Back to resultsPerformance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
Primary Purpose
Group A Streptococcal Infection
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
ellume.lab Group A Streptococcus Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Group A Streptococcal Infection
Eligibility Criteria
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
Sites / Locations
- Ochre Health Medical Centre
- Forbes Medical Centre
- Paratus Clinical Wyong Clinic
- Mingara Medical
- Wamberal Surgery
- Paratus Clinical Wyoming Clinic
- USC Clinical Trials Centre
- Griffith University Clinical Trial Unit
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ellume.lab Group A Streptococcus Test
Arm Description
ellume.lab Group A Streptococcus Test
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
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
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
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
Ease of use as assessed by operator questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171350
Brief Title
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ellume Pty Ltd
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Group A Streptococcal Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ellume.lab Group A Streptococcus Test
Arm Type
Experimental
Arm Description
ellume.lab Group A Streptococcus Test
Intervention Type
Diagnostic Test
Intervention Name(s)
ellume.lab Group A Streptococcus Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Ease of use as assessed by operator questionnaire.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen Mulhall
Organizational Affiliation
University of the Sunshine Coast Clinical Trials Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochre Health Medical Centre
City
Casey
State/Province
Australian Capital Territory
ZIP/Postal Code
2913
Country
Australia
Facility Name
Forbes Medical Centre
City
Forbes
State/Province
New South Wales
ZIP/Postal Code
2871
Country
Australia
Facility Name
Paratus Clinical Wyong Clinic
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Mingara Medical
City
Tumbi Umbi
State/Province
New South Wales
ZIP/Postal Code
2261
Country
Australia
Facility Name
Wamberal Surgery
City
Wamberal
State/Province
New South Wales
ZIP/Postal Code
2260
Country
Australia
Facility Name
Paratus Clinical Wyoming Clinic
City
Wyoming
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
USC Clinical Trials Centre
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Griffith University Clinical Trial Unit
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
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