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

Study type

• Study topic:
  Disease /health condition

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

Study drug and medical condition

• Medicinal product name:
  EMBLAVEO
• Study drug International non-proprietary name (INN) or common name:
  AZTREONAM

  AVIBACTAM
• Anatomical Therapeutic Chemical (ATC) code:
  (J01DF51) aztreonam and beta-lactamase inhibitor

  aztreonam and beta-lactamase inhibitor

Population studied

• Short description of the study population:
  The study population includes critically ill adult patients admitted to ICU and hematology units in Spain.

Study design details

• Main study objective:
  To determine the prevalence of carbapenemase- and metallo-beta-lactamase-producing Enterobacterales rectal colonization at admission and during stays in the ICU and Hematology units in the analysis period. ; ; To determine the prevalence and distribution of MBL-producing Enterobacterales infections in critically ill adult patients admitted to ICU and Hematology units in the analysis period.
• Data analysis plan:
  The analyses of this study will be mainly descriptive, and as such, no statistical testing will be conducted. Descriptive statistics will be used to determine the prevalence of MBL-CPE colonization and infection, distribution of MBL types, patterns of co-resistance, and comparison of MBL-CPE prevalence between ICU and hematology units.