CompletedNot Applicable

Strep A FIA Field Study, Sofia

United States1,708 participantsStarted 2014-04

Plain-language summary

To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.

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, 3 years of age or older
. Must currently be exhibiting one or more of the symptoms characteristic of pharyngitis to be eligible for inclusion in this study.
. Acute onset of sore throat
. Redness of the posterior pharyngeal wall
. Difficulty/pain on swallowing
. Fever, \> 37.8º C (100ºF) at presentation or within past 24 hours
. Pharyngeal exudate
. Tender cervical lymphadenopathy

Exclusion criteria

. Subjects currently under treatment with antibiotics 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.

What they're measuring

Detection of Group A Streptococcus

Timeframe: Within 5 minutes

Trial details

NCT IDNCT02153008

SponsorQuidel Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-07-01

View on ClinicalTrials.gov More Group A Streptococcus trials