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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Comparative: Method sensitivity to investigate method effectiveness. | Compare sensitivity of each gargle fluid GABHS detection method. | Through study completion, about 9 months |
| Comparative: Method specificity to investigate method effectiveness. | Compare specificity of each gargle fluid GABHS detection method. | Through study completion, about 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative: Average GABHS in gargle. | Average number of total GABHS bacteria collected in throat gargle samples. | Through study completion, about 9 months |
| Quantitative: Minimum GABHS in gargle. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients age 18 years and older who present to the study site with complaints of sore throat and are suspected of suffering from GABHS pharyngitis.
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| Name | Affiliation | Role |
|---|---|---|
| Avraham Alpert, MD | Shaare Zedek Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TEREM Ha'Gdud Ha'Ivri Family Clinic | Jerusalem | 9234502 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15728991 | Background | 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. |
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Minimum number of total GABHS bacteria collected in throat gargle samples.
| Through study completion, about 9 months |