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Completed

NCT Number: NCT03231098

Detection of GABHS in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

TEREM Ha'Gdud Ha'Ivri Family Clinic

Jerusalem, 9234502, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Comparative: Method sensitivity to investigate method effectiveness.

    Time frame: Through study completion, about 9 months

    Compare sensitivity of each gargle fluid GABHS detection method.

  2. Comparative: Method specificity to investigate method effectiveness.

    Time frame: Through study completion, about 9 months

    Compare specificity of each gargle fluid GABHS detection method.

Secondary outcomes

  1. Quantitative: Average GABHS in gargle.

    Time frame: Through study completion, about 9 months

    Average number of total GABHS bacteria collected in throat gargle samples.

  2. Quantitative: Minimum GABHS in gargle.

    Time frame: Through study completion, about 9 months

    Minimum number of total GABHS bacteria collected in throat gargle samples.

Sponsors and collaborators

Lead sponsor

Gargle Tech

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2017
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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