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/NCT06030505</url>
    </required_header>
    <id_info>
      <org_study_id>ENVIE</org_study_id>
      <secondary_id>2023-A01803-42</secondary_id>
      <nct_id>NCT06030505</nct_id>
    </id_info>
    <brief_title>Effectiveness of Nirsevimab in Children Hospitalised With Bronchiolitis</brief_title>
    <acronym>ENVIE</acronym>
    <official_title>Effectiveness of Nirsevimab in Children Hospitalised With Bronchiolitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Intercommunal Creteil</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Association Clinique Thérapeutique Infantile du val de Marne</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Groupe de Pathologies Infectieuses Pédiatriques (GPIP</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre Hospitalier Intercommunal Creteil</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>
        Respiratory tract infections caused by respiratory syncytial virus (RSV) are a worldwide&#xD;
        burden and represent a major public health issue. In France, bronchiolitis is responsible for&#xD;
        around 100,000 emergency room visits and 50,000 hospital admissions every year; 75% of&#xD;
        infants hospitalised for RSV bronchiolitis are healthy full-term children.&#xD;
  &#xD;
        Recent discoveries concerning the specific viral epitopes of RSV have made it possible to&#xD;
        move from an empirical approach to a targeted preventive or curative approach (monoclonal&#xD;
        antibodies, vaccines, anti-viral drugs).&#xD;
  &#xD;
        Nirsevimab is a monoclonal antibody against RSV with enhanced neutralising activity and a&#xD;
        prolonged half-life. A randomised, placebo-controlled phase III trial demonstrated the&#xD;
        effectiveness of nirsevimab in reducing lower respiratory tract infections caused by RSV&#xD;
        requiring medical management in healthy premature and term infants, with a favourable safety&#xD;
        profile. The US Food and Drug Administration (FDA) approved the first RSV vaccine on May 3,&#xD;
        2023, and the second was approved on May 31, 2023. Nirsevimab was approved by the European&#xD;
        Medicines Agency (EMA) on November 4, 2022.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">July 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 15, 2024</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>Proportion of patients passively immunised with nirsevimab</measure>
      <time_frame>1 month</time_frame>
      <description>Proportion of patients passively immunised with nirsevimab in children hospitalised with RSV bronchiolitis and in the control group</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of hospitalised children for bronchiolitis passively immunised with nirsevimab</measure>
      <time_frame>1 month</time_frame>
      <description>Proportion of children passively immunised with nirsevimab hospitalised for bronchiolitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of hospitalised children for bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab</measure>
      <time_frame>1 month</time_frame>
      <description>Proportion of children passively immunised with nirsevimab hospitalised for bronchiolitis requiring invasive or non-invasive ventilatory support, including RSV bronchiolitis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>1 month</time_frame>
      <description>Length of hospital stay for children with bronchiolitis, including RSV bronchiolitis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time immunisation</measure>
      <time_frame>1 month</time_frame>
      <description>Time between immunisation with nirsevimab and hospitalisation for RSV bronchiolitis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frequency of hospital admissions</measure>
      <time_frame>1 month</time_frame>
      <description>Monthly frequency of hospital admissions for bronchiolitis among participating centres over time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fall in bronchiolitis attributable to the nirsevimab</measure>
      <time_frame>1 month</time_frame>
      <description>Fraction of the fall in bronchiolitis attributable to the nirsevimab immunisation campaign</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of children hospitalised for bronchiolitis with viral co-detection</measure>
      <time_frame>1 month</time_frame>
      <description>Proportion of children hospitalised for bronchiolitis with viral co-detection or viral detection other than RSV on nasopharyngeal swab</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">705</enrollment>
    <condition>Bronchiolitis, Viral</condition>
    <arm_group>
      <arm_group_label>Case patients</arm_group_label>
      <description>Collection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control patients</arm_group_label>
      <description>Collection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention required by the protocol</intervention_name>
      <description>No visits or samples will be taken specifically for this study. This research involves only prospective or retrospective data collection in relation to the usual hospital management of the child included. Similarly, patient follow-up will be strictly within the framework of their usual hospital care in relation to their pathology.</description>
      <arm_group_label>Case patients</arm_group_label>
      <arm_group_label>Control patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Paediatric patients under 12 months of age treated for bronchiolitis (for cases), or for&#xD;
          one of the conditions listed in the inclusion criteria (for controls).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Cases :&#xD;
  &#xD;
            -  Children under 12 months of age&#xD;
  &#xD;
            -  Treated for acute bronchiolitis defined according to current national and&#xD;
               international recommendations.&#xD;
  &#xD;
            -  Admitted to paediatric emergency department.&#xD;
  &#xD;
          Controls :&#xD;
  &#xD;
            -  Children under 12 months&#xD;
  &#xD;
            -  Cared for at one of the study sites&#xD;
  &#xD;
            -  From 15 October 2023&#xD;
  &#xD;
            -  For one of the following reasons&#xD;
  &#xD;
            -  Febrile urinary tract infection, without acute ear, nose, and throat (ENT) or&#xD;
               respiratory symptoms&#xD;
  &#xD;
            -  Acute gastroenteritis, without acute ENT or respiratory symptoms&#xD;
  &#xD;
            -  Infant colic without fever, without ENT or acute respiratory symptoms&#xD;
  &#xD;
            -  Stagnant weight or feeding difficulties without fever, acute ENT or respiratory&#xD;
               symptoms&#xD;
  &#xD;
            -  Neonatal jaundice without fever or acute ENT or respiratory symptoms&#xD;
  &#xD;
            -  Unexplained crying without fever, without ENT or acute respiratory symptoms&#xD;
  &#xD;
            -  Head injury, without acute ENT or respiratory symptoms&#xD;
  &#xD;
            -  Patient hospitalised for acute surgery without fever, without ENT or acute respiratory&#xD;
               symptoms&#xD;
  &#xD;
            -  Hospitalised in the conventional sector or in a short-term hospital unit, or cared for&#xD;
               on an outpatient basis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to participate by the patient, their relative or legal representative&#xD;
  &#xD;
            -  Administration of Palivizumab.&#xD;
  &#xD;
            -  Maternal vaccination against RSV.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>1 Year</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Camille JUNG</last_name>
      <phone>0145175000</phone>
      <phone_ext>+33</phone_ext>
      <email>camille.jung@chicreteil.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Bondy - Jean Verdier</name>
        <address>
          <city>Bondy</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Camille AUPIAIS</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHI Créteil</name>
        <address>
          <city>Créteil</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Mickaël SHUM</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU Robert-Debré</name>
        <address>
          <city>Paris</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Naïm OULDALI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>CHU Toulouse-hôpital des Enfants</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 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>Bronchiolitis</mesh_term>
      <mesh_term>Bronchiolitis, Viral</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06030505
  org study id: ENVIE
  secondary id: 2023-A01803-42
  nct id: NCT06030505
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Respiratory tract infections caused by respiratory syncytial virus (RSV) are a worldwide
        burden and represent a major public health issue. In France, bronchiolitis is responsible for
        around 100,000 emergency room visits and 50,000 hospital admissions every year; 75% of
        infants hospitalised for RSV bronchiolitis are healthy full-term children.
  
        Recent discoveries concerning the specific viral epitopes of RSV have made it possible to
        move from an empirical approach to a targeted preventive or curative approach (monoclonal
        antibodies, vaccines, anti-viral drugs).
  
        Nirsevimab is a monoclonal antibody against RSV with enhanced neutralising activity and a
        prolonged half-life. A randomised, placebo-controlled phase III trial demonstrated the
        effectiveness of nirsevimab in reducing lower respiratory tract infections caused by RSV
        requiring medical management in healthy premature and term infants, with a favourable safety
        profile. The US Food and Drug Administration (FDA) approved the first RSV vaccine on May 3,
        2023, and the second was approved on May 31, 2023. Nirsevimab was approved by the European
        Medicines Agency (EMA) on November 4, 2022.
  observational model: Case-Control
  time perspective: Prospective
  measure: Proportion of patients passively immunised with nirsevimab
  time frame: 1 month
  description: Proportion of patients passively immunised with nirsevimab in children hospitalised with RSV bronchiolitis and in the control group
  measure: Proportion of hospitalised children for bronchiolitis passively immunised with nirsevimab
  time frame: 1 month
  description: Proportion of children passively immunised with nirsevimab hospitalised for bronchiolitis
  measure: Proportion of hospitalised children for bronchiolitis requiring invasive or non-invasive ventilatory passively immunised with nirsevimab
  time frame: 1 month
  description: Proportion of children passively immunised with nirsevimab hospitalised for bronchiolitis requiring invasive or non-invasive ventilatory support, including RSV bronchiolitis
  measure: Length of hospital stay
  time frame: 1 month
  description: Length of hospital stay for children with bronchiolitis, including RSV bronchiolitis.
  measure: Time immunisation
  time frame: 1 month
  description: Time between immunisation with nirsevimab and hospitalisation for RSV bronchiolitis.
  measure: Frequency of hospital admissions
  time frame: 1 month
  description: Monthly frequency of hospital admissions for bronchiolitis among participating centres over time
  measure: fall in bronchiolitis attributable to the nirsevimab
  time frame: 1 month
  description: Fraction of the fall in bronchiolitis attributable to the nirsevimab immunisation campaign
  measure: Proportion of children hospitalised for bronchiolitis with viral co-detection
  time frame: 1 month
  description: Proportion of children hospitalised for bronchiolitis with viral co-detection or viral detection other than RSV on nasopharyngeal swab
  arm group label: Case patients
  description: Collection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research.
  arm group label: Control patients
  description: Collection of medical data in a non-identifying way (demographic data, medical history, clinical data, microbiological data) to meet the objectives of the research.
  intervention type: Other
  intervention name: No intervention required by the protocol
  description: No visits or samples will be taken specifically for this study. This research involves only prospective or retrospective data collection in relation to the usual hospital management of the child included. Similarly, patient follow-up will be strictly within the framework of their usual hospital care in relation to their pathology.
  arm group label: Case patients
  arm group label: Control patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 1 Year
  healthy volunteers: No
  last name: Camille JUNG
  phone: 0145175000
  phone ext: +33
  email: camille.jung@chicreteil.fr
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  country: France
  responsible party type: Sponsor
  mesh term: Bronchiolitis
  mesh term: Bronchiolitis, Viral
  sharing ipd: No