A retrospective observational chart review study to evaluate the clinical effectiveness of treatment with zanamivir 10 mg/ml solution for infusion in a cohort of intensive care unit-treated (ICU) patients with complicated influenza infection (208165)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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:
  Cohort

Study drug and medical condition

• Medicinal product name:
  DECTOVA
• Study drug International non-proprietary name (INN) or common name:
  ZANAMIVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AH01) zanamivir

  zanamivir
• Medical condition to be studied:
  Influenza

  Death

Population studied

• Short description of the study population:
  Adults, adolescents, children and infants of all ages who were admitted to ICU with influenza illness.
• Age groups:
  • 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)
• Estimated number of subjects:
  1100

Study design details

• Main study objective:
  Among ICU-admitted patients with complicated influenza, all-cause in-hospital mortality will be compared between patients who received IVZ treatment with a propensity score matched group of patients who did not receive this therapy during the same influenza season and/or pandemic(s).
• Setting:
  Hospitals are eligible to participate in this study if they fulfil all of the following criteria:;  Tertiary centre with ICU ;  Ability to provide the variables of interest as described in Section 7.3.;  Ability for in-house testing for influenza type and sub-type by approved ; diagnostics.
• Comparators:
  ICU patients who did not receive this therapy during the same influenza seasons and/or pandemic(s).
• Outcomes:
  The primary efficacy variable is defined as the length of time between the index date and all-cause in-hospital mortality. Patients who do not experience all-cause in-hospital mortality will be censored at 28 days post treatment/matching or at loss to follow up. ; - All-cause in-hospital mortality up to end of follow-up (defined as 28 days post index date or at loss to follow-up) ; - All-cause in-hospital mortality at Day 7, 10 and 14 after treatment initiation/matching ; - Ordinal scale for clinical course of influenza disease at Day 7, 10 and 14 after treatment initiation/matching
• Data analysis plan:
  The primary analysis will consist of a matched cox regression model to estimate all-cause in-hospital mortality, presented as a hazard ratio for IV Zanamivir treatment vs matched control. ; A similar regression analysis will be performed to estimate in-hospital survival on day 7, 10 and 14 after treatment initiation/matching, and a proportional odds regression model will be fitted to analyse the ordinal scale date on the same days.