Detection of GABHS in Throat Gargle

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03231098

Enrollment

Registered

2017-07-27

Start date

2018-02-12

Completion date

2019-02-16

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Group A Streptococcus: B Hemolytic Pharyngitis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Israel

Outcome results