Back to resultsPerformance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
Primary Purpose
Group A Streptococcal Infection
Status
Withdrawn
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
ellume·lab Group A Streptococcus Test
Bacterial Culture
Polymerase Chain Reaction (PCR)
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 (or fossae);
- Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
- ≤ 14 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
- 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
- Prior enrollment in this clinical validation study
Sites / Locations
- Optimal Clinical Trials
- Totara Clinical Research Ltd
- Papamoa Pines Medical Centre
- Lakeland Clinical Trials
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 Pharyngeal samples from participants will be tested with: ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture.
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
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals
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
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
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
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals
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 PCR
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
Ease of use as assessed by operator questionnaire
The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03693495
Brief Title
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis
Official Title
A Prospective Multi-Centre Study of the Performance of 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
January 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study was cancelled before enrollment for reasons not related to safety and performance.
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
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
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
0 (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
Pharyngeal samples from participants will be tested with:
ellume.lab Group A Streptococcus Test; Polymerase Chain Reaction (PCR) and bacterial culture.
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 participants. The sample type used is a throat swab.
Intervention Type
Diagnostic Test
Intervention Name(s)
Bacterial Culture
Intervention Description
Pharyngeal swab is collected from participant and this specimen is inoculated into 5% sheep blood agar plates. Beta-haemolytic colonies are isolated, followed by latex agglutination test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Polymerase Chain Reaction (PCR)
Intervention Description
Polymerase Chain Reaction (PCR) is a molecular diagnostic technique for the detection and identification of Group A Streptococcus, both for clinical samples and isolates. Polymerase Chain Reaction (PCR) allows template bacterial RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
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
Description
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals
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
Description
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
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
Description
Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals
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 PCR
Description
Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
Time Frame
1 Week
Title
Ease of use as assessed by operator questionnaire
Description
The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).
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 (or fossae);
Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
≤ 14 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
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
Prior enrollment in this clinical validation study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barnaby H Montgomery
Organizational Affiliation
Optimal Clinical Trials
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optimal Clinical Trials
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Totara Clinical Research Ltd
City
New Lynn
State/Province
Auckland
ZIP/Postal Code
0600
Country
New Zealand
Facility Name
Papamoa Pines Medical Centre
City
Papamoa
State/Province
Tauranga
ZIP/Postal Code
3118
Country
New Zealand
Facility Name
Lakeland Clinical Trials
City
Rotorua
ZIP/Postal Code
3010
Country
New Zealand
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 Participants With Acute Pharyngitis
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