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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.
Enrollment
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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:
≤ 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
Primary purpose
Allocation
Interventional model
Masking
132 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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