Group A StreptococcusNCT01494792
Sofia Strep A FIA Field Study
An observational study of Group A Streptococcus and Strep Throat, run by Quidel Corporation at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Group A Streptococcus, Strep Throat
- What is being tested?
- In Vitro Diagnositc aid for diagnosis
- Type of treatment
- Medical device
- How many people
- 2,090 participants
- Where
- 8 sitesUnited States
- Study dates
- Nov 2011to Aug 2012
- 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 must be three (3) years of age or older and exhibiting symptoms characteristics of pharyngitis, possibly Group A Streptococcus.
Who may be able to join
- 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
Show all 10Show fewer
- Other symptoms that may be present, in addition to above symptoms for GAS:
- Rash, typical of scarlet fever
- Abnormal tympanic membranes
- Palatal petechiae
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Montrose Family Practice
Akron, Ohio, 44333
La Costa Pediatrics
Carlsbad, California, 92009
Children's Memorial Hospital
Chicago, Illinois, 60614-3394
Santo Nino Medical Clinic
Panorama City, California, 91402
Twelve Corners Pediatrics
Rochester, New York, 14618
La Jolla Pediatrics
San Diego, California, 92121
Teena Hughes, MD
Tampa, Florida, 33613
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
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.
- Conditions
- Group A Streptococcus, Strep Throat
- Being tested
- In Vitro Diagnositc aid for diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro Diagnositc aid for diagnosisDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Performance did not meet sponsor requirements.
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
- Time perspective
- Prospective
- Enrolment
- 2,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quidel Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494792
- Sponsor's protocol ID
- CS-0142-02
- Status last verified
- Oct 2012
- First submitted
- 15 Dec 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofia Strep A FIA Field Study
- ClinicalTrials.gov ID
- NCT01494792
- Acronym / sponsor ID
- CS-0142-02
- Conditions
- Group A Streptococcus, Strep Throat
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Performance did not meet sponsor requirements.
- Enrolment
- 2,090 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Dec 2011 (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.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects must be three (3) years of age or older and exhibiting symptoms characteristics of pharyngitis, possibly Group A Streptococcus.
Key inclusion criteria (10 listed)
- Presence of sore throat
- Redness of the posterior pharyngeal wall
- Tonsillar exudate
- Tonsillar swelling
- Tender anterior cervical adenopathy
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In Vitro Diagnositc aid for diagnosis | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Performance did not meet sponsor requirements.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 and Strep Throat, run by Quidel Corporation at 8 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 10 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: stopped early, as of the sponsor's last update on 10 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 was stopped early (reason given: Performance did not meet sponsor requirements.). Results are not available in the source record.
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.
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 10 Oct 2012.