DARWIN EU® - Burden of meningococcal and gonococcal disease in the general population in European countries

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Gonorrhoea
• Additional medical condition(s):
  invasive meningococcal disease, IMD-related mortality

Population studied

• Short description of the study population:
  Objectives 1–3: Descriptive epidemiology of IMD, gonorrhoea, and mortality due to IMD; Inclusion criteria; • Present in the study period of 01/01/2017 until the end of available data in the selected data sources.; • Minimum 30 days of available history before index date.; Objective 4: Characterisation of individuals with IMD or gonorrhoea; Inclusion criteria; • At least one record of IMD or gonorrhoea during the study period (01/01/2017) until the end of available data in the selected data sources).; • Minimum 365 days of available history before index date (except for children <1 year during the study period).; Objective 5: Characterisation of meningococcal serogroup or carriage; Inclusion criteria; • At least one record of IMD or meningococcal carriage-related record during the study period (01/01/2017) until the end of available data in the selected data sources);
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 11 data sources from 10 countries across Europe and in 8 EU member states.
• Main study objective:
  1. To estimate incidence rates of IMD in the general population, overall and stratified by calendar year, sex, and age. ; 2. To estimate mortality rates due to IMD in the general population, overall and stratified by calendar year, sex, and age. ; 3. To estimate incidence rates of gonorrhoea in the general population, overall and stratified by calendar year, sex, and age. ; 4. To describe the demographic characteristics and clinical profile of individuals with IMD or gonorrhoea, including treatment with antibiotics. ;