Anti-microbial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by MDR Gram-negative pathogens

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

  Systematic review and meta-analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01B) AMPHENICOLS

  AMPHENICOLS

Population studied

• Short description of the study population:
  Adult patients, 18 years or older, who had a confirmed multidrug-resistant (MDR) infection and received antimicrobial treatment.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1200000

Study design details

• Main study objective:
  Systematic review of all available treatment guidelines and recommendations and the evidence behind them, and a European cross-sectional six-country survey of antibiotic prescribing patterns and algorithms used in clinical practice. As added value, we will include an MDR treatment outcome analysis using existing Danish data and, if accessible, other European individual-level data.
• Data analysis plan:
  Systematic review of all available treatment guidelines and recommendations and the evidence behind them, and a European cross-sectional six-country survey of antibiotic prescribing patterns and algorithms used in clinical practice. As added value, we will include an MDR treatment outcome analysis using existing Danish data and, if accessible, other European individual-level data.

Documents

Study results

EMA MDR_final study report_revision_without track changes

Study publications

Nørgaard SM, Jensen CS, Aalestrup J, et al. Choice of therapeutic interventions…