Sofia RSV FIA Field Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Quidel Corporation
ClinicalTrials.gov Identifier:
NCT01734668
First received: November 20, 2012
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Respiratory Syncytial Virus
Device: In Vitro Diagnostic device to aid in diagnosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Sofia RSV FIA Field Study

Further study details as provided by Quidel Corporation:

Primary Outcome Measures:
  • High level of sensitivity and specificity for performance vs. culture [ Time Frame: Culture results within 48 hours of plating ] [ Designated as safety issue: No ]
    Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.


Enrollment: 2468
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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®.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734668

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

No publications provided

Responsible Party: Quidel Corporation
ClinicalTrials.gov Identifier: NCT01734668     History of Changes
Other Study ID Numbers: CS-0143-01
Study First Received: November 20, 2012
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014