Detection of GABHS in Throat Gargle

December 8, 2019 updated by: Gargle Tech

A Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Patient Throat Gargle

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 9234502
        • TEREM Ha'Gdud Ha'Ivri Family Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients age 18 years and older who present to the study site with complaints of sore throat and are suspected of suffering from GABHS pharyngitis.

Description

Inclusion Criteria:

  • Age 18 years or older.
  • Suspected of suffering from GABHS pharyngitis.
  • Able to communicate with study personnel (English or Hebrew).
  • Able to understand oral and written information about the study.
  • Willing to provide written informed consent to participate in the study.

Exclusion Criteria:

  • Not capable of gargling 10-15 mL fluid.
  • Diagnosed or self-reported pregnancy.
  • History of dementia, cognitive impairment, or psychiatric or mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparative: Method sensitivity to investigate method effectiveness.
Time Frame: Through study completion, about 9 months
Compare sensitivity of each gargle fluid GABHS detection method.
Through study completion, about 9 months
Comparative: Method specificity to investigate method effectiveness.
Time Frame: Through study completion, about 9 months
Compare specificity of each gargle fluid GABHS detection method.
Through study completion, about 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative: Average GABHS in gargle.
Time Frame: Through study completion, about 9 months
Average number of total GABHS bacteria collected in throat gargle samples.
Through study completion, about 9 months
Quantitative: Minimum GABHS in gargle.
Time Frame: Through study completion, about 9 months
Minimum number of total GABHS bacteria collected in throat gargle samples.
Through study completion, about 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gargle Tech

Investigators

  • Principal Investigator: Avraham Alpert, MD, Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 12, 2018

Primary Completion (ACTUAL)

February 16, 2019

Study Completion (ACTUAL)

February 16, 2019

Study Registration Dates

First Submitted

July 23, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (ACTUAL)

July 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2019

Last Update Submitted That Met QC Criteria

December 8, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRP.P001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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