Clinical trial NCT05223634: Detection of Group A β-Hemolytic Streptococci in Oral Samples
Official title: A Semi-Quantitative and Comparative Study for the Detection of Group A β-Hemolytic Streptococci in Oral Samples
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Group A β-Hemolytic Streptococci
Lead sponsor: Hero Scientific
Sponsor class: INDUSTRY
First posted: 2022-02-04
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
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.

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.)

Eligibility criteria: 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

Primary outcomes:
measure: quantify and compare the amount of GABHS
timeFrame: Study participation ( 1 day participation)
measure: compare the amount of GABHS in different oral and/or nasal samlpes
timeFrame: Study participation ( 1 day participation)
Secondary outcomes:
measure: assess the efficacy of potential GABHS detection methods specifically designed for each oral and/or nasal sample type
timeFrame: Study participation ( 1 day participation)
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Leumit Healthcare services
Study officials:
References: