Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.

Ellume

Status: Completed

Conditions: Group A Streptococcal Infection

Treatments: Diagnostic Test: ellume.lab Group A Streptococcus Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT03171350

E-GAS-AUS-1701

Details and patient eligibility

About

Participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. Enrolment visit (Day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab Group A Strep Test and testing for Group A Streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (PCR). All participants will be followed up with a phone assessment of adverse events between Days 2-14.

Enrollment: 132 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female participants aged 3 years of age or older

• Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:

  • Acute onset of sore throat;

  • Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and;

  • At least one of the following:

    • Red and swollen/inflamed tonsils;
    • Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy

• ≤ 5 days from onset of signs and symptoms of pharyngitis

• Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent

• Participants ≥18 years of age capable and willing to give informed consent

Exclusion criteria

• Participants < 3 years of age
• Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis
• Participants who have pharyngitis with clinical features that suggest a viral etiology such as, cough, runny nose, upper respiratory symptoms, and/or oral ulcers
• Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent
• Participants 18 years of age or older unable to understand English and consent to participation
• Parent/legal guardian of Participants < 18 years of age unable to understand English and consent to participation of child

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

ellume.lab Group A Streptococcus Test

Experimental group

Description:

ellume.lab Group A Streptococcus Test

Treatment:

Diagnostic Test: ellume.lab Group A Streptococcus Test