CompletedNCT03231098Updated Dec 10, 2019

Detection of GABHS in Throat Gargle

An observational study in Group A Streptococcus: B Hemolytic Pharyngitis, sponsored by Gargle Tech. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-10.

Sponsored by Gargle Tech · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 34
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Group A Streptococcus: B Hemolytic Pharyngitis

In context

Lead sponsor

This is the only study on the registry with Gargle Tech as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Observational model: Case-only
Time perspective: Prospective
Enrollment: 34 participants (actual)
Patient registry: No

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

TEREM Ha'Gdud Ha'Ivri Family Clinic
Jerusalem, 9234502, Israel

References and documents

Publications

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. PubMed 15728991 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Feb 2019, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 23, 2017
First posted: Jul 27, 2017
StartActual: Feb 12, 2018
Primary completionActual: Feb 16, 2019
CompletionActual: Feb 16, 2019
Last update: Dec 10, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03231098
Lead sponsor: Gargle Tech
Responsible party: Sponsor
First posted: Jul 27, 2017
Start date: Feb 12, 2018
Primary completion: Feb 16, 2019
Completion: Feb 16, 2019
Last update: Dec 10, 2019

Study contacts

Avraham Alpert, MD

principal investigator · Shaare Zedek Medical Center

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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