Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A St… (NCT03171350) | Clinical Trial Compass
CompletedNot Applicable
Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.
Australia132 participantsStarted 2017-05-24
Plain-language 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.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 1 week
2
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
Timeframe: 1 week
3
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