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
• Data collection methods:
  Secondary use of data

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

• Study design:
  Multi-center, retrospective identification of patients with positive cultures for carbapenemase- and MBL-producing Enterobacterales from surveillance rectal swabs and/or clinical samples.
• 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.
• Setting:
  ICU and hematology units in Spain.
• Outcomes:
  These variables measure the effect or consequence of the exposure in the study population:;  Prevalence of carbapenemase-producing Enterobacterales colonization: The proportion of patients with positive rectal swabs for CPE, either at admission or during their ICU/hematology stay, calculated by dividing the number of positive cases by the total number of patients screened within the analysis period.;  Prevalence of MBL-producing Enterobacterales colonization: The proportion of patients with positive rectal swabs for MBL-CPE, either at admission or during their ICU/hematology stay, calculated by dividing the number of positive cases by the total number of patients screened within the analysis period.;  Prevalence of MBL-producing Enterobacterales infection: The proportion of patients who have at least one clinical sample positive for MBL-producing Enterobacterales within 90 days following colonization (counting each unique positive culture), divided by the total number of patients colonized with MBL-producing ; Enterobacterales.;  Prevalence of MBL-producing Enterobacterales infection: This refers to the proportion of patients with at least one clinical sample testing positive for MBL producing Enterobacterales within 90 days after colonization (with each unique positive culture counted), divided by the total number of patients screened during the analysis period.;  Distribution of MBL types and resistance patterns: Analysis of resistance profiles, including susceptibility to aztreonam-avibactam, aztreonam, cefiderocol, ceftazidime-avibactam, meropenem, piperacillin-tazobactam, amikacin, colistin, and tigecycline.;  Comparison of prevalence between ICU and hematology patients: Stratified analysis of colonization/infection rates by unit type.
• 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.