Detection of Group A β-Hemolytic Streptococci in Oral Samples

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.

Study Overview

• Status: Recruiting
• Conditions: Group A β-Hemolytic Streptococci
• Intervention / Treatment: Other: Collection of oral and/or nasal samples

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Robert Levitz; Phone Number: +972.2.678.7342; Email: rlevitz@heroscientific.com
• Study Contact Backup: Name: Donna Ehrenberg; Email: donna.ehren@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Leumit Healthcare services
    • Contact: Ariel Yehuda; Email: aisrael@leumit.co.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population will be patients aged 3 years and older who are suspected of suffering from GABHS pharyngitis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Collection of oral and/or nasal samples; Collection of oral and/or nasal samples after SOC test performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Hero Scientific

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 18, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemolysis
• Other Study ID Numbers: STRP.P002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No