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

NCT03171350 | Completed

• 1 other identifier: E-GAS-AUS-1701
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Group A Streptococcal Infection

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• 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

• 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

• 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

• Ease of use as assessed by operator questionnaire.

  1 week

Study Arms (1)

ellume.lab Group A Streptococcus Test

EXPERIMENTAL

ellume.lab Group A Streptococcus Test

Diagnostic Test: ellume.lab Group A Streptococcus Test

Interventions

ellume.lab Group A Streptococcus Test 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.

ellume.lab Group A Streptococcus Test

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ellume Pty Ltd: lead

Study Sites (8)

Ochre Health Medical Centre

Casey, Australian Capital Territory, 2913, Australia

Location

Forbes Medical Centre

Forbes, New South Wales, 2871, Australia

Location

Paratus Clinical Wyong Clinic

North Sydney, New South Wales, 2060, Australia

Location

Mingara Medical

Tumbi Vmbi, New South Wales, 2261, Australia

Location

Wamberal Surgery

Wamberal, New South Wales, 2260, Australia

Location

Paratus Clinical Wyoming Clinic

Wyoming, New South Wales, 2250, Australia

Location

USC Clinical Trials Centre

Maroochydore, Queensland, 4558, Australia

Location

Griffith University Clinical Trial Unit

Southport, Queensland, 4215, Australia

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Glen Mulhall

  University of the Sunshine Coast Clinical Trials Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: May 31, 2017
• Study Start: May 24, 2017
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (8)