OZAVIE : Prospective observational study in patients treated with Zavicefta® (ceftazidime/avibactam) under real conditions of use

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Study drug and medical condition

• Name of medicine:
  ZAVICEFTA
• Medical condition to be studied:
  Infectious disease carrier

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  360

Study design details

• Main study objective:
  To describe the use of ZAVICEFTA® in hospitalised subjects suffering from infection in whom the decision has been taken to treat with ZAVICEFTA®, either alone or in combination.
• Outcomes:
  Measure effectiveness of ZAVICEFTA at EOT, at D30 after the start of treatment and D28 after EOT Assess the tolerability of ZAVICEFTA, in-hospital mortality and hospital readmissions, length of hospital and ICU stay Define characteristics of subjects and their comorbidities Describe sensitivity of pathogens to ZAVICEFTA, potential alternative therapies Explain reason for choosing ZAVICEFTA
• Data analysis plan:
  Appropriate statistical methods (mean values, standard deviations, median values, minimum and maximum values and 95% confidence intervals) will be used to describe the conditions of use for ZAVICEFTA®. In terms of the treatment tolerability assessment, the overall AE rate and rate of AE of specific interest will be expressed, together with their 95% confidence interval. The analysis will consist of a descriptive analysis of all of the variables collected from all of the subjects included in the study (Full Analysis Set – FAS).