Sofia RSV FIA Field Study

Completed

• Conditions: Respiratory Syncytial Virus

• Registration Number: NCT01734668
• Lead Sponsor: Quidel Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-28
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2468

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High level of sensitivity and specificity for performance vs. culture	Culture results within 48 hours of plating	Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.

Trial Locations

Locations (17)

Santo Nino Medical Clinic; 🇺🇸 Panorama City, California, United States

Adriana Castro; 🇺🇸 Miami, Florida, United States

Best Medical Group; 🇺🇸 Phoenix, Arizona, United States

Pediatrics by the Sea; 🇺🇸 Delray Beach, Florida, United States

Northeast Pediatrics; 🇺🇸 St. Petersburg, Florida, United States

St. Petersburg Pediatrics; 🇺🇸 St. Petersburg, Florida, United States

Soma Medical Center, PA Pediatric Site #3; 🇺🇸 West Palm Beach, Florida, United States

Juan E. Batista, MD PA, Pediatric Site #2; 🇺🇸 West Palm Beach, Florida, United States

Genesis Community Health; 🇺🇸 Boynton Beach, Florida, United States

Gentle Medical Associates; 🇺🇸 Boynton Beach, Florida, United States

Soma Pediatrics; 🇺🇸 Lake Worth, Florida, United States

Lanza Pediatrics; 🇺🇸 Pensacola, Florida, United States

Teena Hughes, MD; 🇺🇸 Tampa, Florida, United States

FastER Urgent Care; 🇺🇸 Morris Plains, New Jersey, United States

Veritas, PA; 🇺🇸 Belton, Texas, United States

Twelve Corners Pediatrics; 🇺🇸 Rochester, New York, United States

Advanced Pediatrics; 🇺🇸 Vienna, Virginia, United States