Group A StreptococcusNCT02153008
Strep A FIA Field Study, Sofia
An observational study of Group A Streptococcus, run by Quidel Corporation at 7 sites in United States.
Trial summary
To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Group A Streptococcus
- How many people
- 1,708 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2014to 1 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be recruited from the general population as they present to the clinical facility. Subjects must be exhibiting symptoms characteristic of pharyngitis, possibly GAS.
Who may be able to join
- 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.
- For example:
- Acute onset of sore throat
- Redness of the posterior pharyngeal wall
- Difficulty/pain on swallowing
Show all 12Show fewer
- Fever, > 37.8º C (100ºF) at presentation or within past 24 hours
- Pharyngeal exudate
- Tender cervical lymphadenopathy
- Absence of cough, runny nose or other upper respiratory symptoms.*
- Other, symptoms specific to Strep A not listed above.
- Must include at least one additional symptom from a-f and cannot be the only criteria used to meet inclusion for enrollment in the study.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Veritas, PA
Belton, Texas, 76513
Gentle Medical Associates
Boynton Beach, Florida, 33435
Pediatrics by the Sea
Delray Beach, Florida, 33483
Best Medical Group, LLC
Phoenix, Arizona, 85042-6510
Twelve Corners Pediatrics
Rochester, New York, 14618
Teena Hughes, MD
Tampa, Florida, 33613
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
Official title: Sofia Strep A FIA Field Study
To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.
- Conditions
- Group A Streptococcus
- Keywords
- Strep throat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic population for GAS | This study is a diagnostic study to aid in the detection of Strep throat. No intervention or medication is a part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Group A Streptococcus
A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer
Measured: Within 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startApr 2014
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group A StreptococcusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quidel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John D. Tamerius, PhD, Study director, Quidel Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153008
- Sponsor's protocol ID
- CS-0142-07
- Status last verified
- Aug 2017
- First submitted
- 29 May 2014
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofia Strep A FIA Field Study
- ClinicalTrials.gov ID
- NCT02153008
- Acronym / sponsor ID
- CS-0142-07
- Conditions
- Group A Streptococcus
- Keywords
- Strep throat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,708 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the clinical performance of the Strep A FIA and Sofia, using throat swabs collected from symptomatic subjects.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic population for GAS | – | –This study is a diagnostic study to aid in the detection of Strep throat. No intervention or medication is a part of this study. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from the general population as they present to the clinical facility. Subjects must be exhibiting symptoms characteristic of pharyngitis, possibly GAS.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of Group A Streptococcus
Time frame: Within 5 minutes
A throat swab specimen will be obtained and tested for the presence of Group A Streptococcus via the Sofia Analyzer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. Tamerius, PhD study director
Quidel Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group A Streptococcus, run by Quidel Corporation at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Group A Streptococcus (time frame: Within 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.