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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.
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of oral and/or nasal samples | Other | Collection of oral and/or nasal samples after SOC test performed |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Study participation ( 1 day participation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Study participation ( 1 day participation) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be patients aged 3 years and older who are suspected of suffering from GABHS pharyngitis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Levitz | Contact | +972.2.678.7342 | rlevitz@heroscientific.com | |
| Donna Ehrenberg | Contact | donna.ehren@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leumit Healthcare services | Recruiting | Tel Aviv | Israel |
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