DARWIN EU® - Characterising microbiological pathogen and antibiotic resistance data in DARWIN EU® Data Sources a priori mapped to the OMOP CDM

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Antimicrobial resistance (AMR) surveillance and microbiological pathogen data characterisation within DARWIN EU® real-world data sources mapped to OMOP CDM
• Study type:
  Non-interventional study
• Scope of the study:
  Feasibility analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

No information provided.

Study drug and medical condition

No information provided.

Population studied

No information provided.

Study design details

• Study design:
  Retrospective descriptive observational study
• Main study objective:
  1. To estimate the annual rate of recorded pre-selected bacterial pathogen episodes over time, overall and by age and sex.; 2. To characterise microbiological data associated with episodes of the pre-selected bacterial pathogens in terms of: ; a. The proportion of pathogen episodes with recorded Gram staining, microbiological culture, rapid antigen testing, molecular testing, phenotypic characteristics (e.g. haemolysis patterns, catalase, coagulase, oxidase, indole, urease, and motility), and antimicrobial susceptibility and resistance information, overall and by age and sex;; b. The characteristics associated with pathogen episodes, including age, sex, type of infection, and prior and post antibiotic use in relation to the pathogen episode index date.;
• Outcomes:
  The pre-selected bacterial pathogens, based on those included in the European Antimicrobial Resistance Surveillance Network (EARS-Net)[4], are Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter species, Streptococcus pneumoniae, Staphylococcus aureus, Enterococcus faecalis, and Enterococcus faecium. Pathogen identification will be based on relevant records across the OMOP CDM, including condition, observation, and microbiological records. Microbiological information associated with these pathogen episodes will be characterised separately. ; For Objective 2a, the frequency of recording of the following microbiological data related to the pre selected bacterial pathogens will be assessed: ; • Gram staining; ; • Microbiological culture; ; • Rapid antigen testing; ; • Molecular testing; ; • Phenotypic characteristics, including biochemical identification/profile, catalase, coagulase, oxidase, haemolysis, indole, urease, and motility, where available; and ; • Antibiogram or antimicrobial susceptibility/resistance result for an identified microorganism.