<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/NCT01704222</url>
  </required_header>
  <id_info>
    <org_study_id>I07040 CrèchMV</org_study_id>
    <nct_id>NCT01704222</nct_id>
  </id_info>
  <brief_title>Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France</brief_title>
  <acronym>CrèchMV</acronym>
  <official_title>Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Limoges</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Direct DNA amplification, viral isolation and specific antibody measurement in saliva from&#xD;
      children attending nursery in France Sample collection will be done by the pediatrician the&#xD;
      nurse, or one of the authorized investigators of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Salivary collection kit. 3 swab for DNA research, 1 for antibodies research and 1 for virus&#xD;
      isolation by cell growth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Identification of viral shedding</measure>
    <time_frame>1 day</time_frame>
    <description>Saliva using small sponges, non-invasive for the viral genome, isolating virus strains and measurement of antibody IgG and IgA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the distribution of different genotypes of strains of CMV</measure>
    <time_frame>1 day</time_frame>
    <description>distribution by genotype strains found</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2001</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Child in nursery</arm_group_label>
    <description>Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Direct DNA amplification, viral isolation and specific antibody measurement in saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children older than 3 months and less than 6 years kept in nurseries retained, regardless&#xD;
        of the duration of custody of the child in the manger concerned.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children older than 3 months and less than 6 years kept in nurseries retained,&#xD;
             regardless of the duration of custody of the child in the manger concerned.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of parents (lack of consent)&#xD;
&#xD;
          -  Refusal of the child according to his ability to understand&#xD;
&#xD;
          -  Uninsured social security&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophie ALAIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Limoges UH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bacteriology</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>October 31, 2013</last_update_submitted>
  <last_update_submitted_qc>October 31, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>nursery</keyword>
  <keyword>CMV</keyword>
  <keyword>Infection</keyword>
  <!-- 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/NCT01704222
org study id: I07040 CrèchMV
nct id: NCT01704222
lead sponsor: 
has dmc: No
Direct DNA amplification, viral isolation and specific antibody measurement in saliva from
      children attending nursery in France Sample collection will be done by the pediatrician the
      nurse, or one of the authorized investigators of the study.
Salivary collection kit. 3 swab for DNA research, 1 for antibodies research and 1 for virus
      isolation by cell growth.
observational model: Cohort
time perspective: Prospective
measure: Identification of viral shedding
time frame: 1 day
description: Saliva using small sponges, non-invasive for the viral genome, isolating virus strains and measurement of antibody IgG and IgA.
measure: Evaluate the distribution of different genotypes of strains of CMV
time frame: 1 day
description: distribution by genotype strains found
arm group label: Child in nursery
description: Children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned.
Direct DNA amplification, viral isolation and specific antibody measurement in saliva
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sophie ALAIN, MD
role: Principal Investigator
affiliation: Limoges UH
facility: 
country: France
responsible party type: Sponsor