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 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: * 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.

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.

Trial details

NCT IDNCT01494792

SponsorQuidel Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Group A Streptococcus trials

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.