Sofia RSV FIA Field Study

Completed

Conditions studied: Respiratory Syncytial Virus

In brief

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.

Key facts

Study ID

NCT01734668

Run by

Quidel Corporation

People needed

2468

Starts

2012-03-01

Expected to finish

2013-01-01

Last updated by the study team

2013-02-07

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

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®.

Where it is running

• Best Medical Group — Phoenix, Arizona, United States
• Santo Nino Medical Clinic — Panorama City, California, United States
• Genesis Community Health — Boynton Beach, Florida, United States
• Gentle Medical Associates — Boynton Beach, Florida, United States
• Pediatrics by the Sea — Delray Beach, Florida, United States
• Soma Pediatrics — Lake Worth, Florida, United States
• Adriana Castro — Miami, Florida, United States
• Lanza Pediatrics — Pensacola, Florida, United States
• Northeast Pediatrics — St. Petersburg, Florida, United States
• St. Petersburg Pediatrics — St. Petersburg, Florida, United States
• Teena Hughes, MD — Tampa, 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
• FastER Urgent Care — Morris Plains, New Jersey, United States
• Twelve Corners Pediatrics — Rochester, New York, United States
• Veritas, PA — Belton, Texas, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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