Strep ThroatNCT01441479
Strep A Fluorescent Immunoassay and Analyzer Field Study
An observational study of Strep Throat, run by Quidel Corporation at 7 sites in United States.
Trial summary
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Strep Throat
- What is being tested?
- In Vitro Diagnostic Device aid in diagnosing
- Type of treatment
- Medical device
- How many people
- 1,282 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2011to Dec 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 greater than 3 years of age and exhibiting symptoms characteristic of pharyngitis, possibly Group A Streptococcus.
Who may be able to join
- Male and female subjects three (3) years of age or older
- Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis
- Extreme sore throat
- Redness of the posterior pharyngeal wall
- Difficulty Swallowing
- Fever, >38.7C (100F) at presentation or within past 24 hours
Show all 9Show fewer
- Pharyngeal exudate
- Tender cervical lymphadenopathy
- Absence of cough or other upper respiratory symptoms
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
La Costa Pediatrics
Carlsbad, California, 92009
FastER Urgent Care
Morris Plains, New Jersey, 07950
Best Medical Group
Phoenix, Arizona, 85042
Twelve Corners Pediatrics
Rochester, New York, 14618
La Jolla Pediatrics
San Diego, California, 92121
Teena Hughes
Tampa, Florida, 33613
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.
- Conditions
- Strep Throat
- Being tested
- In Vitro Diagnostic Device aid in diagnosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro Diagnostic Device aid in diagnosingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Streptococcus Group B identification
The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strep ThroatStudies 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
- 1,282 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
- NCT01441479
- Sponsor's protocol ID
- CS-0142-01
- Status last verified
- Dec 2012
- First submitted
- 23 Sep 2011
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strep A Fluorescent Immunoassay and Analyzer Field Study
- ClinicalTrials.gov ID
- NCT01441479
- Acronym / sponsor ID
- CS-0142-01
- Conditions
- Strep Throat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,282 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Sep 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 Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A 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 greater than 3 years of age and exhibiting symptoms characteristic of pharyngitis, possibly Group A Streptococcus.
Key inclusion criteria (9 listed)
- Male and female subjects three (3) years of age or older
- Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis
- Extreme sore throat
- Redness of the posterior pharyngeal wall
- Difficulty 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In Vitro Diagnostic Device aid in diagnosing | Device | – |
Primary outcome
Streptococcus Group B identification
Time frame: Immediate
The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.
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 7 Feb 2013.
Related trials for Strep Throat
Not yet recruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruitingPhase 1
Stopping Strep Throat With Antibodies in Healthy Adults.
Streptococcal Pharyngitis
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Not yet recruitingPhase 4
Short Versus Standard Amoxicillin for Pediatric Strep Throat
Group A Streptococcal (GAS) Pharyngitis
RecruitingObservational study
GRoup A StrePtococcus
Streptococcal Pharyngitis
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.
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 Strep Throat, 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 9 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 7 Feb 2013. 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?
Streptococcus Group B identification (time frame: Immediate). 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 7 Feb 2013.