Sofia RSV FIA Field 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.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus
• Intervention / Treatment: Device: In Vitro Diagnostic device to aid in diagnosis

• Study Type: Observational
• Enrollment (Actual): 2468

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85042
      • Best Medical Group
  • California
    • Panorama City, California, United States, 91402
      • Santo Nino Medical Clinic
  • Florida
    • Boynton Beach, Florida, United States, 33435
      • Gentle Medical Associates
    • Boynton Beach, Florida, United States, 33435
      • Genesis Community Health
    • Delray Beach, Florida, United States, 33483
      • Pediatrics by the Sea
    • Lake Worth, Florida, United States, 33460
      • Soma Pediatrics
    • Miami, Florida, United States, 33173
      • Adriana Castro
    • Pensacola, Florida, United States, 32504
      • Lanza Pediatrics
    • St. Petersburg, Florida, United States, 33702
      • Northeast Pediatrics
    • St. Petersburg, Florida, United States, 33710
      • St. Petersburg Pediatrics
    • Tampa, Florida, United States, 33613
      • Teena Hughes, MD
    • West Palm Beach, Florida, United States, 33406
      • Soma Medical Center, PA Pediatric Site #3
    • West Palm Beach, Florida, United States, 33415
      • Juan E. Batista, MD PA, Pediatric Site #2
  • New Jersey
    • Morris Plains, New Jersey, United States, 07950
      • FastER Urgent Care
  • New York
    • Rochester, New York, United States, 14618
      • Twelve Corners Pediatrics
  • Texas
    • Belton, Texas, United States, 76513
      • Veritas, PA
  • Virginia
    • Vienna, Virginia, United States, 22180
      • Advanced Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Recruitment of RSV symptomatic pediatric subjects who are less than nineteen (19) years of age.

Description

Inclusion Criteria:

1. Male or Female
2. Children less than nineteen (19) years of age can participate (assuming appropriate consent is obtained).
3. Must currently be exhibiting symptoms characteristic of respiratory syncytial virus (RSV) illness.

4. 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

Exclusion Criteria:

1. Subjects nineteen years of age or older.
2. The parent or legal guardian is unable to understand and consent to participation.
3. Current or prior treatment during this infection with anti-RSV Synagis®.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Quidel Corporation

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (ESTIMATE): November 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 5, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: CS-0143-01