TerminatedNot Applicable

Sofia Strep A FIA Field Study

Stopped: Performance did not meet sponsor requirements.

United States2,090 participantsStarted 2011-11

Plain-language summary

The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.

Who can participate

Age range3 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presence of sore throat * Redness of the posterior pharyngeal wall * Tonsillar exudate * Tonsillar swelling * Tender anterior cervical adenopathy * Fever, \> 38º C (100.4ºF) at presentation or within past 24 hours Other symptoms that may be present, in addition to above symptoms for GAS: * Rash, typical of scarlet fever * Abnormal tympanic membranes * Palatal petechiae Exclusion Criteria: * Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study. * At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

Trial details

NCT IDNCT01494792

SponsorQuidel Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Group A Streptococcus trials