Detection of Group A β-Hemolytic Streptococci in Oral Samples

• Conditions: Group A β-Hemolytic Streptococci
• Interventions: Other: Collection of oral and/or nasal samples

• Registration Number: NCT05223634
• Lead Sponsor: Hero Scientific

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.)

Study Timeline

• Study Start: 2020-11-18
• Status Verified: 2022-01
• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-18
• Last Update Submitted: 2022-01-18
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Patient, either male or female, is age 3 years or older;
2. Patient is suspected of suffering from GABHS pharyngitis, and is prescribed a throat culture by conventional SOC;
3. Patient or legal guardian is able to communicate with study personnel;
4. 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.

Exclusion Criteria

1. 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)
2. pregnancy
3. Patients who took mouth rinse or taking oral treatment for mouth sores within 3 hours of study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oral and/or nasal specimen samples	Collection of oral and/or nasal 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

Primary Outcome Measures

Name	Time	Method
quantify and compare the amount of GABHS	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	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

Secondary Outcome Measures

Name	Time	Method
assess the efficacy of potential GABHS detection methods specifically designed for each oral and/or nasal sample type	Study participation ( 1 day participation)	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

Trial Locations

Locations (1)

Leumit Healthcare services; 🇮🇱 Tel Aviv, Israel