<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/NCT02972437</url>
  </required_header>
  <id_info>
    <org_study_id>naamap-HMO-CTIL</org_study_id>
    <nct_id>NCT02972437</nct_id>
  </id_info>
  <brief_title>Detection of Group A Streptococcus (GAS) in Oral Cavity</brief_title>
  <official_title>Detection of Group A Streptococcus (GAS) in Oral Cavity Using Molecular Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators intend to screen children who are suspected of having GAS tonsillitis. From&#xD;
      each child we will take a throat culture and saliva sample to screen for molecular evidence&#xD;
      of GAS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>molecular detection of GAS compared to throat culture detection</measure>
    <time_frame>3 days</time_frame>
    <description>3 days after taking the oral sample, the investigators will compare it to the throat culture taken at the same time.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Tonsillitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sample taking</intervention_name>
    <description>throat culture and oral cavity sample</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        children 3-16 years old with evidence of tonsilitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical evidence of GAS tonsillitis&#xD;
&#xD;
          -  healthy, no chronic illness&#xD;
&#xD;
          -  not a GAS carrier&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  GAS carrier&#xD;
&#xD;
          -  Active background disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>saar hashavya, doctor</last_name>
    <phone>972 53 223 3987</phone>
    <email>saarha@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>naama shwartz, doctor</last_name>
    <phone>972545216158</phone>
    <email>naamapines@gmail.com</email>
  </overall_contact_backup>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>November 27, 2016</last_update_submitted>
  <last_update_submitted_qc>November 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GAS in oral cavity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tonsillitis</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/NCT02972437
org study id: naamap-HMO-CTIL
nct id: NCT02972437
lead sponsor: 
has dmc: No
The investigators intend to screen children who are suspected of having GAS tonsillitis. From
      each child we will take a throat culture and saliva sample to screen for molecular evidence
      of GAS.
observational model: Cohort
time perspective: Prospective
measure: molecular detection of GAS compared to throat culture detection
time frame: 3 days
description: 3 days after taking the oral sample, the investigators will compare it to the throat culture taken at the same time.
intervention type: Other
intervention name: sample taking
description: throat culture and oral cavity sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 16 Years
healthy volunteers: No
last name: saar hashavya, doctor
phone: 972 53 223 3987
email: saarha@gmail.com
last name: naama shwartz, doctor
phone: 972545216158
email: naamapines@gmail.com
responsible party type: Sponsor
mesh term: Tonsillitis
sharing ipd: No