CDC Pandemic Flu

Principal Investigator: Kwabena Ampofo
Keywords: CDC , flu , influenza , vaccine Department: Pediatric Administration
IRB Number: 00079644 Co Investigator:  
Specialty: Pediatric Infectious Diseases
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Sharada Dixit
sharada.dixit@hsc.utah.edu
8015877535

Brief Summary

OBJECTIVES

Epidemiology

  1. Describe the epidemiological and clinical characteristics and the clinical course, complications, and outcomes associated with patients hospitalized with pandemic influenza virus infection during all waves of the pandemic.
  1. Among patients hospitalized with pandemic influenza, describe factors associated with illness severity and specific outcomes.
  1. Among a subset of patients, describe the detection and duration of virus shedding during hospitalization.
  1. Among a subset of hospitalized patients, describe the degree and duration of protective antibody titers and other immune markers, and the frequency of markers of acute immune response against the pandemic virus.
  1. If resources permit, evaluate the association between host genomic variation and pandemic influenza-associated illness among patients who provide consent specifically for that purpose.

Antiviral Use, Effectiveness and Resistance

  1. Describe use of influenza antiviral drugs or therapies and predictors of antiviral use among patients hospitalized with pandemic influenza infection.
  1. Evaluate the effectiveness of treatment with antiviral agents to reduce illness duration and severity, and death among patients hospitalized with pandemic influenza virus infection, including the effect of antiviral dosing, duration, and timing (e.g., time from illness onset to treatment initiation).
  1. Among a subset of influenza-positive patients, describe the frequency of development of antiviral resistance during antiviral treatment and examine factors that may be associated with the development of resistance during treatment.
  1. Describe the frequency of adverse events for antiviral agents used in hospitalized populations for which there are limited data on drug adverse events.
  1. Evaluate cost-effectiveness of the use of antiviral agents for treatment.

Vaccine Effectiveness

  1. Evaluate the effectiveness of receipt of pandemic influenza vaccine against pandemic influenza hospitalization and its associated complications. If possible, we will stratify by age groups (children versus adults; or if possible, older adults), and by partial/fully vaccinated status, if indicated. If possible, we will evaluate the effect of prior seasonal influenza vaccination on the effectiveness of pandemic vaccines.
  1. Evaluate the effectiveness of receipt of current seasonal influenza vaccine against pandemic influenza hospitalization.
  1. Evaluate cost-effectiveness of pandemic influenza vaccines.

incidence

  1. Estimate the population-based incidence of laboratory-confirmed pandemic influenza-associated hospitalizations.

 

 

 

Inclusion Criteria

1.1.1       Inclusion and Exclusion Criteria

Inclusion criteria for patients 1 year of age and older: 1) hospitalized, and 2) at least two signs or symptoms from the list defined above within the last 7 days (time counting for onset date from the earliest sign/symptom reported as day zero) at time of screening/enrollment. Patients under observation in the ED or another location and not yet admitted are not eligible. To be eligible, patients must also have been admitted for fewer than 48 hours at the time of enrollment (with the exception of ICU/PICU patients requiring proxy where it can be extended to 72 hours, as noted above). For admitted patients transferred from other inpatient facilities, the patient’s time of admission at the original/transferring facility will be used to assess the 48 hour admission eligibility requirement.

Inclusion criteria for patients <1 year of age: 1) hospitalized, and 2) at least two signs or symptoms from the list defined above within the last 7 days (time counting for onset date from the earliest sign/symptom reported as day zero) at time of screening/enrollment, OR fever alone without another source.

 

Exclusion Criteria

Exclusion criteria: 1) Unable to sign informed consent or to identify a guardian or proxy o sign informed consent,

and 2) previously enrolled in the hospital study <14 days earlier;