Clinical trial NCT01734668: Sofia RSV FIA Field Study
Official title: Sofia RSV FIA Field Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 2468
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment of RSV symptomatic pediatric subjects who are less than nineteen (19) years of age.

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.


Eligibility 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®.

Primary outcomes:
measure: High level of sensitivity and specificity for performance vs. culture
timeFrame: Culture results within 48 hours of plating
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Best Medical Group
state: Arizona
city: Panorama City
country: United States
facility: Santo Nino Medical Clinic
state: California
city: Boynton Beach
country: United States
facility: Genesis Community Health
state: Florida
city: Boynton Beach
country: United States
facility: Gentle Medical Associates
state: Florida
city: Delray Beach
country: United States
facility: Pediatrics by the Sea
state: Florida
city: Lake Worth
country: United States
facility: Soma Pediatrics
state: Florida
city: Miami
country: United States
facility: Adriana Castro
state: Florida
city: Pensacola
country: United States
facility: Lanza Pediatrics
state: Florida
city: St. Petersburg
country: United States
facility: Northeast Pediatrics
state: Florida
city: St. Petersburg
country: United States
facility: St. Petersburg Pediatrics
state: Florida
city: Tampa
country: United States
facility: Teena Hughes, MD
state: Florida
city: West Palm Beach
country: United States
facility: Soma Medical Center, PA Pediatric Site #3
state: Florida
city: West Palm Beach
country: United States
facility: Juan E. Batista, MD PA, Pediatric Site #2
state: Florida
city: Morris Plains
country: United States
facility: FastER Urgent Care
state: New Jersey
city: Rochester
country: United States
facility: Twelve Corners Pediatrics
state: New York
city: Belton
country: United States
facility: Veritas, PA
state: Texas
city: Vienna
country: United States
facility: Advanced Pediatrics
state: Virginia
Study officials:
affiliation: Quidel Corporation
name: John D Tamerius, PhD
role: STUDY_DIRECTOR
References: