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

Not Applicable

Withdrawn

• Conditions: Group A Streptococcal Infection
• Interventions: Diagnostic Test: ellume·lab Group A Streptococcus Test; Diagnostic Test: Bacterial Culture; Diagnostic Test: Polymerase Chain Reaction (PCR)

• Registration Number: NCT03693495
• Lead Sponsor: Ellume Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09
• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-16
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ellume·lab Group A Streptococcus Test	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.
ellume·lab Group A Streptococcus Test	Bacterial Culture	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.
ellume·lab Group A Streptococcus Test	Polymerase Chain Reaction (PCR)	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.

Primary Outcome Measures

Name	Time	Method
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	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	1 Week	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals

Secondary Outcome Measures

Name	Time	Method
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	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	1 Week	Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals
Ease of use as assessed by operator questionnaire	1 Week	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).

Trial Locations

Locations (4)

Papamoa Pines Medical Centre; 🇳🇿 Papamoa, Tauranga, New Zealand

Optimal Clinical Trials; 🇳🇿 Grafton, Auckland, New Zealand

Lakeland Clinical Trials; 🇳🇿 Rotorua, New Zealand

Totara Clinical Research Ltd; 🇳🇿 New Lynn, Auckland, New Zealand