Infectious Diseases Working Party (IDWP)
Study type:
Study number:
84140148
Type of Stem Cell Treatment:
Allogeneic
Diseases:
Complications: infectious
Short title:
Primary objective:
1) to describe the clinical, radiological and microbiological characteristics of Fusarium infections in allo-HCT patients;
2) to identify risk factors for Fusarium infections in allo-HCT patients, including antifungal prophylaxis.
Secondary objectives:
1) to assess the clinical outcome after Fusarium infection (all-cause mortality at 6 weeks);
2) to assess risk factors associated with mortality after Fusarium infection
3) to assess incidence of invasive fusariosis
2) to identify risk factors for Fusarium infections in allo-HCT patients, including antifungal prophylaxis.
Secondary objectives:
1) to assess the clinical outcome after Fusarium infection (all-cause mortality at 6 weeks);
2) to assess risk factors associated with mortality after Fusarium infection
3) to assess incidence of invasive fusariosis
Key inclusion criteria:
All allogeneic HSCT recipients who developed proven or probable Fusarium infection between 01 January 2010 and 31 May 2023 (irrespective of patient age, underlying disease or transplant date).
Country:
All EBMT member countries
Principal investigator:
Dina Averbuch
EBMT Study coordinator:
Lotus Wendel
Study coordinator email:
idwp@ebmt.org
EBMT Study Unit:
Leiden Study Unit
Reason for processing personal data:
Research and Development of new and improved transplant, cell therapy and immunosuppression procedures.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
3rd-party processors of Personal Data on behalf of EBMT/Service provider:
No
Privacy notices
Article 6 lawful basis for processing personal data:
Article 6.1 (a) - Consent (Collection)
Article 9 basis for processing special category data:
Article 9(2) (a) - Consent (Collection)
Data Protection Impact Assessments
Rights available to individuals:
Access
Data portability
Rectification
Objection
Deletion
Is a Data Protection Impact Assessment required?:
DPIA performed for EBMT Registry (WP & NIS Studies)
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results