmore CG. Vibrio illness in Florida, 1998-2007. Epidemiol Infect. 2011 Apr;139(4):591-8. doi: 10.1017/S0950268810001354. Epub 2010 Jun 14.
PMID: 20546636
citation: Morris JG Jr. Cholera and other types of vibriosis: a story of human pandemics and oysters on the half shell. Clin Infect Dis. 2003 Jul 15;37(2):272-80. doi: 10.1086/375600. Epub 2003 Jul 3.
PMID: 12856219
citation: Givens CE, Bowers JC, DePaola A, Hollibaugh JT, Jones JL. Occurrence and distribution of Vibrio vulnificus and Vibrio parahaemolyticus--potential roles for fish, oyster, sediment and water. Lett Appl Microbiol. 2014 Jun;58(6):503-10. doi: 10.1111/lam.12226. Epub 2014 Feb 27.
PMID: 24571291
citation: Jones MK, Oliver JD. Vibrio vulnificus: disease and pathogenesis. Infect Immun. 2009 May;77(5):1723-33. doi: 10.1128/IAI.01046-08. Epub 2009 Mar 2. No abstract available.
PMID: 19255188
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Vibrio Infections
sharing ipd: Yes
ipd description: Data will be made available with publication. Keyword are infection, non-cholera Vibrio, epidemiology The only available version will be the locked database. The database will be made available by the study director upon request up to 15 years after publication.
Medical Subject Headings (MESH) terms will be used to describe clinical data. Methodology for will be provided in the publication. International standard unit will be used.
ipd info type: Clinical Study Report (CSR)
ipd time frame: From publication and up to 15 years after publication
ipd access criteria: Contact the corresponding author of the publication
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 