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

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

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

• Status: Withdrawn
• Conditions: Group A Streptococcal Infection
• Intervention / Treatment: Diagnostic test: ellume·lab Group A Streptococcus Test; Diagnostic test: Bacterial Culture; Diagnostic test: Polymerase Chain Reaction (PCR)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Rotorua, New Zealand, 3010
    • Lakeland Clinical Trials
  • Auckland
    • Grafton, Auckland, New Zealand, 1010
      • Optimal Clinical Trials
    • New Lynn, Auckland, New Zealand, 0600
      • Totara Clinical Research Ltd
  • Tauranga
    • Papamoa, Tauranga, New Zealand, 3118
      • Papamoa Pines Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year 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 (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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ellume·lab Group A Streptococcus Test; 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.

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 participants. The sample type used is a throat swab.; Diagnostic test: Bacterial Culture; 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.; Diagnostic test: Polymerase Chain Reaction (PCR); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	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	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals	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	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals	1 Week

Secondary Outcome Measures

Outcome Measure	Measure Description	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	Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals	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 PCR	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals	1 Week
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).	1 Week

Collaborators and Investigators

• Sponsor: Ellume Pty Ltd
• Investigators: Principal Investigator: Barnaby H Montgomery, Optimal Clinical Trials

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Pharyngitis; Streptococcal Infections
• Other Study ID Numbers: E-GAS-NZ-1807

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