<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/NCT04447521</url>
  </required_header>
  <id_info>
    <org_study_id>STREPTO1.2</org_study_id>
    <nct_id>NCT04447521</nct_id>
  </id_info>
  <brief_title>Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium</brief_title>
  <acronym>STREPTO</acronym>
  <official_title>A 20-months Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium to Evaluate National Vaccination Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sciensano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sciensano</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>
      The investigators will conduct a prospective observational study of non-invasive S.&#xD;
      pneumoniae infections in Belgium and characterize serotype distributions to evaluate national&#xD;
      vaccination programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a surveillance of non-invasive S. pneumoniae infections in&#xD;
      Belgium (September 2020-May 2025). Monthly, 12 peripheral hospitals will send the first 15&#xD;
      unduplicated clinical S. pneumoniae samples (coming from patients diagnosed with pneumonia,&#xD;
      otitits media or sinusitis) to the investigators. The investigators will determine the&#xD;
      serotype and the antibiotic resistance profile of these clinical isolates. Whole genome&#xD;
      sequencing will be performed on a subset of these isolates.&#xD;
&#xD;
      From May 2021, 13 extra participating centers have been added to the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 1, 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>Establish insight in serotype dynamics for non-invasive pneumococcal diseases in Belgium prospectively, in association with changing vaccination programs (campaigns).</measure>
    <time_frame>September 2020-May 2025</time_frame>
    <description>There is a wealth of information available on the serotype distribution of S. pneumoniae causing inavsive pneumococcal disease (IPD). However, much less is known about the serotype distribution of S. pneumoniae causing non-invasive pneumococcal disease (NIPD). The goal of this study is to characterize the serotype distribution of of S. pneumoniae causing NIPD in Belgium, compare is with IPD data and link it with the changing national vaccinations programs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surveillance of emerging serotypes, clones and drug resistances. Study of the genetic divergences between invasive and non-invasive pneumococcal diseases isolates.</measure>
    <time_frame>September 2020-May 2025</time_frame>
    <description>To date, little is known about serotype distribution in NIPD and how this relate with the more widely studied serotype distribution in IPD. This study aims to shed light onto this topic.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">3600</enrollment>
  <condition>Pneumonia</condition>
  <condition>Otitis Media</condition>
  <condition>Sinusitis Bacterial</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Streptococcus pneumoniae samples will be collected and stored during the time frame of this&#xD;
      study.&#xD;
&#xD;
      DNA extraction and whole-genome sequencing will be performed for a subset of these strains.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from non-invasive pneumococcal disease (diagnosed as CAP, sinusitis and&#xD;
        otitits media) and living in Belgium at the time of the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients living in Belgium at the time of the study,&#xD;
&#xD;
          -  from whom unduplicated S. pneumoniae isolates were collected in routine practices,&#xD;
&#xD;
          -  from non-invasive upper (e.g.: pus/fluid from nasal sinus or from otitis media fluid)&#xD;
             or lower respiratory tract (e.g. sputum bronchial or endotracheal aspirate,&#xD;
             bronchoalveolar fluid (BAL),…) clinical samples,&#xD;
&#xD;
          -  from patients diagnosed with pneumonia, sinusitis and otitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients for whom S. pneumoniae was simultaneously isolated from blood or another usually&#xD;
        sterile specimen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pieter-Jan Ceyssens, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sciensano</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pieter-Jan Ceyssens, PhD</last_name>
    <phone>02 373 31 19</phone>
    <phone_ext>+32</phone_ext>
    <email>pieter-jan.ceyssens@sciensano.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ioannis Passaris, PhD</last_name>
    <phone>02 373 33 23</phone>
    <phone_ext>+32</phone_ext>
    <email>ioannis.passaris@sciensano.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sciensano</name>
      <address>
        <city>Brussels</city>
        <zip>1180</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pieter-Jan Ceyssens, PhD</last_name>
      <phone>02 373 31 19</phone>
      <phone_ext>+32</phone_ext>
      <email>pieter-jan.ceyssens@sciensano.be</email>
    </contact>
    <contact_backup>
      <last_name>Ioannis Passaris, PhD</last_name>
      <phone>02 373 33 23</phone>
      <phone_ext>+32</phone_ext>
      <email>ioannis.passaris@sciensano.be</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>October 25, 2022</last_update_submitted>
  <last_update_submitted_qc>October 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2022</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>Pneumonia</mesh_term>
    <mesh_term>Sinusitis</mesh_term>
    <mesh_term>Pneumonia, Pneumococcal</mesh_term>
    <mesh_term>Pneumococcal Infections</mesh_term>
    <mesh_term>Otitis Media</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT04447521/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04447521
org study id: STREPTO1.2
nct id: NCT04447521
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators will conduct a prospective observational study of non-invasive S.
      pneumoniae infections in Belgium and characterize serotype distributions to evaluate national
      vaccination programs.
The investigators will conduct a surveillance of non-invasive S. pneumoniae infections in
      Belgium (September 2020-May 2025). Monthly, 12 peripheral hospitals will send the first 15
      unduplicated clinical S. pneumoniae samples (coming from patients diagnosed with pneumonia,
      otitits media or sinusitis) to the investigators. The investigators will determine the
      serotype and the antibiotic resistance profile of these clinical isolates. Whole genome
      sequencing will be performed on a subset of these isolates.

      From May 2021, 13 extra participating centers have been added to the study.
observational model: Case-Only
time perspective: Prospective
measure: Establish insight in serotype dynamics for non-invasive pneumococcal diseases in Belgium prospectively, in association with changing vaccination programs (campaigns).
time frame: September 2020-May 2025
description: There is a wealth of information available on the serotype distribution of S. pneumoniae causing inavsive pneumococcal disease (IPD). However, much less is known about the serotype distribution of S. pneumoniae causing non-invasive pneumococcal disease (NIPD). The goal of this study is to characterize the serotype distribution of of S. pneumoniae causing NIPD in Belgium, compare is with IPD data and link it with the changing national vaccinations programs.
measure: Surveillance of emerging serotypes, clones and drug resistances. Study of the genetic divergences between invasive and non-invasive pneumococcal diseases isolates.
time frame: September 2020-May 2025
description: To date, little is known about serotype distribution in NIPD and how this relate with the more widely studied serotype distribution in IPD. This study aims to shed light onto this topic.
Streptococcus pneumoniae samples will be collected and stored during the time frame of this
      study.

      DNA extraction and whole-genome sequencing will be performed for a subset of these strains.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pieter-Jan Ceyssens, PhD
role: Principal Investigator
affiliation: Sciensano
last name: Pieter-Jan Ceyssens, PhD
phone: 02 373 31 19
phone ext: +32
email: pieter-jan.ceyssens@sciensano.be
last name: Ioannis Passaris, PhD
phone: 02 373 33 23
phone ext: +32
email: ioannis.passaris@sciensano.be
facility: 
status: Recruiting
contact: 
contact backup: 
country: Belgium
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Sinusitis
mesh term: Pneumonia, Pneumococcal
mesh term: Pneumococcal Infections
mesh term: Otitis Media
provided document: 