Avian/Pandemic Influenza Registry (AVEX Registry)

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Medical condition to be studied:
  Avian influenza

Population studied

• Short description of the study population:
  All patients who developed influenza-like symptoms and who are considered to be epidemiologically linked by time, place, and exposure to a probable or confirmed avian influenza or human pandemic influenza case (in poultry, wild birds, animals or humans). In addition, patients with documented seroconversion (positive serological test in a national, regional or international influenza laboratory whose test results confirm infection with avian influenza), who either remain asymptomatic or experience only mild illness will be eligible for inclusion. All cases identified in the literature, by treating physicians and other health care providers or by local government or international agencies will be pursued for inclusion in the registry.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients infected with avian influenza A (H5N1)
• Estimated number of subjects:
  647

Study design details

• Main study objective:
  To better understand the clinical course of infection with H5N1, and the effectiveness of curently treatments used in humans
• Outcomes:
  survival, discharge from hospital with serious impairments
• Data analysis plan:
  Analyses are primarily descriptive. Relative risks are used to compare survival in patients receiving antivirals and other treatments compared to those who did not receive those treatments, and to understand the impact of various effect modifiers and potential confounders. Multivariate modeling may be used to examine the relationship between survival and a variety of clinical and epidemiologic factors. Multiple imputation may be used for important missing data.