Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
- Conditions
- Group A Streptococcal Infection
- Interventions
- Diagnostic Test: ellume.lab Group A Streptococcus Test
- Registration Number
- NCT03171350
- Lead Sponsor
- Ellume Pty Ltd
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
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Male and female participants aged 3 years of age or older
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Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:
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Acute onset of sore throat;
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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;
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At least one of the following:
- Red and swollen/inflamed tonsils;
- Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
-
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≤ 5 days from onset of signs and symptoms of pharyngitis
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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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ellume.lab Group A Streptococcus Test ellume.lab Group A Streptococcus Test ellume.lab Group A Streptococcus Test
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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 throat swab as compared to PCR 1 week 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 Ease of use as assessed by operator questionnaire. 1 week
Trial Locations
- Locations (8)
Mingara Medical
🇦🇺Tumbi Umbi, New South Wales, Australia
Ochre Health Medical Centre
🇦🇺Casey, Australian Capital Territory, Australia
Forbes Medical Centre
🇦🇺Forbes, New South Wales, Australia
Paratus Clinical Wyong Clinic
🇦🇺North Sydney, New South Wales, Australia
Wamberal Surgery
🇦🇺Wamberal, New South Wales, Australia
USC Clinical Trials Centre
🇦🇺Maroochydore, Queensland, Australia
Paratus Clinical Wyoming Clinic
🇦🇺Wyoming, New South Wales, Australia
Griffith University Clinical Trial Unit
🇦🇺Southport, Queensland, Australia