Detection of GABHS in Throat Gargle

Completed

• Conditions: Group A Streptococcus: B Hemolytic Pharyngitis

• Registration Number: NCT03231098
• Lead Sponsor: Gargle Tech

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-07-23
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Study Start: 2018-02-12
• Primary Completion: 2019-02-16
• Study Completion: 2019-02-16
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-08
• Last Update Posted: 2019-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quantitative: Average GABHS in gargle.	Through study completion, about 9 months	Average number of total GABHS bacteria collected in throat gargle samples.
Quantitative: Minimum GABHS in gargle.	Through study completion, about 9 months	Minimum number of total GABHS bacteria collected in throat gargle samples.

Trial Locations

Locations (1)

TEREM Ha'Gdud Ha'Ivri Family Clinic; 🇮🇱 Jerusalem, Israel