<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/NCT03010007</url>
  </required_header>
  <id_info>
    <org_study_id>Influenza in Basel 2016/2017</org_study_id>
    <nct_id>NCT03010007</nct_id>
  </id_info>
  <brief_title>Prospective Analysis of Seasonal Influenza - Viral Transmission and Evolution in the City of Basel, Switzerland</brief_title>
  <official_title>Prospective Analysis of Seasonal Influenza - Viral Transmission and Evolution in the City of Basel, Switzerland [Prospektive Systemanalyse Der Saisonalen Influenza - Virustransmission Und Evolution in Der Stadt Basel] in German</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Swiss Federal Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Children's Hospital Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Basel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Influenza associated illness has a global annual impact with high morbidity and mortality.&#xD;
      Transmission mechanisms and rates are under-investigated and overall poorly understood.&#xD;
&#xD;
      This project aims to use epidemiological tools to understand the transmission and evolution&#xD;
      of influenza viruses at an individual and population level within a small-scale city (Basel)&#xD;
      through a combination of experimental, clinical and mathematical advances. The investigators&#xD;
      aim to quantitatively characterize the viral transmission using novel&#xD;
      molecular-epidemiological tools based on whole genome sequencing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective observational study, paediatric and adult outpatients presenting with&#xD;
      influenza-like illness will be enrolled at the emergency departments of the University&#xD;
      Hospital Basel (USB), the paediatric University Hospital of both Basel (UKBB), or a network&#xD;
      of family doctors (associated with Center of Primary Health Care).&#xD;
&#xD;
      The Clinical Trial Unit at the University Hospital Basel will coordinated the recruitment&#xD;
      process, collect data and sample all patients during the influenza season 2016/17. Samples&#xD;
      will be collected such as whole blood, serum and DNA, nasopharyngeal swamps to diagnose&#xD;
      influenza by polymerase chain reaction (PCR) assay and to determine colonization rates with&#xD;
      Staphylococcus aureus and Streptococcus pneumonia. All samples except the first&#xD;
      naso-pharyngeal swab for influenza diagnostics will be stored in a biobank and analysed in&#xD;
      batches. Each influenza virus isolate will be sequenced using a &quot;whole genome sequencing&quot;&#xD;
      approach. The viral transmission and evolution will be analysed using whole genome data for a&#xD;
      detailed molecular and phylogenetic tree analysis, respectively. The epidemiological and&#xD;
      geographical data will be incorporated into the phylogenetic model.&#xD;
&#xD;
      Specific aims are:&#xD;
&#xD;
      (i) to determine the impact of the most important epidemiological parameters, first focusing&#xD;
      on the age profile, followed by children per house hold, and population density, on influenza&#xD;
      transmission at an individual and population level, drawing on an analysis of baseline&#xD;
      humoral immunity and whole genome sequencing data, (ii) to understand the viral evolution&#xD;
      during seasonal epidemics, (iii) to develop dynamic mathematical models that are able to&#xD;
      predict viral transmission and evolution based on the retrospective results from (i) and (ii)&#xD;
      and to validate this model in future influenza seasons.&#xD;
&#xD;
      To realize the interdisciplinary approach, the investigators will rely on the expertise in&#xD;
      mathematical modelling of viral epidemiology and evolution and established geographical&#xD;
      expertise, next generation sequencing, clinical epidemiology, and immunologic diagnostic&#xD;
      techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Investigation of the phylogenetic relation of viral isolates from participating patients using whole-genome sequencing and bioinformatics</measure>
    <time_frame>Baseline</time_frame>
    <description>The primary microbiological endpoint is the connection of two viral isolates via comparison and phylogenetic analysis by using the genetic information</description>
  </primary_outcome>
  <enrollment type="Actual">800</enrollment>
  <condition>Influenza</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood (serum) and nasopharyngeal swabs&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Paediatric or adult patients fulfilling the World Health Organization (WHO) definition of&#xD;
        an influenza-like illness. A total number of 1000 influenza PCR-confirmed cases should be&#xD;
        included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Each pediatric or adult patient, which fulfill the Worl Health Organization (WHO)&#xD;
             definition of Influenza like illness.&#xD;
&#xD;
          -  The case definition includes an acute respiratory infection with coughing, fever&#xD;
             ≥38°C, and start of symptoms within the last 10 days.&#xD;
&#xD;
          -  Presentation of the patient with influenza-like illness on the emergency ward of the&#xD;
             University Hospital Basel or the University Children Hospital of both Basel or a&#xD;
             collaborating private practise.&#xD;
&#xD;
          -  Patient has to live in the city of Basel.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not living in the City of Basel.&#xD;
&#xD;
          -  Case definition for influenza like illness is not fulfilled.&#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>Adrian Egli, PD Dr. FAMH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Microbiology, University Hospital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal Institute of Technology Zurich</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Children's Hospital</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätres Zentrum für Hausarztmedizin beider Basel, University of Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>High-Throughput Nucleotide Sequencing</keyword>
  <keyword>Viral Transmission</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03010007
org study id: Influenza in Basel 2016/2017
nct id: NCT03010007
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Influenza associated illness has a global annual impact with high morbidity and mortality.
      Transmission mechanisms and rates are under-investigated and overall poorly understood.

      This project aims to use epidemiological tools to understand the transmission and evolution
      of influenza viruses at an individual and population level within a small-scale city (Basel)
      through a combination of experimental, clinical and mathematical advances. The investigators
      aim to quantitatively characterize the viral transmission using novel
      molecular-epidemiological tools based on whole genome sequencing.
In this prospective observational study, paediatric and adult outpatients presenting with
      influenza-like illness will be enrolled at the emergency departments of the University
      Hospital Basel (USB), the paediatric University Hospital of both Basel (UKBB), or a network
      of family doctors (associated with Center of Primary Health Care).

      The Clinical Trial Unit at the University Hospital Basel will coordinated the recruitment
      process, collect data and sample all patients during the influenza season 2016/17. Samples
      will be collected such as whole blood, serum and DNA, nasopharyngeal swamps to diagnose
      influenza by polymerase chain reaction (PCR) assay and to determine colonization rates with
      Staphylococcus aureus and Streptococcus pneumonia. All samples except the first
      naso-pharyngeal swab for influenza diagnostics will be stored in a biobank and analysed in
      batches. Each influenza virus isolate will be sequenced using a "whole genome sequencing"
      approach. The viral transmission and evolution will be analysed using whole genome data for a
      detailed molecular and phylogenetic tree analysis, respectively. The epidemiological and
      geographical data will be incorporated into the phylogenetic model.

      Specific aims are:

      (i) to determine the impact of the most important epidemiological parameters, first focusing
      on the age profile, followed by children per house hold, and population density, on influenza
      transmission at an individual and population level, drawing on an analysis of baseline
      humoral immunity and whole genome sequencing data, (ii) to understand the viral evolution
      during seasonal epidemics, (iii) to develop dynamic mathematical models that are able to
      predict viral transmission and evolution based on the retrospective results from (i) and (ii)
      and to validate this model in future influenza seasons.

      To realize the interdisciplinary approach, the investigators will rely on the expertise in
      mathematical modelling of viral epidemiology and evolution and established geographical
      expertise, next generation sequencing, clinical epidemiology, and immunologic diagnostic
      techniques.
observational model: Ecologic or Community
time perspective: Prospective
measure: Investigation of the phylogenetic relation of viral isolates from participating patients using whole-genome sequencing and bioinformatics
time frame: Baseline
description: The primary microbiological endpoint is the connection of two viral isolates via comparison and phylogenetic analysis by using the genetic information
blood (serum) and nasopharyngeal swabs
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Adrian Egli, PD Dr. FAMH
role: Principal Investigator
affiliation: Clinical Microbiology, University Hospital Basel
facility: 
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No