Clinical Trials

USIP Influenza LRTI (index participant)

Inclusion Criteria (must have all): 

• Admission to the hospital at any point during illness due to acute disease severity
• < 20 years old on hospital admission.
• Influenza associated LRTI:
  • Positive influenza test (rapid antigen, DFA or PCR); 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.
• At least 1 parent or legal guardian able and willing to provide permission.

Exclusion Criteria:

• Previous enrollment in this study during the current season.
• Hospital acquired influenza infection as determined by site hospital infection control experts.\

Influenza Negative Critically Ill Controls (Boston Children’s Hospital only)

Inclusion Criteria (must have all): 

• Admission to the intensive care unit.
• < 20 years old on hospital admission.
• Negative influenza test (rapid antigen, DFA, or PCR).
• Not suspected of having any infection and no clinical positive microbial testing.
• Intubated or tracheostomy and mechanically ventilated.
• At least 1 parent or legal guardian able and willing to provide permission.

Exclusion Criteria:

• Previous enrollment in this study during the current season.
• Immune compromised (primary or acquired) prior to admission or on steroids or other immune modulators in past 14 days.

Outpatient Noninfected Immune Competent Controls (Boston Children’s Hospital only)

Inclusion Criteria (must have all): 

• Outpatient.
• < 20 years old at time of outpatient visit.
• In usual state of health and no evidence of any infection.
• At least 1 parent or legal guardian able and willing to provide permission.

Exclusion Criteria:

• Previous enrollment in this study during the current season.
• Immune compromised (primary or acquired) prior to admission or on steroids or other immune modulators in past 14 days.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/3/22. Questions regarding updates should be directed to the study team contact.