<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/NCT03231098</url>
  </required_header>
  <id_info>
    <org_study_id>STRP.P001</org_study_id>
    <nct_id>NCT03231098</nct_id>
  </id_info>
  <brief_title>Detection of GABHS in Throat Gargle</brief_title>
  <official_title>A Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Patient Throat Gargle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gargle Tech</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gargle Tech</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to investigate the use of patient throat gargle as an&#xD;
      alternative to throat swabbing for the diagnosis of pharyngitis caused by Group A β-Hemolytic&#xD;
      Streptococcus (GABHS) infection, also known as strep throat.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to procure a detailed quantitative and qualitative analysis of GABHS&#xD;
      present in patient throat gargle and to compare various culturing techniques and immunoassay&#xD;
      methods for efficient and effective GABHS detection from gargle fluid. During the course of&#xD;
      this clinical trial, the following specimen samples will be collected from each participating&#xD;
      patient: the patient will first be asked to gargle 10-15 mL of sterile saline to obtain a&#xD;
      gargle sample, and then the patient will be subjected to two routine standard throat swabs.&#xD;
      These specimen samples will be properly discarded after processing and analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2018</start_date>
  <completion_date type="Actual">February 16, 2019</completion_date>
  <primary_completion_date type="Actual">February 16, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparative: Method sensitivity to investigate method effectiveness.</measure>
    <time_frame>Through study completion, about 9 months</time_frame>
    <description>Compare sensitivity of each gargle fluid GABHS detection method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparative: Method specificity to investigate method effectiveness.</measure>
    <time_frame>Through study completion, about 9 months</time_frame>
    <description>Compare specificity of each gargle fluid GABHS detection method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantitative: Average GABHS in gargle.</measure>
    <time_frame>Through study completion, about 9 months</time_frame>
    <description>Average number of total GABHS bacteria collected in throat gargle samples.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quantitative: Minimum GABHS in gargle.</measure>
    <time_frame>Through study completion, about 9 months</time_frame>
    <description>Minimum number of total GABHS bacteria collected in throat gargle samples.</description>
  </secondary_outcome>
  <enrollment type="Actual">34</enrollment>
  <condition>Group A Streptococcus: B Hemolytic Pharyngitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients age 18 years and older who present to the study site with complaints of sore&#xD;
        throat and are suspected of suffering from GABHS pharyngitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years or older.&#xD;
&#xD;
          -  Suspected of suffering from GABHS pharyngitis.&#xD;
&#xD;
          -  Able to communicate with study personnel (English or Hebrew).&#xD;
&#xD;
          -  Able to understand oral and written information about the study.&#xD;
&#xD;
          -  Willing to provide written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not capable of gargling 10-15 mL fluid.&#xD;
&#xD;
          -  Diagnosed or self-reported pregnancy.&#xD;
&#xD;
          -  History of dementia, cognitive impairment, or psychiatric or mental disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Avraham Alpert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaare Zedek Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TEREM Ha'Gdud Ha'Ivri Family Clinic</name>
      <address>
        <city>Jerusalem</city>
        <zip>9234502</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Karabay O, Ekerbicer H, Yilmaz F. Efficacy of throat gargling for detection of group a beta-hemolytic streptococcus. Jpn J Infect Dis. 2005 Feb;58(1):39-40.</citation>
    <PMID>15728991</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>December 8, 2019</last_update_submitted>
  <last_update_submitted_qc>December 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
    <mesh_term>Hemolysis</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/NCT03231098
org study id: STRP.P001
nct id: NCT03231098
lead sponsor: 
has dmc: Yes
The objective of this study is to investigate the use of patient throat gargle as an
      alternative to throat swabbing for the diagnosis of pharyngitis caused by Group A β-Hemolytic
      Streptococcus (GABHS) infection, also known as strep throat.
The aim of this study is to procure a detailed quantitative and qualitative analysis of GABHS
      present in patient throat gargle and to compare various culturing techniques and immunoassay
      methods for efficient and effective GABHS detection from gargle fluid. During the course of
      this clinical trial, the following specimen samples will be collected from each participating
      patient: the patient will first be asked to gargle 10-15 mL of sterile saline to obtain a
      gargle sample, and then the patient will be subjected to two routine standard throat swabs.
      These specimen samples will be properly discarded after processing and analysis.
observational model: Case-Only
time perspective: Prospective
measure: Comparative: Method sensitivity to investigate method effectiveness.
time frame: Through study completion, about 9 months
description: Compare sensitivity of each gargle fluid GABHS detection method.
measure: Comparative: Method specificity to investigate method effectiveness.
time frame: Through study completion, about 9 months
description: Compare specificity of each gargle fluid GABHS detection method.
measure: Quantitative: Average GABHS in gargle.
time frame: Through study completion, about 9 months
description: Average number of total GABHS bacteria collected in throat gargle samples.
measure: Quantitative: Minimum GABHS in gargle.
time frame: Through study completion, about 9 months
description: Minimum number of total GABHS bacteria collected in throat gargle samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Avraham Alpert, MD
role: Principal Investigator
affiliation: Shaare Zedek Medical Center
facility: 
country: Israel
citation: Karabay O, Ekerbicer H, Yilmaz F. Efficacy of throat gargling for detection of group a beta-hemolytic streptococcus. Jpn J Infect Dis. 2005 Feb;58(1):39-40.
PMID: 15728991
responsible party type: Sponsor
mesh term: Pharyngitis
mesh term: Hemolysis