Respiratory Syncytial VirusNCT01734668
Sofia RSV FIA Field Study
An observational study of Respiratory Syncytial Virus, run by Quidel Corporation at 17 sites in United States.
Trial summary
The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of age. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- In Vitro Diagnostic device to aid in diagnosis
- Type of treatment
- Medical device
- How many people
- 2,468 participants
- Where
- 17 sitesUnited States
- Study dates
- Mar 2012to Jan 2013
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Recruitment of RSV symptomatic pediatric subjects who are less than nineteen (19) years of age.
Who may be able to join
- Male or Female
- Children less than nineteen (19) years of age can participate (assuming appropriate consent is obtained).
- Must currently be exhibiting symptoms characteristic of respiratory syncytial virus (RSV) illness.
- Subjects must present with one or more of the following to be eligible for enrollment:
- Fever, ≥ 37.8º C (100º F) at present or within past 24 hours
- Moderate to severe runny nose*
Show all 14Show fewer
- Moderate to severe congestion*
- Decreased appetite
- Coughing
- Sneezing*
- Wheezing
- Irritability
- Decreased activity
- Labored breathing
Who cannot join
- Subjects nineteen years of age or older.
- The parent or legal guardian is unable to understand and consent to participation.
- Current or prior treatment during this infection with anti-RSV Synagis®.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Veritas, PA
Belton, Texas, 76513
Genesis Community Health
Boynton Beach, Florida, 33435
Gentle Medical Associates
Boynton Beach, Florida, 33435
Pediatrics by the Sea
Delray Beach, Florida, 33483
Soma Pediatrics
Lake Worth, Florida, 33460
Adriana Castro
Miami, Florida, 33173
FastER Urgent Care
Morris Plains, New Jersey, 07950
Santo Nino Medical Clinic
Panorama City, California, 91402
Lanza Pediatrics
Pensacola, Florida, 32504
Best Medical Group
Phoenix, Arizona, 85042
Twelve Corners Pediatrics
Rochester, New York, 14618
Northeast Pediatrics
St. Petersburg, Florida, 33702
St. Petersburg Pediatrics
St. Petersburg, Florida, 33710
Teena Hughes, MD
Tampa, Florida, 33613
Advanced Pediatrics
Vienna, Virginia, 22180
Soma Medical Center, PA Pediatric Site #3
West Palm Beach, Florida, 33406
Juan E. Batista, MD PA, Pediatric Site #2
West Palm Beach, Florida, 33415
About this study
The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of age.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- In Vitro Diagnostic device to aid in diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro Diagnostic device to aid in diagnosisDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
High level of sensitivity and specificity for performance vs. culture
Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.
Measured: Culture results within 48 hours of plating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusStudies 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
- 2,468 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
- NCT01734668
- Sponsor's protocol ID
- CS-0143-01
- Status last verified
- Feb 2013
- First submitted
- 20 Nov 2012
- 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
- Sofia RSV FIA Field Study
- ClinicalTrials.gov ID
- NCT01734668
- Acronym / sponsor ID
- CS-0143-01
- Conditions
- Respiratory Syncytial Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,468 participants (actual)
- Lead sponsor
- Quidel CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Nov 2012 (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 objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of age.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Recruitment of RSV symptomatic pediatric subjects who are less than nineteen (19) years of age.
Key inclusion criteria (14 listed)
- Male or Female
- Children less than nineteen (19) years of age can participate (assuming appropriate consent is obtained).
- Must currently be exhibiting symptoms characteristic of respiratory syncytial virus (RSV) illness.
- Subjects must present with one or more of the following to be eligible for enrollment:
Key exclusion criteria (3 listed)
- Subjects nineteen years of age or older.
- The parent or legal guardian is unable to understand and consent to participation.
- Current or prior treatment during this infection with anti-RSV Synagis®.
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 to aid in diagnosis | Device | – |
Primary outcome
High level of sensitivity and specificity for performance vs. culture
Time frame: Culture results within 48 hours of plating
Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.
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.
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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
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Syncytial Virus, run by Quidel Corporation at 17 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 14 inclusion and 3 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 17 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?
High level of sensitivity and specificity for performance vs. culture (time frame: Culture results within 48 hours of plating). 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.