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

NCT ID: NCT03693495

Last Updated: 2019-01-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• Study Completion Date: 2019-03-31

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.

Conditions

Group A Streptococcal Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ellume·lab Group A Streptococcus Test

Intervention Type: DIAGNOSTIC_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.

Bacterial Culture

Intervention Type: DIAGNOSTIC_TEST

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.

Polymerase Chain Reaction (PCR)

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ellume Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barnaby H Montgomery

Role: PRINCIPAL_INVESTIGATOR

Optimal Clinical Trials

Locations

Optimal Clinical Trials

Grafton, Auckland, New Zealand

Totara Clinical Research Ltd

New Lynn, Auckland, New Zealand

Papamoa Pines Medical Centre

Papamoa, Tauranga, New Zealand

Lakeland Clinical Trials

Rotorua, , New Zealand

Countries

New Zealand

Other Identifiers

E-GAS-NZ-1807

Identifier Type: -

Identifier Source: org_study_id