Detection of GABHS in Throat Gargle

Group A Streptococcus: B Hemolytic Pharyngitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231098
• Other study ID #: STRP.P001
• Status: Completed
• Start date: February 12, 2018
• Est. completion date: February 16, 2019

Study information

• Verified date: December 2019
• Source: Gargle Tech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 16, 2019
• Est. primary completion date: February 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Group A Streptococcus: B Hemolytic Pharyngitis
• Hemolysis
• Pharyngitis

Locations

Country	Name	City	State
Israel	TEREM Ha'Gdud Ha'Ivri Family Clinic	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Gargle Tech

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparative: Method sensitivity to investigate method effectiveness.	Compare sensitivity of each gargle fluid GABHS detection method.	Through study completion, about 9 months
Primary	Comparative: Method specificity to investigate method effectiveness.	Compare specificity of each gargle fluid GABHS detection method.	Through study completion, about 9 months
Secondary	Quantitative: Average GABHS in gargle.	Average number of total GABHS bacteria collected in throat gargle samples.	Through study completion, about 9 months
Secondary	Quantitative: Minimum GABHS in gargle.	Minimum number of total GABHS bacteria collected in throat gargle samples.	Through study completion, about 9 months