Group A β-Hemolytic StreptococciNCT05223634
Detection of Group A β-Hemolytic Streptococci in Oral Samples
An observational study of Group A β-Hemolytic Streptococci, run by Hero Scientific at 1 site in Israel.
Trial summary
This prospective, sample collection study will assess different oral and/or nasal sample types collected from patients suspected of suffering from GABHS pharyngitis to conduct research and development on innovative GABHS detection methods specific for each sample type. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Group A β-Hemolytic Streptococci
- What is being tested?
- Collection of oral and/or nasal samples
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Nov 2020to Jun 2022
- 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 3 years and older
- All sexes
- Child, Adult, Older adult
Study population: The study population will be patients aged 3 years and older who are suspected of suffering from GABHS pharyngitis.
Who may be able to join
- Patient, either male or female, is age 3 years or older;
- Patient is suspected of suffering from GABHS pharyngitis, and is prescribed a throat culture by conventional SOC;
- Patient or legal guardian is able to communicate with study personnel;
- Patient or legal guardian is able to understand oral and written information regarding the nature of the study and is willing to provide written informed consent.
Who cannot join
- Patients presently on antibiotics prescribed by a physician for treatment or prevention of GAS infection or has taken antibiotics within the past 3 days ( unless patient only first started taking antibiotics within the past 24 hour)
- pregnancy
- Patients who took mouth rinse or taking oral treatment for mouth sores within 3 hours of study
Trial locations and contacts
1 site in 1 country.
Donna Ehrenberg contact
Israel1 site, 1 recruiting
- Recruiting
Leumit Healthcare services
Tel Aviv
Ariel Yehuda, aisrael@leumit.co.il
About this study
Official title: A Semi-Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Oral Samples
This prospective, sample collection study will assess different oral and/or nasal sample types collected from patients suspected of suffering from GABHS pharyngitis to conduct research and development on innovative GABHS detection methods specific for each sample type.
Read the detailed description
Study candidates are patients age 3 and older with complaints of sore throat and are suspected of suffering from GABHS pharyngitis. Patients who consent and are found eligible will be enrolled in the study. Subjects will be tested according to the conventional standard of care in addition to providing extra specimen samples for the study.
After each patient has been tested according to conventional SOC and has enrolled in the study, up to ten oral and/or nasal specimen samples will be collected . Study participation is complete once all specimen samples are collected.
Most or all collected samples will be qualitatively tested and may also be quantitatively and/or semi-quantitatively tested for the presence of GABHS. Some collected samples may additionally or alternatively be tested for other respiratory infections as well. (such as SARS-CoV-2, influenza, etc.)
- Conditions
- Group A β-Hemolytic Streptococci
- Being tested
- Collection of oral and/or nasal samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of oral and/or nasal samplesOther
Collection of oral and/or nasal samples after SOC test performed
| Study group | Role | What they receive |
|---|---|---|
| oral and/or nasal specimen samples | After each patient has been tested according to conventional SOC and has enrolled in the study, up to ten oral and/or nasal specimen samples will be collected Receives: Other: Collection of oral and/or nasal samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
quantify and compare the amount of GABHS
quantify the amount of GABHS contained in different oral and/or nasal sample types collected from patients who have been diagnosed with GABHS pharyngitis
Measured: Study participation ( 1 day participation)
compare the amount of GABHS in different oral and/or nasal samlpes
Compare the amount of GABHS contained in different oral and/or nasal sample types collected from patients who have been diagnosed with GABHS pharyngitis
Measured: Study participation ( 1 day participation)
Secondary outcomes (1)
assess the efficacy of potential GABHS detection methods specifically designed for each oral and/or nasal sample type
to assess the efficacy of potential GABHS detection methods specifically designed for each oral and/or nasal sample type by determining the sensitivity and specificity of each method in compare to the results from standard of care sampeling
Measured: Study participation ( 1 day participation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start18 Nov 2020
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group A β-Hemolytic StreptococciStudies 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
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hero Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223634
- Sponsor's protocol ID
- STRP.P002
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Semi-Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Oral Samples
- ClinicalTrials.gov ID
- NCT05223634
- Acronym / sponsor ID
- STRP.P002
- Conditions
- Group A β-Hemolytic Streptococci
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hero ScientificIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 4 Feb 2022 (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.
This prospective, sample collection study will assess different oral and/or nasal sample types collected from patients suspected of suffering from GABHS pharyngitis to conduct research and development on innovative GABHS detection methods specific for each sample type.
Detailed description
Study candidates are patients age 3 and older with complaints of sore throat and are suspected of suffering from GABHS pharyngitis. Patients who consent and are found eligible will be enrolled in the study. Subjects will be tested according to the conventional standard of care in addition to providing extra specimen samples for the study.
After each patient has been tested according to conventional SOC and has enrolled in the study, up to ten oral and/or nasal specimen samples will be collected . Study participation is complete once all specimen samples are collected.
Most or all collected samples will be qualitatively tested and may also be quantitatively and/or semi-quantitatively tested for the presence of GABHS. Some collected samples may additionally or alternatively be tested for other respiratory infections as well. (such as SARS-CoV-2, influenza, etc.)
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral and/or nasal specimen samples | – | Other: Collection of oral and/or nasal samplesAfter each patient has been tested according to conventional SOC and has enrolled in the study, up to ten oral and/or nasal specimen samples will be collected |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be patients aged 3 years and older who are suspected of suffering from GABHS pharyngitis.
Key inclusion criteria (4 listed)
- Patient, either male or female, is age 3 years or older;
- Patient is suspected of suffering from GABHS pharyngitis, and is prescribed a throat culture by conventional SOC;
- Patient or legal guardian is able to communicate with study personnel;
- Patient or legal guardian is able to understand oral and written information regarding the nature of the study and is willing to provide written informed consent.
Key exclusion criteria (3 listed)
- Patients presently on antibiotics prescribed by a physician for treatment or prevention of GAS infection or has taken antibiotics within the past 3 days ( unless patient only first started taking antibiotics within the past 24 hour)
- pregnancy
- Patients who took mouth rinse or taking oral treatment for mouth sores within 3 hours of study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of oral and/or nasal samplesCollection of oral and/or nasal samples after SOC test performed | Other | oral and/or nasal specimen samples |
Primary outcome
quantify and compare the amount of GABHS
Time frame: Study participation ( 1 day participation)
quantify the amount of GABHS contained in different oral and/or nasal sample types collected from patients who have been diagnosed with GABHS pharyngitis
compare the amount of GABHS in different oral and/or nasal samlpes
Time frame: Study participation ( 1 day participation)
Compare the amount of GABHS contained in different oral and/or nasal sample types collected from patients who have been diagnosed with GABHS pharyngitis
1 secondary outcome
assess the efficacy of potential GABHS detection methods specifically designed for each oral and/or nasal sample type
Time frame: Study participation ( 1 day participation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
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.
Donna Ehrenberg contact
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 β-Hemolytic Streptococci, run by Hero Scientific 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 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Levitz (+972.2.678.7342, rlevitz@heroscientific.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quantify and compare the amount of GABHS (time frame: Study participation ( 1 day participation)). 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?
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 4 Feb 2022.