Infectious Diseases Working Party (IDWP)
Study type:
Study number:
84140164
Type of treatment:
Allogeneic
Autologous
Diseases:
Complications: infectious
Short title:
CR-GN study
Primary objective:
To determine the incidence and predictors of GR-GN BSI caused by the colonising Carbapenem-resistant Gram-Negative (CR-GN) (i.e. risk factors associated with progression from colonization to BSI) or CR-GN which caused pre-HCT infection.
Key inclusion criteria:
- Having received allogeneic or autologous HCT between 01/01/2020 and 31/08/2025 which is fully registered in the EBMT registry
- Adults and children
- With documented Carbapenem Resistant-Gram Negative (CR-GN) colonisation within 3 months prior to HCT, or
- CR-GN infection within 3 months prior to HCT and resolved at the time of onset of conditioning
- Adults and children
- With documented Carbapenem Resistant-Gram Negative (CR-GN) colonisation within 3 months prior to HCT, or
- CR-GN infection within 3 months prior to HCT and resolved at the time of onset of conditioning
Country:
All EBMT member countries
Principal investigator:
Malgorzata Mikulska
EBMT Study coordinator:
Nina Knelange
EBMT Study Unit:
Leiden Study Unit
Reason for processing personal data:
Patients’ data is needed to be able to identify the patient and calculate age at any time (impact on SAEs and response to clinical medications). Health care personal data is part of the CV collected for evidence of proper qualification for running the trial.
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)
Centers’ contact / Centers’ policies
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