Detection of GABHS in Throat Gargle

Gargle Tech

Status: Completed

Conditions: Group A Streptococcus: B Hemolytic Pharyngitis

Study type: Observational

Funder types: Industry

Identifiers

NCT03231098

STRP.P001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.