Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03171350
Other study ID # E-GAS-AUS-1701
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2017
Est. completion date August 15, 2018

Study information

Verified date September 2018
Source Ellume Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
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 Completed
Enrollment 132
Est. completion date August 15, 2018
Est. primary completion date August 15, 2018
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;

- Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy

- = 5 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

- Participants who have pharyngitis with clinical features that suggest a viral etiology such as, cough, runny nose, upper respiratory symptoms, and/or oral ulcers

- 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

Study Design


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 patients. The sample type used is a throat swab.

Locations

Country Name City State
Australia Ochre Health Medical Centre Casey Australian Capital Territory
Australia Forbes Medical Centre Forbes New South Wales
Australia USC Clinical Trials Centre Maroochydore Queensland
Australia Paratus Clinical Wyong Clinic North Sydney New South Wales
Australia Griffith University Clinical Trial Unit Southport Queensland
Australia Mingara Medical Tumbi Umbi New South Wales
Australia Wamberal Surgery Wamberal New South Wales
Australia Paratus Clinical Wyoming Clinic Wyoming New South Wales

Sponsors (1)

Lead Sponsor Collaborator
Ellume Pty Ltd

Country where clinical trial is conducted

Australia, 

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 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 1 week
Primary The overall agreement between the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab and results from bacterial culture 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 1 week
Secondary The specificity of the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using throat swab as compared to PCR 1 week
Secondary The overall agreement between the ellume·lab Group A Strep Test in detecting Group A Streptococcus in samples collected using a throat swab and results from PCR 1 week
Secondary Ease of use as assessed by operator questionnaire. 1 week
See also
  Status Clinical Trial Phase
Withdrawn NCT03693495 - Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Participants With Acute Pharyngitis N/A
Recruiting NCT04882514 - A Trial of a Peptide-based Group A Streptococcal (GAS) Vaccine Candidate in Healthy Individuals. Phase 1/Phase 2
Completed NCT01979588 - How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice N/A
Completed NCT05117528 - Streptococcus Pyogenes Carriage Acquisition and Transmission Study
Completed NCT03361163 - Controlled Human Infection for Vaccination Against Streptococcus Pyogenes Phase 1
Completed NCT03777098 - Pilot Study of Strepic® Device for the Diagnosis of Group A Streptococcal Pharyngitis
Recruiting NCT05175196 - CandyCollect Strep Throat Testing N/A