A Study to Expand Understanding of Coronavirus in U.S. Children (Enrolling by Invitation Only)

Overview

About this study

The purpose of this study is to evaluate the influenza vaccine effectiveness for preventing severe and life-threatening influenza-associated illness in children 6 months to 17 years of age.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - for VESIP:

  • Admission to PICU or SDU at any point during illness due to severity (not due to bed availability).
  • 8 months to 17 years old, inclusive.
  • Severe Acute Respiratory Infection:
    • > 1 sign of acute infection: fever or hypothermia (≥38°C or ≤5°C), WBC elevated or decreased for age, elevated CRP or procalcitonin, altered mental status); and
    • > 1 sign of acute respiratory illness: cough, shortness of breath, tachypnea or retractions, invasive or non-invasive mechanical ventilation, need for FiO2 to maintain SpO2 >92%, pulmonary infiltrate or hyperinflation on chest imaging.
  • Onset of symptoms < 10 days prior to enrollment.
  • Respiratory specimen for testing of influenza collected or performed within 72 hours of hospital admission.
  • At least 1 parent or legal guardian able and willing to provide permission.

Exclusion Criteria - for VESIP:

  • Previous enrollment in this study during the current season.
  • Chronic mechanical ventilator support through a tracheostomy for > 12 hours per day.
  • End stage lung disease awaiting transplant.
  • Evidence of current pregnancy from testing or other documentation.
  • > 72 hours since hospital presentation before enrollment, unless an upper respiratory sample that was collected ≤ 72 hours since hospital presentation (for clinical purposes) is available for testing for influenza status.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Emily Levy, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Emily Levy M.D.

(507) 255-8464

Levy.Emily@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20502644

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