The risk of acute liver injury with the use of antibiotics. A replication study in the Utrecht Patient Oriented Database

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Replication study to evaluate external validity
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01) ANTIBACTERIALS FOR SYSTEMIC USE

  ANTIBACTERIALS FOR SYSTEMIC USE
• Medical condition to be studied:
  Liver injury

Population studied

• Short description of the study population:
  Patients aged 18 years or older hospitalized or referred to the University Medical Centre Utrecht (UMCU) between January 2008 and December 2010.
• 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)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  700

Study design details

• Main study objective:
  To evaluate the external validity of the study protocol on the risk of acute liver injury associated with the use of antibiotics by replicating the study protocol in a Dutch hospital database.
• Outcomes:
  To estimate the risk of acute liver injury associated with antibiotics exposure. To assess the impact of varying outcome definitions and time windows at risk on the effect estimates for the association between antibiotic exposure and acute liver injury.
• Data analysis plan:
  We will compute odds ratios (OR) and 95% confidence intervals of first occurrence of idiopathic acute liver injury associated with current use of antibiotics as compared to non-use with conditional logistic regression.