A drug utilisation study (DUS) of the use of oral fidaxomicin in the routine clinical setting (2819-CL- 2002) (Anemone)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-authorisation, retrospective chart review

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FIDAXOMICIN
• Medical condition to be studied:
  Inflammatory bowel disease

  Clostridium difficile infection

  Renal impairment

  Hepatic function abnormal

  Pregnancy

Population studied

• Short description of the study population:
  Patients aged ≥ 18 years for whom the time of prescription of fidaxomicin and their entire corresponding observational period fell within the (country-specific) eligibility period.
• 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  512

Study design details

• Main study objective:
  The objective of this drug utilisation study is to furtherassess the use of fidaxomicin in standard clinicalpractice and to collect information on patient use in reallife conditions. Demographic and clinical data, includingmedical and treatment background, will be collected.
• Outcomes:
  To estimate the proportion of patients with a medical condition ofspecific interest (i.e. IBD, fulminant or life threatening CDI, moderate or severe hepatic impairment, renal impairment, pregnancy) of the total study population treated with fidaxomicin. To collect information of the use of fidaxomicin in routine clinical setting (indication, dose and duration of use) and to further assess safety characteristics (i.e. the events of death, and laboratory and electrocardiogram ECG results on specific timepoints) in patientspopulations with medical conditions of specific interest and in the overall population.
• Data analysis plan:
  All data for the subjects who meet the entry criteria will be summarized.Continuous variables will be summarized using descriptive statistics (mean, standard deviation, median, minimum, maximum), categorical variables will be summarized using frequency tabulationspresenting frequency and percentage (based on non-missing responses) in each category.