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

NCT03693495 | Withdrawn

• 1 other identifier: E-GAS-NZ-1807
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

• 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

• Ease of use as assessed by operator questionnaire

  1 Week

Study Arms (1)

ellume·lab Group A Streptococcus Test

EXPERIMENTAL

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; Diagnostic Test: Bacterial Culture; Diagnostic Test: Polymerase Chain Reaction (PCR)

Interventions

ellume·lab Group A Streptococcus Test 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.

ellume·lab Group A Streptococcus Test

Bacterial Culture 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.

ellume·lab Group A Streptococcus Test

Polymerase Chain Reaction (PCR) 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.

ellume·lab Group A Streptococcus Test

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ellume Pty Ltd: lead

Study Sites (4)

Optimal Clinical Trials

Grafton, Auckland, 1010, New Zealand

Location

Totara Clinical Research Ltd

New Lynn, Auckland, 0600, New Zealand

Location

Papamoa Pines Medical Centre

Papamoa, Tauranga, 3118, New Zealand

Location

Lakeland Clinical Trials

Rotorua, 3010, New Zealand

Location

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Barnaby H Montgomery

  Optimal Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (4)