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

September 20, 2018 updated by: Ellume Pty Ltd

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Australian Capital Territory
      • Casey, Australian Capital Territory, Australia, 2913
        • Ochre Health Medical Centre
    • New South Wales
      • Forbes, New South Wales, Australia, 2871
        • Forbes Medical Centre
      • North Sydney, New South Wales, Australia, 2060
        • Paratus Clinical Wyong Clinic
      • Tumbi Umbi, New South Wales, Australia, 2261
        • Mingara Medical
      • Wamberal, New South Wales, Australia, 2260
        • Wamberal Surgery
      • Wyoming, New South Wales, Australia, 2250
        • Paratus Clinical Wyoming Clinic
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • USC Clinical Trials Centre
      • Southport, Queensland, Australia, 4215
        • Griffith University Clinical Trial Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ellume.lab Group A Streptococcus 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 1 week
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
Time Frame: 1 week
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
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 1 week
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
Time Frame: 1 week
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
Time Frame: 1 week
1 week
Ease of use as assessed by operator questionnaire.
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Glen Mulhall, University of the Sunshine Coast Clinical Trials Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2017

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

May 28, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 20, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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