Retrospective Multi-center Study of the Burden of MBL-producing Enterobacterales in Critically Ill Adults in Spain

Study identification

• EU PAS number:
  EUPAS1000000733
• Study ID:
  1000000733
• Official title and acronym:
  Retrospective Multi-center Study of the Burden of MBL-producing Enterobacterales in Critically Ill Adults in Spain
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This secondary data collection study addresses the significant clinical burden posed by metallo-ß-lactamase (MBL)-producing Enterobacterales in critically ill adult patients. MBL-producing Enterobacterales are characterized by multidrug resistance and present substantial challenges in patient management. The study aims to determine the prevalence of MBL-producing Enterobacterales detected via rectal swabs and clinical specimens among patients in intensive care units (ICU) and hematological departments. The scientific basis for this investigation stems from the insufficient data concerning the relationship between colonization with MBL-producing Enterobacterales and the subsequent development of invasive infections in affected individuals.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

TFS HealthScience (TFS)

Sweden

Study timelines

Date when funding contract was signed

Planned:14/10/2025

Actual:14/10/2025

Study start date

Planned:29/05/2026

Data analysis start date

Planned:10/08/2026

Date of final study report

Planned:30/07/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

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