Group A Streptococcus: B Hemolytic PharyngitisNCT03231098
Detection of GABHS in Throat Gargle
An observational study of Group A Streptococcus: B Hemolytic Pharyngitis, run by Gargle Tech at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Group A Streptococcus: B Hemolytic Pharyngitis
- How many people
- 34 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Feb 2018to 16 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not capable of gargling 10-15 mL fluid.
- Diagnosed or self-reported pregnancy.
- History of dementia, cognitive impairment, or psychiatric or mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Patient Throat Gargle
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative: Method sensitivity to investigate method effectiveness.
Compare sensitivity of each gargle fluid GABHS detection method.
Measured: Through study completion, about 9 months
Comparative: Method specificity to investigate method effectiveness.
Compare specificity of each gargle fluid GABHS detection method.
Measured: Through study completion, about 9 months
Secondary outcomes (2)
Quantitative: Average GABHS in gargle.
Average number of total GABHS bacteria collected in throat gargle samples.
Measured: Through study completion, about 9 months
Quantitative: Minimum GABHS in gargle.
Minimum number of total GABHS bacteria collected in throat gargle samples.
Measured: Through study completion, about 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start12 Feb 2018
- Primary completion16 Feb 2019
- Study completion16 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Group A Streptococcus: B Hemolytic PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gargle Tech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avraham Alpert, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231098
- Sponsor's protocol ID
- STRP.P001
- Status last verified
- Dec 2019
- First submitted
- 23 Jul 2017
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Patient Throat Gargle
- ClinicalTrials.gov ID
- NCT03231098
- Acronym / sponsor ID
- STRP.P001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Gargle TechIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 16 Feb 2019 (actual)
- Study completion
- 16 Feb 2019 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Not capable of gargling 10-15 mL fluid.
- Diagnosed or self-reported pregnancy.
- History of dementia, cognitive impairment, or psychiatric or mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparative: Method sensitivity to investigate method effectiveness.
Time frame: Through study completion, about 9 months
Compare sensitivity of each gargle fluid GABHS detection method.
Comparative: Method specificity to investigate method effectiveness.
Time frame: Through study completion, about 9 months
Compare specificity of each gargle fluid GABHS detection method.
2 secondary outcomes
Quantitative: Average GABHS in gargle.
Time frame: Through study completion, about 9 months
Quantitative: Minimum GABHS in gargle.
Time frame: Through study completion, about 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Background: PubMed 15728991Karabay 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avraham Alpert, MD principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group A Streptococcus: B Hemolytic Pharyngitis, run by Gargle Tech at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative: Method sensitivity to investigate method effectiveness. (time frame: Through study completion, about 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.