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

Group A Streptococcal Infection Clinical Trial

Official title:

A Prospective Multi-Centre Study of the Performance of the Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171350
• Other study ID #: E-GAS-AUS-1701
• Status: Completed
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: August 15, 2018

Study information

• Verified date: September 2018
• Source: Ellume Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Group A Streptococcal Infection
• Pharyngitis
• Streptococcal Infections

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Australia	Ochre Health Medical Centre	Casey	Australian Capital Territory
Australia	Forbes Medical Centre	Forbes	New South Wales
Australia	USC Clinical Trials Centre	Maroochydore	Queensland
Australia	Paratus Clinical Wyong Clinic	North Sydney	New South Wales
Australia	Griffith University Clinical Trial Unit	Southport	Queensland
Australia	Mingara Medical	Tumbi Umbi	New South Wales
Australia	Wamberal Surgery	Wamberal	New South Wales
Australia	Paratus Clinical Wyoming Clinic	Wyoming	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Ellume Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture		1 week
Primary	The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to bacterial culture		1 week
Primary	The overall agreement between the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab and results from bacterial culture		1 week
Secondary	The sensitivity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab as compared to PCR		1 week
Secondary	The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using throat swab as compared to PCR		1 week
Secondary	The overall agreement between the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab and results from PCR		1 week
Secondary	Ease of use as assessed by operator questionnaire.		1 week