<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/NCT01733849</url>
  </required_header>
  <id_info>
    <org_study_id>116621</org_study_id>
    <nct_id>NCT01733849</nct_id>
  </id_info>
  <brief_title>A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children &lt; 5 Years of Age, in Bulgaria and Latvia</brief_title>
  <official_title>An Observational Study to Estimate the Disease Burden of Rotavirus Gastroenteritis in Infants/Children Less Than Five Years of Age in Primary Care Settings, in Bulgaria and Latvia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the&#xD;
      primary care settings of both Bulgaria and Latvia in children less than 5 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Primary care setting will include independent general practitioners (GP) (specialised in&#xD;
      paediatrics) or independent paediatricians.&#xD;
&#xD;
      Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested&#xD;
      immediately after collection. The stool sample will be stored for 24 hours only, in case the&#xD;
      test cannot be performed immediately after collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age.</measure>
    <time_frame>At the time of enrollment of each subject (Day 0).</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms related to AGE and their measures, stratified by rotavirus status for all the AGE cases reported by infants/children less than five years of age at the primary care settings.</measure>
    <time_frame>Day 0 - Day 14+5 (At the time of phone call follow-up contact).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.</measure>
    <time_frame>At the time of enrollment of each subject (Day 0).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospitalisations for RV GE and AGE, reported at the primary care settings.</measure>
    <time_frame>At the time of phone call follow-up contact (14 to 19 days after enrollment).</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1266</enrollment>
  <condition>Infections, Rotavirus</condition>
  <arm_group>
    <arm_group_label>Group Bulgaria</arm_group_label>
    <description>Subjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group Latvia</arm_group_label>
    <description>Subjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stool sample</intervention_name>
    <description>Samples will be tested to determine the presence or absence of rotavirus.</description>
    <arm_group_label>Group Bulgaria</arm_group_label>
    <arm_group_label>Group Latvia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Log books</description>
    <arm_group_label>Group Bulgaria</arm_group_label>
    <arm_group_label>Group Latvia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infants/children less than five years of age with home visits by the GP/paediatrician for&#xD;
        the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants/children with home visits by the GPGP/paediatrician for the treatment of AGE&#xD;
             or brought to the GP/paediatrician for AGE treatment during the study period.&#xD;
&#xD;
          -  A male or female infant/child less than five years of age at the time of the&#xD;
             GP/paediatrician visit. A child becomes ineligible on the day of her/his fifth&#xD;
             birthday.&#xD;
&#xD;
          -  Written informed consent obtained from the parents/legally acceptable representative&#xD;
             (LARs) of the subject.&#xD;
&#xD;
          -  Subjects who the investigator believes that his/her, parents/LARs can and will comply&#xD;
             with the requirements of the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Child in care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Burgas</city>
        <zip>8000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Burgas</city>
        <zip>8018</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dobrich</city>
        <zip>9300</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pazardzik</city>
        <zip>4400</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plovdiv</city>
        <zip>4000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ruse</city>
        <zip>7000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sliven</city>
        <zip>8800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1505</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1517</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1528</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Veliko Turnovo</city>
        <zip>5000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Balvi</city>
        <zip>LV-4501</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bauska</city>
        <zip>LV-3901</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Broceni</city>
        <zip>LV-3851</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Carnikava</city>
        <zip>LV-2163</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5401</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5410</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Druva</city>
        <zip>LV-3862</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Erglu pagasts</city>
        <zip>LV-4840</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Grobina</city>
        <zip>LV-3430</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ikskile</city>
        <zip>LV-5052</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jekabpils</city>
        <zip>LV-5201</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jelgava</city>
        <zip>LV-3001</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jelgava</city>
        <zip>LV-3002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jelgava</city>
        <zip>LV-3007</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jelgava</city>
        <zip>LV-3008</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kuldiga</city>
        <zip>LV-3300</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Liepaja</city>
        <zip>LV-3401</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Limbazi</city>
        <zip>LV-4001</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Livani</city>
        <zip>LV-5316</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madona</city>
        <zip>LV-4801</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ogre</city>
        <zip>LV-5001</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ozolnieki</city>
        <zip>LV-3018</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pinki</city>
        <zip>LV-2107</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rezekne</city>
        <zip>LV-4601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rezekne</city>
        <zip>LV-4604</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1001</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1010</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1011</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1012</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1024</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1050</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1063</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Riga</city>
        <zip>LV-1082</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ropazi</city>
        <zip>LV-2135</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sigulda</city>
        <zip>LV-2150</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tukums</city>
        <zip>LV-3101</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valmiera</city>
        <zip>LV-4200</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valmiera</city>
        <zip>LV-4201</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vangazi</city>
        <zip>LV-2136</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ventspils</city>
        <zip>LV-3601</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ventspils</city>
        <zip>LV-3602</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
    <country>Latvia</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bulgaria</keyword>
  <keyword>Primary care settings</keyword>
  <keyword>Children</keyword>
  <keyword>Latvia</keyword>
  <keyword>Acute gastroenteritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotavirus Infections</mesh_term>
    <mesh_term>Gastroenteritis</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/NCT01733849
org study id: 116621
nct id: NCT01733849
lead sponsor: 
This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the
      primary care settings of both Bulgaria and Latvia in children less than 5 years of age.
A Primary care setting will include independent general practitioners (GP) (specialised in
      paediatrics) or independent paediatricians.

      Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested
      immediately after collection. The stool sample will be stored for 24 hours only, in case the
      test cannot be performed immediately after collection.
observational model: Cohort
time perspective: Prospective
measure: Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age.
time frame: At the time of enrollment of each subject (Day 0).
measure: Symptoms related to AGE and their measures, stratified by rotavirus status for all the AGE cases reported by infants/children less than five years of age at the primary care settings.
time frame: Day 0 - Day 14+5 (At the time of phone call follow-up contact).
measure: Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.
time frame: At the time of enrollment of each subject (Day 0).
measure: Number of hospitalisations for RV GE and AGE, reported at the primary care settings.
time frame: At the time of phone call follow-up contact (14 to 19 days after enrollment).
arm group label: Group Bulgaria
description: Subjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
arm group label: Group Latvia
description: Subjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
intervention type: Other
intervention name: Stool sample
description: Samples will be tested to determine the presence or absence of rotavirus.
arm group label: Group Bulgaria
arm group label: Group Latvia
intervention type: Other
intervention name: Data collection
description: Log books
arm group label: Group Bulgaria
arm group label: Group Latvia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
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country: Bulgaria
country: Latvia
responsible party type: Sponsor
mesh term: Rotavirus Infections
mesh term: Gastroenteritis