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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/47228
• EU PAS number:
  EUPAS7534
• Study ID:
  47228
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  This study will assess the incidence of invasive fungal diseases (IFDs) in patients with hematological malignancies (HMs, acute myeloid leukemia or acute lymphoid leukemia) admitted to Italian hematology wards. This study will also monitor the diagnostic and therapeutic management of suspected fungal-related febrile episodes in patients affected with HMs. Drug use in this study will be based on the investigators' daily clinical practice and data reported on the Summary of Product Characteristics.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Azienda Ospedaliero-Universitaria Di Parma Parma, Italy

Study timelines

Date when funding contract was signed

Actual: 05/07/2013

Study start date

Planned: 02/03/2015

Actual: 17/02/2015

Data analysis start date

Planned: 11/08/2016

Actual: 21/06/2016

Date of final study report

Planned: 16/06/2017

Actual: 08/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharpe & Dohme LLC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable