<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/NCT01687816</url>
  </required_header>
  <id_info>
    <org_study_id>S53729</org_study_id>
    <nct_id>NCT01687816</nct_id>
  </id_info>
  <brief_title>Nasal Specimen Collection Study in Patients With ILI and/or ARI in an Outpatient Setting</brief_title>
  <official_title>Prospective, Nasal Specimen Collection Study in Patients Presenting With Influenza Like Illness and/or Acute Respiratory Infection in an Outpatient Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lieselot Houspie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective specimen collection study targeting patients presenting with Influenza&#xD;
      Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A&#xD;
      non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be&#xD;
      used. These nasal swabs will be collected in different volumes of viral transport media&#xD;
      (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected&#xD;
      biological specimen. The collection of nasal swabs samples will support the optimization of&#xD;
      point of care detection methods for respiratory viruses responsible for ILI and/or ARI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nasal swab collection of left and right nostril</measure>
    <time_frame>1 day</time_frame>
    <description>At the moment volunteer presents him/herself to the general practioner with influenza-like-illness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Completion of questionnaire</measure>
    <time_frame>1 day</time_frame>
    <description>Competion of a short questionnaire by the GP recording the clinical symptoms of the patient with ILI</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Influenza-like Illness</condition>
  <condition>Influenzal Acute Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>No interventions to be administered</arm_group_label>
    <description>Only a nasal swab is collected, no therapeutic interventions</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasal swabs of left and right nostril&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ILI will present with a sudden onset of symptoms and at least one of the&#xD;
        following four symptoms: fever or feverishness, malaise, headache, myalgia and at least one&#xD;
        of the following three respiratory symptoms: cough, sore throat, shortness of breath.&#xD;
&#xD;
        Patients with ARI will present with a sudden onset of symptoms and at least one of the&#xD;
        following four respiratory symptoms: cough, sore throat, shortness of breath, coryza and&#xD;
        the GP's judgment that the illness is due to an infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female&#xD;
&#xD;
          -  All Ages&#xD;
&#xD;
          -  Valid Informed Consent and/or Assent, where applicable&#xD;
&#xD;
          -  Onset of ILI and/or ARI within the last 3 days (≤ 72h)&#xD;
&#xD;
          -  Patient presented with ILI and/or ARI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Invalid Informed Consent and/or Assent&#xD;
&#xD;
          -  Onset of ILI and/or ARI was &gt; 3 days (&gt; 72 h)&#xD;
&#xD;
          -  Patient did not presented with neither ILI or ARI&#xD;
&#xD;
          -  Patient received intranasal attenuated influenza virus in last 3 weeks (example&#xD;
             FluMist®, Fluenz®)&#xD;
&#xD;
          -  Patient received treatment with influenza direct antivirals in the last 7 days&#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>Marc Van Ranst, M.D., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Leuven (KUL)</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Potter CW. A history of influenza. J Appl Microbiol. 2001 Oct;91(4):572-9. doi: 10.1046/j.1365-2672.2001.01492.x. No abstract available.</citation>
    <PMID>11576290</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 13, 2012</last_update_submitted>
  <last_update_submitted_qc>September 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>Lieselot Houspie</investigator_full_name>
    <investigator_title>PhD student Laboratory of Clinical Virology</investigator_title>
  </responsible_party>
  <keyword>Influenza-Like-Illness</keyword>
  <keyword>nasal swabs</keyword>
  <keyword>Detection of influenza</keyword>
  <keyword>sensitivity of detection assays</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT01687816
org study id: S53729
nct id: NCT01687816
lead sponsor: 
has dmc: Yes
This is a prospective specimen collection study targeting patients presenting with Influenza
      Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A
      non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be
      used. These nasal swabs will be collected in different volumes of viral transport media
      (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected
      biological specimen. The collection of nasal swabs samples will support the optimization of
      point of care detection methods for respiratory viruses responsible for ILI and/or ARI.
time perspective: Prospective
measure: Nasal swab collection of left and right nostril
time frame: 1 day
description: At the moment volunteer presents him/herself to the general practioner with influenza-like-illness
measure: Completion of questionnaire
time frame: 1 day
description: Competion of a short questionnaire by the GP recording the clinical symptoms of the patient with ILI
arm group label: No interventions to be administered
description: Only a nasal swab is collected, no therapeutic interventions
Nasal swabs of left and right nostril
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marc Van Ranst, M.D., PhD
role: Principal Investigator
affiliation: Rega Institute, Clinical Virology, Minderbroedersstraat 10, 3000 Leuven
facility: 
country: Belgium
citation: Potter CW. A history of influenza. J Appl Microbiol. 2001 Oct;91(4):572-9. doi: 10.1046/j.1365-2672.2001.01492.x. No abstract available.
PMID: 11576290
responsible party type: Sponsor-Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: Lieselot Houspie
investigator title: PhD student Laboratory of Clinical Virology
mesh term: Infections
mesh term: Influenza, Human
mesh term: Respiratory Tract Infections