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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-24

Study Completion Date

2018-08-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Group A Streptococcal Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ellume.lab Group A Streptococcus Test

Group Type EXPERIMENTAL

ellume.lab Group A Streptococcus Test

Intervention Type DIAGNOSTIC_TEST

ellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic patients. The sample type used is a throat swab.

Interventions

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ellume.lab Group A Streptococcus Test

ellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic patients. The sample type used is a throat swab.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No