International documentation on the use of Cytotect CP® Biotest for patients after lung and heart transplantation (NIS-021 Cytotect)

Study type

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

  Effectiveness study (incl. comparative)

Population studied

• Short description of the study population:
  Male, female and diverse patients receiving CMV prophylaxis or treatment with Cytotect after Lung and Heart Transplantation at specialised transplant centres.
• Age groups:
  Adolescents (12 to < 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:
  500

Study design details

• Main study objective:
  Prospective documentation of the real-world usage of Cytotect for prophylaxis, pre-emptive treatment and treatment of CMV infection after heart transplantation (HT) and lung transplantation (LT).
• Outcomes:
  Primary outcome: Proportion of patients requiring treatment for CMV until month 12 after Cytotect prophylaxis start.; Secondary outcome: Proportion of patients developing CMV DNAemia until month 12 and 24 after Cytotect prophylaxis start.;
• Data analysis plan:
  All analyses will be performed in an exploratory sense. Since there are no confirmatory analyses planned, hypotheses are not formulated. Data will be analysed using descriptive statistics. For continuous variables, mean, standard deviation, minimum, maximum, median, 25% and 75% percentiles will be presented. Qualitative and categorical variables will be presented by means of absolute and relative frequencies. A statistical analysis plan will be prepared.