Sofia RSV FIA Field Study
1 other identifier
observational
2,468
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Shorter than P25 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 20, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFebruary 7, 2013
February 1, 2013
10 months
November 20, 2012
February 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Culture results within 48 hours of plating
Interventions
Eligibility Criteria
Recruitment of RSV symptomatic pediatric subjects who are less than nineteen (19) years of age.
You may qualify if:
- 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\*
- Moderate to severe congestion\*
- Decreased appetite
- Coughing
- Sneezing\*
- Wheezing
- Irritability
- Decreased activity
- Labored breathing
You may not qualify if:
- 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®.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Best Medical Group
Phoenix, Arizona, 85042, United States
Santo Nino Medical Clinic
Panorama City, California, 91402, United States
Genesis Community Health
Boynton Beach, Florida, 33435, United States
Gentle Medical Associates
Boynton Beach, Florida, 33435, United States
Pediatrics by the Sea
Delray Beach, Florida, 33483, United States
Soma Pediatrics
Lake Worth, Florida, 33460, United States
Adriana Castro
Miami, Florida, 33173, United States
Lanza Pediatrics
Pensacola, Florida, 32504, United States
Northeast Pediatrics
St. Petersburg, Florida, 33702, United States
St. Petersburg Pediatrics
St. Petersburg, Florida, 33710, United States
Teena Hughes, MD
Tampa, Florida, 33613, United States
Soma Medical Center, PA Pediatric Site #3
West Palm Beach, Florida, 33406, United States
Juan E. Batista, MD PA, Pediatric Site #2
West Palm Beach, Florida, 33415, United States
FastER Urgent Care
Morris Plains, New Jersey, 07950, United States
Twelve Corners Pediatrics
Rochester, New York, 14618, United States
Veritas, PA
Belton, Texas, 76513, United States
Advanced Pediatrics
Vienna, Virginia, 22180, United States
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
John D Tamerius, PhD
Quidel Corporation
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2012
First Posted
November 28, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
February 7, 2013
Record last verified: 2013-02