Detection of GABHS in Throat Gargle

NCT ID: NCT03231098

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-12

Study Completion Date

2019-02-16

Brief Summary

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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

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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.

Conditions

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Group A Streptococcus: B Hemolytic Pharyngitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gargle Tech

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Avraham Alpert, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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TEREM Ha'Gdud Ha'Ivri Family Clinic

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type BACKGROUND
PMID: 15728991 (View on PubMed)

Other Identifiers

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STRP.P001

Identifier Type: -

Identifier Source: org_study_id