A non-interventional, multicentre, prospective study to estimate the incidence of invasive fungal infections and to monitor the diagnostic and therapeutic management of suspected fungal-related febrile episodes in patients affected with hematological neoplasm (Hema e-Chart II) (MK-0991-803) (Hema E-Chart II)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational study, Review of electronic case report forms

Study drug and medical condition

• Medical condition to be studied:
  Fungal infection

  Acute myeloid leukaemia

  Acute lymphocytic leukaemia

Population studied

• Short description of the study population:
  Patients with hematological malignancies (HMs, acute myeloid leukemia or acute lymphoid leukemia) admitted to Italian hematology wards.
• 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:
  Other
• Special population of interest, other:
  Hematological malignancies patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To estimate the rate of occurrence of possible, probable, and proven IFDs in patients affected by newly diagnosed HMs (acute myeloid leukemia or acute lymphoid leukemia) admitted to hematology wards in Italy.
• Outcomes:
  Rate of occurrence of possible, probable, and proved IFDs.
• Data analysis plan:
  No formal statistical hypotheses will be tested, only descriptive statistics will be calculated. The analysis to assess the outcomes of patients with suspected fungal-related febrile events will be performed using standard survival analysis methods, including Kaplan-Meier product-limit survival curve estimates and log-rank tests for comparison between groups.

Documents

Study results

0991-803 ENCePP