A description of the management of invasive fungal infections with oral posaconazole maintenance treatment following intravenous antifungal regimens in routine UK clinical practice (MAINTAIN)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  POSACONAZOLE
• Medical condition to be studied:
  Fungal infection

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:
  30

Study design details

• Main study objective:
  To describe the population of patients who receive oral posaconazole following previous intravenous (IV) antifungal treatment for possible, probable or proven invasive fungal infection.
• Outcomes:
  Demographic/disease characteristics including, Gender, age, ethnicity, weight, height and BMI, Comorbidities, primary diagnosis inc transplant type if relevant, Graft vs host disease (GVHD) prophylaxis, treatment of acute GVHD if relevant, prior and current chemotherapy regimens, reasons for initiating initial IV antifungal agent, probable/possible/proven IFI, type of fungal infection. Antifungal prophylaxis regimens prior to starting IFI treatment, IV antifungal regimens prior to posaconazole initiation, posaconazole dose & duration, outcomes at 12 months post-initiation of IV antifungal treatment (% patients with resolution of infection according to CT, % surviving, % with no further IV antifungal treatment), resource use (tests & hospital attendances) during IFI treatment
• Data analysis plan:
  Analyses will be descriptive in nature. Both distributions and descriptive statistics of both central tendency (medians and arithmetic or geometric means) and dispersion (standard deviation, interquartile range) will be presented for quantitative variables. Nominal variables will be described with frequencies, percentages and modes, while ordinal variables will also have medians and interquartile ranges described.