Sofia RSV FIA Field Study

Respiratory Syncytial Virus Clinical Trial

Official title:

Sofia RSV FIA Field Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734668
• Other study ID #: CS-0143-01
• Status: Completed
• Phase: N/A
• First received: November 20, 2012
• Last updated: February 5, 2013
• Start date: March 2012
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Quidel Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2468
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Respiratory Syncytial Virus

Intervention

Device:
• In Vitro Diagnostic device to aid in diagnosis

Locations

Country	Name	City	State
United States	Veritas, PA	Belton	Texas
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	FastER Urgent Care	Morris Plains	New Jersey
United States	Santo Nino Medical Clinic	Panorama City	California
United States	Lanza Pediatrics	Pensacola	Florida
United States	Best Medical Group	Phoenix	Arizona
United States	Twelve Corners Pediatrics	Rochester	New York
United States	Northeast Pediatrics	St. Petersburg	Florida
United States	St. Petersburg Pediatrics	St. Petersburg	Florida
United States	Teena Hughes, MD	Tampa	Florida
United States	Advanced Pediatrics	Vienna	Virginia
United States	Juan E. Batista, MD PA, Pediatric Site #2	West Palm Beach	Florida
United States	Soma Medical Center, PA Pediatric Site #3	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Quidel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No