<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/NCT02983019</url>
  </required_header>
  <id_info>
    <org_study_id>ISIM-LCR</org_study_id>
    <nct_id>NCT02983019</nct_id>
  </id_info>
  <brief_title>Treatment of Influenza in Routine Clinical Practice</brief_title>
  <acronym>FLU-EE</acronym>
  <official_title>Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nearmedic Plus LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nearmedic Plus LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the statistics of influenza and acute respiratory viral infections&#xD;
      (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology:&#xD;
      disease severity and bacterial exacerbations; patients demography; treatment duration and&#xD;
      timelines; safety; quality of treatment) in routine clinical practice with focus on drug&#xD;
      therapy and usage of interferons' inducers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This non-interventional study covers more than 15000 patients from outpatient sites in&#xD;
      Russia, Armenia, Moldova and Georgia.&#xD;
&#xD;
      Influenza and acute respiratory viral infections (ARVI) diagnosis validate according to&#xD;
      &quot;World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic&#xD;
      Influenza A (H1N1) 2009 and other Influenza Viruses&quot;. All patients' examinations are carried&#xD;
      out according to the local routine clinical practice and local and international standards of&#xD;
      care.&#xD;
&#xD;
      The following data will be collected and analyzed after the end of treatment:&#xD;
&#xD;
        -  demography&#xD;
&#xD;
        -  disease severity&#xD;
&#xD;
        -  body temperature&#xD;
&#xD;
        -  chills and fever (no/mild/severe)&#xD;
&#xD;
        -  weakness (no/mild/severe)&#xD;
&#xD;
        -  muscle or joint pain (no/mild/severe)&#xD;
&#xD;
        -  rhinitis (yes/no)&#xD;
&#xD;
        -  throat irritation (no/mild/severe)&#xD;
&#xD;
        -  headache (no/mild/severe)&#xD;
&#xD;
        -  cough (no/mild/severe)&#xD;
&#xD;
        -  conjunctivitis (no/mild/severe)&#xD;
&#xD;
        -  timelines: disease onset, first visit to physician, start of treatment&#xD;
&#xD;
        -  therapy (drug name, dose, with focus on interferons' inducers)&#xD;
&#xD;
        -  bacterial exacerbations (yes/no)&#xD;
&#xD;
        -  therapy of bacterial exacerbations (drug name)&#xD;
&#xD;
        -  adverse events&#xD;
&#xD;
        -  results of treatment satisfaction questionnaire for medication (TSQM-9), if completed by&#xD;
           patient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The socio-demographic data and symptoms of disease in the joint population of patients with influenza and influenza-like illness caused by different types of viruses</measure>
    <time_frame>up to 14 days</time_frame>
    <description>socio-demographic data, symptoms of disease</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The treatment description: names of drugs, dose, time of administration with regards to disease onset (&quot;early&quot; - from 1 to 3 days of symptoms; &quot;late&quot; - 4 or more days of symptoms)</measure>
    <time_frame>up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe)</measure>
    <time_frame>up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of influenza complications with antibacterial drugs administration requirement</measure>
    <time_frame>up to 14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion)</measure>
    <time_frame>up to 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient)</measure>
    <time_frame>up to 14 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">18946</enrollment>
  <condition>Influenza</condition>
  <condition>Acute Upper Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Therapy with interferons' inducers</arm_group_label>
    <description>Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapy without interferons' inducers</arm_group_label>
    <description>Therapy according to routine practice Groups will be splitted during the final data analysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kagocel</intervention_name>
    <description>Investigators could prescribe other drugs in frame of routine clinical practice</description>
    <arm_group_label>Therapy with interferons' inducers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with confirmed diagnosis of influenza or influenza-like illness caused by a&#xD;
        different type of virus which are on anti-flu therapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients ≥ 18 years old,&#xD;
&#xD;
          -  patients diagnosed with influenza or influenza-like illness caused by a different type&#xD;
             of virus,&#xD;
&#xD;
          -  patients to whom anti-flu treatment administered,&#xD;
&#xD;
          -  patients who have signed informed consent for management of their personal data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no exclusion criteria except participating in a current clinical trial because of&#xD;
             non-interventional sudy design&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ivan Sitnikov, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yaroslavl State Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yerevan State Medical University after M. Heratsi</name>
      <address>
        <city>Yerevan</city>
        <zip>0025</zip>
        <country>Armenia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University</name>
      <address>
        <city>T'bilisi</city>
        <zip>01059</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State University of Medicine and Pharmacy Nicolae Testemitanu</name>
      <address>
        <city>Kishinev</city>
        <country>Moldova, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kazan State Medical University</name>
      <address>
        <city>Kazan'</city>
        <zip>420012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Armenia</country>
    <country>Georgia</country>
    <country>Moldova, Republic of</country>
    <country>Russian Federation</country>
  </location_countries>
  <results_reference>
    <citation>Fazylov VK, Sitnikov IG, Silina EV, Shevchenko SB, Mozhina LN, Zamyatina LL, Yeganyan GA, Groppa LG, Korsantia BM. [Treatment for acute respiratory viral infection and influenza in daily clinical practice: Results of the multicenter international observational FLU-EE study]. Ter Arkh. 2016;88(11):68-75. doi: 10.17116/terarkh2016881168-75. Russian.</citation>
    <PMID>28005034</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>February 16, 2017</last_update_submitted>
  <last_update_submitted_qc>February 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>influenza</keyword>
  <keyword>flu</keyword>
  <keyword>acute respiratory viral infection</keyword>
  <keyword>ARVI</keyword>
  <keyword>acute upper respiratory infection</keyword>
  <keyword>AURI</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>
  <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/NCT02983019
org study id: ISIM-LCR
nct id: NCT02983019
lead sponsor: 
has dmc: No
This study evaluates the statistics of influenza and acute respiratory viral infections
      (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology:
      disease severity and bacterial exacerbations; patients demography; treatment duration and
      timelines; safety; quality of treatment) in routine clinical practice with focus on drug
      therapy and usage of interferons' inducers.
This non-interventional study covers more than 15000 patients from outpatient sites in
      Russia, Armenia, Moldova and Georgia.

      Influenza and acute respiratory viral infections (ARVI) diagnosis validate according to
      "World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic
      Influenza A (H1N1) 2009 and other Influenza Viruses". All patients' examinations are carried
      out according to the local routine clinical practice and local and international standards of
      care.

      The following data will be collected and analyzed after the end of treatment:

        -  demography

        -  disease severity

        -  body temperature

        -  chills and fever (no/mild/severe)

        -  weakness (no/mild/severe)

        -  muscle or joint pain (no/mild/severe)

        -  rhinitis (yes/no)

        -  throat irritation (no/mild/severe)

        -  headache (no/mild/severe)

        -  cough (no/mild/severe)

        -  conjunctivitis (no/mild/severe)

        -  timelines: disease onset, first visit to physician, start of treatment

        -  therapy (drug name, dose, with focus on interferons' inducers)

        -  bacterial exacerbations (yes/no)

        -  therapy of bacterial exacerbations (drug name)

        -  adverse events

        -  results of treatment satisfaction questionnaire for medication (TSQM-9), if completed by
           patient
observational model: Cohort
time perspective: Prospective
measure: The socio-demographic data and symptoms of disease in the joint population of patients with influenza and influenza-like illness caused by different types of viruses
time frame: up to 14 days
description: socio-demographic data, symptoms of disease
measure: The treatment description: names of drugs, dose, time of administration with regards to disease onset ("early" - from 1 to 3 days of symptoms; "late" - 4 or more days of symptoms)
time frame: up to 14 days
measure: The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe)
time frame: up to 14 days
measure: Frequency of influenza complications with antibacterial drugs administration requirement
time frame: up to 14 days
measure: Number of participants with treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion)
time frame: up to 14 days
measure: Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient)
time frame: up to 14 days
arm group label: Therapy with interferons' inducers
description: Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis
arm group label: Therapy without interferons' inducers
description: Therapy according to routine practice Groups will be splitted during the final data analysis
intervention type: Drug
intervention name: Kagocel
description: Investigators could prescribe other drugs in frame of routine clinical practice
arm group label: Therapy with interferons' inducers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Ivan Sitnikov, Professor
role: Principal Investigator
affiliation: Yaroslavl State Medical University
facility: 
facility: 
facility: 
facility: 
country: Armenia
country: Georgia
country: Moldova, Republic of
country: Russian Federation
citation: Fazylov VK, Sitnikov IG, Silina EV, Shevchenko SB, Mozhina LN, Zamyatina LL, Yeganyan GA, Groppa LG, Korsantia BM. [Treatment for acute respiratory viral infection and influenza in daily clinical practice: Results of the multicenter international observational FLU-EE study]. Ter Arkh. 2016;88(11):68-75. doi: 10.17116/terarkh2016881168-75. Russian.
PMID: 28005034
responsible party type: Sponsor
mesh term: Infections
mesh term: Influenza, Human
mesh term: Respiratory Tract Infections
sharing ipd: No