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

Group A Streptococcal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03693495
• Other study ID #: E-GAS-NZ-1807
• Status: Withdrawn
• Phase: N/A
• Start date: September 2018
• Est. completion date: March 2019

Study information

• Verified date: January 2019
• Source: Ellume Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Group A Streptococcal Infection
• Pharyngitis
• Streptococcal Infections

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
New Zealand	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

Sponsors (1)

Lead Sponsor	Collaborator
Ellume Pty Ltd

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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