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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 1, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

March 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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 ]
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[ Time Frame: 1 Week ]
Ease of use as assessed by operator questionnaire[ Time Frame: 1 Week ]

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Diagnostic

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Experimental: ellume·lab Group A Streptococcus Test
ellume·lab Group A Streptococcus Test

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

500

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 2019

Estimated Primary Completion Date

March 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

3 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Ellume Pty Ltd

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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