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OpenTrials
Completed

NCT Number: NCT01734668

Sofia RSV FIA Field Study

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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Key information

Conditions

Respiratory Syncytial Virus

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Best Medical Group, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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®.

Treatment and study plan

In Vitro Diagnostic device to aid in diagnosis

Device

Primary outcomes

  1. High level of sensitivity and specificity for performance vs. culture

    Time frame: Culture results within 48 hours of plating

    Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.

Sponsors and collaborators

Lead sponsor

Quidel Corporation

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 28, 2012
Registry last updated
Feb 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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