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CompletedNCT01734668Updated Feb 7, 2013

Sofia RSV FIA Field Study

An observational study in Respiratory Syncytial Virus, sponsored by Quidel Corporation. Completed at 17 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2013-02-07.

Sponsored by Quidel Corporation · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
2,468
Ages
Up to 18 Years
Sex
All
01

Study 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.

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Conditions studied

  • Respiratory Syncytial Virus
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In context

Lead sponsor

Quidel Corporation is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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®.
05

Study design

Time perspective
Prospective
Enrollment
2,468 participants (actual)
Patient registry
No

Interventions

  • DeviceIn Vitro Diagnostic device to aid in diagnosis
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Culture results within 48 hours of plating

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Study locations

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

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01734668
Lead sponsor
Quidel Corporation
Responsible party
Sponsor
First posted
Nov 28, 2012
Start date
Mar 2012
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Feb 7, 2013

Study contacts

John D Tamerius, PhD
study director · Quidel Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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