Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-28 @ 12:04 AM
Study NCT ID:
NCT05223634
Status:
UNKNOWN
Last Update Posted:
2022-02-04
First Post:
2022-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Group A β-Hemolytic Streptococci in Oral Samples
Sponsor:
Hero Scientific
Organization:
Study Overview
Official Title:
A Semi-Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Oral Samples
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: