Influenza Vaccine Effectiveness for Preventing Laboratory-Confirmed Severe Influenza-Associated Illness and Understanding Coronavirus Disease 2019
C
Courtney Rowan, MD
Primary Investigator
Enrolling By Invitation
8-17 years
All
Phase
N/A
400 participants needed
1 Location
Brief description of study
VESIP is an active observational, multicenter, prospective cohort study of children hospitalized in the US with severe acute respiratory illness (SARI). Enrollment criteria are designed to enrich the study population with patients infected with influenza or SARS-CoV-2 and admitted to an ICU or SDU (and for SARS-CoV-2 to the ward
Detailed description of study
1. Collection of a mid-turbinate nasal and/or oro-pharyngeal (OP) specimen (both when possible) and shipment to the central laboratory at VUMC. When this is not feasible, aliquots of the viral transport media from the clinical influenza or SARS-CoV-2 positive test sample may be substituted.
2. Interview with parent or legal guardian (and assenting child when relevant) to collect data about demographics, influenza and COVID-19 risk factors, receipt of influenza and BCG vaccinations, reasons for receiving or not receiving influenza vaccination, comorbidities, baseline functional status, acute presentation, history of healthcare utilization, medications and pre-hospital treatments including antivirals and other COVID-19 targeted therapies.
3. Medical record review for additional information on risk factors, comorbidities, and hospital course, including the following outcomes: hospital mortality, mechanical ventilation, organ failure and organ support, positive bacterial and other microbial cultures, length of PICU/SDU and hospital stay, and functional status at discharge.
4. Rigorous, standardized verification of influenza vaccination status.
5. Assessment of functional status assessment at baseline and at hospital discharge.
6. Assessment of functional status, respiratory symptoms and survival at 90 days post-enrollment in all patients enrolled in VESIP.
7. Assessment of readmissions, disease relapse and ongoing symptoms in COVID-19 patients at 14, 30 days and 60 days after enrollment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: SARI, Riley
-
Age: Between 8 Months - 17 Years
-
Gender: All
Inclusion Criteria:
- 1. Admission to PICU or SDU at any point during illness due to severity (not due to bed availability);
- 2. 8 months to 17 years old, inclusive;
- 3. Severe Acute Respiratory Infection:
- a. > 1 sign of acute infection: fever or hypothermia (≥38°C or ≤35°C), WBC elevated or decreased for age, elevated CRP or procalcitonin, altered mental status); and
- b. > 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;
- 4. Onset of symptoms < 10 days prior to enrollment;
- 5. Respiratory specimen for testing of influenza collected or performed within 72 hours of hospital admission;
Exclusion Criteria:
- revious enrollment in this study during the current season;
- 2. Chronic mechanical ventilator support through a tracheostomy for >12 hours per day;
- 3. End stage lung disease awaiting transplant;
- 4. Evidence of current pregnancy from testing or other documentation;
- 5. >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.
Updated on
13 Sep 2024.
Study ID: 2006182139, PICU-BCH-OVERCOMING-COVID
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