xml: <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/NCT06036628</url>
    </required_header>
    <id_info>
      <org_study_id>BREF</org_study_id>
      <nct_id>NCT06036628</nct_id>
    </id_info>
    <brief_title>Resistant Bacteria in Children in France</brief_title>
    <acronym>BREF</acronym>
    <official_title>National Surveillance of the Use of New Antibiotics in Pediatrics and Multi- Resistant Bacteria Involved in Pediatric Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Association Clinique Thérapeutique Infantile du val de Marne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        This study is observational, multicenter and prospective study for surveillance of the use of&#xD;
        new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant&#xD;
        bacteria&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main of this study is to evaluate the relevance of prescribing &quot;new antibiotics&quot;&#xD;
        according to the antibiogram of the isolated bacteria or in the absence of bacteriological&#xD;
        documentation&#xD;
  &#xD;
        As this is a surveillance study, the clinical and biological characteristics of the children&#xD;
        included will be described.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Relevance of prescribing &quot;new antibiotics&quot; according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation</measure>
      <time_frame>1 year</time_frame>
      <description>Type of new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria, and how are they used</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Describe Bacterial epidemiology of infections associated with prescription of new antibiotics</measure>
      <time_frame>1 year</time_frame>
      <description>Characteristic of bacteria associated with prescription of new antibiotics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Identify Risks factors for multi-resistant bacteria</measure>
      <time_frame>1 year</time_frame>
      <description>Type of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Discribe Context of drug Prescription</measure>
      <time_frame>1 year</time_frame>
      <description>Number, type of departement involved and How antibiotics prescriptions are controlled and validated</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe Associated Antibiotherapies</measure>
      <time_frame>1 year</time_frame>
      <description>Number and type of drug association prescribed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe patients outcome</measure>
      <time_frame>1 year</time_frame>
      <description>Proportion of patients clinically and bacteriologically recovered</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Infection Due to Resistant Bacteria</condition>
    <condition>Multi-antibiotic Resistance</condition>
    <condition>Antibiotic Prescription</condition>
    <condition>Risk Factors</condition>
    <condition>Healing</condition>
    <condition>Complications</condition>
    <condition>Intensive Care Unit</condition>
    <condition>Hospital Discharge</condition>
    <condition>Outcome, Fatal</condition>
    <eligibility>
      <study_pop>
        <textblock>
          pediatrics patients infected by multi-resistant bacterial, treated by new antibiotics&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children under 18 years of age&#xD;
  &#xD;
            -  Hospitalized in France in a hospital center working with the ACTIV/GPIP network&#xD;
  &#xD;
            -  Treated with one or more of the following antibiotics:&#xD;
  &#xD;
                 -  Colimycin (Colistimethate sodium)&#xD;
  &#xD;
                 -  Cefiderocol&#xD;
  &#xD;
                 -  Aztreonam in combination&#xD;
  &#xD;
                 -  Ceftolozane-Tazobactam&#xD;
  &#xD;
                 -  Ceftazidime-avibactam&#xD;
  &#xD;
                 -  Meropenem/vaborbactam&#xD;
  &#xD;
                 -  Imipenem/Relebactam&#xD;
  &#xD;
                 -  Tigecycline&#xD;
  &#xD;
                 -  Daptomycin&#xD;
  &#xD;
                 -  Ceftaroline fosamil&#xD;
  &#xD;
                 -  Tedizolid phosphate&#xD;
  &#xD;
                 -  Fidaxomicin&#xD;
  &#xD;
                 -  Ceftobiprole&#xD;
  &#xD;
                 -  Dalbavancin&#xD;
  &#xD;
          In association with a documented infection performed by:&#xD;
  &#xD;
            -  Blood culture&#xD;
  &#xD;
            -  Normally sterile site&#xD;
  &#xD;
                 -  Cerebrospinal fluid&#xD;
  &#xD;
                 -  Pleural fluid&#xD;
  &#xD;
                 -  Pleura&#xD;
  &#xD;
                 -  Peritoneum&#xD;
  &#xD;
                 -  Joint fluid&#xD;
  &#xD;
                 -  Other&#xD;
  &#xD;
            -  Urine sampling if the bacteria was considered responsible for the infection&#xD;
               (associated with a leukocyturia ≥10,0000)&#xD;
  &#xD;
            -  Respiratory specimens if the bacteria was considered responsible for the infection&#xD;
  &#xD;
            -  Sampling on material such as:Intubation probe, Orthopedic, Urological, Central Nervous&#xD;
               System (CNS),....&#xD;
  &#xD;
                 -  Related to colonization with multidrug-resistant bacteria without documentation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal of participation by the patient or his/her parent&#xD;
  &#xD;
            -  Medical history of mucoviscidosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>17 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Levy Corinne</last_name>
      <role>Study Director</role>
      <affiliation>Association Clinique Thérapeutique Infantile du val de Marne</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Cohen Robert</last_name>
      <role>Principal Investigator</role>
      <affiliation>Association Clinique Thérapeutique Infantile du val de Marne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Levy Corinne</last_name>
      <phone>1 48 85 04 04</phone>
      <phone_ext>+33</phone_ext>
      <email>corinne.levy@activ-france.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Bechet Stephane</last_name>
      <phone>1 48 85 96 68</phone>
      <phone_ext>+33</phone_ext>
      <email>stephane.bechet@activ-france.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>ACTIV</name>
        <address>
          <city>Créteil</city>
          <zip>94000</zip>
          <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>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</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 14, 2023</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>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036628
  org study id: BREF
  nct id: NCT06036628
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is observational, multicenter and prospective study for surveillance of the use of
        new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant
        bacteria
  The main of this study is to evaluate the relevance of prescribing "new antibiotics"
        according to the antibiogram of the isolated bacteria or in the absence of bacteriological
        documentation
  
        As this is a surveillance study, the clinical and biological characteristics of the children
        included will be described.
  observational model: Case-Only
  time perspective: Prospective
  measure: Relevance of prescribing "new antibiotics" according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation
  time frame: 1 year
  description: Type of new antibiotics prescribed for pediatrics infections caused by multi-resistant bacteria, and how are they used
  measure: Describe Bacterial epidemiology of infections associated with prescription of new antibiotics
  time frame: 1 year
  description: Characteristic of bacteria associated with prescription of new antibiotics
  measure: Identify Risks factors for multi-resistant bacteria
  time frame: 1 year
  description: Type of conditions responsible of multi-resistant such as comorbidities, travel, previous hospitalization, previous antibiotherapy,
  measure: Discribe Context of drug Prescription
  time frame: 1 year
  description: Number, type of departement involved and How antibiotics prescriptions are controlled and validated
  measure: Describe Associated Antibiotherapies
  time frame: 1 year
  description: Number and type of drug association prescribed
  measure: Describe patients outcome
  time frame: 1 year
  description: Proportion of patients clinically and bacteriologically recovered
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 17 Years
  healthy volunteers: No
  last name: Levy Corinne
  role: Study Director
  affiliation: Association Clinique Thérapeutique Infantile du val de Marne
  last name: Cohen Robert
  role: Principal Investigator
  affiliation: Association Clinique Thérapeutique Infantile du val de Marne
  last name: Levy Corinne
  phone: 1 48 85 04 04
  phone ext: +33
  email: corinne.levy@activ-france.fr
  last name: Bechet Stephane
  phone: 1 48 85 96 68
  phone ext: +33
  email: stephane.bechet@activ-france.fr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: France
  responsible party type: Sponsor
  mesh term: Infections