WP6 Replication Study: The risk of acute liver injury associated with the use of antibiotics: Population based case control study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/5053
• EU PAS number:
  EUPAS2946
• Study ID:
  5053
• Official title and acronym:
  WP6 Replication Study: The risk of acute liver injury associated with the use of antibiotics: Population based case control study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study builds on previous work within the EU-PROTECT Programme (http://www.imi-protect.eu/), that examined different methodological approaches to pharmacoepidemiological research design to investigate, by using a case study of antibiotic induced liver injury, the population case control approach. The study proposes to replicate a previous analysis, to ensure that the baseline model is identical, and then perform sensitivity analyses to understand how changes to input parameters (such as definition of current exposure, code selection, definition of outcome and study periods) may affect the estimates of risk of acute liver injury associated with antibiotics in the general population.The analyses will be performed using the UK General Practice Research Database (CPRD /GPRD). The study design is a population based case control study, with definite and possible cases defined using an algorithm that incorporates consultation diagnosis codes, referral to specialist codes and liver laboratory analyses.Conditional logistic regression is used to analyse the matched data.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Takeda

Networks

PROTECT

Belgium

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/02/2011

Actual: 01/02/2011

Study start date

Planned: 13/11/2012

Actual: 04/12/2012

Data analysis start date

Planned: 08/01/2013

Actual: 08/01/2013

Date of final study report

Planned: 12/12/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda Development Centre (Europe)

Regulatory

• Was the study required by a regulatory body?:
  No