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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/9017
• EU PAS number:
  EUPAS7730
• Study ID:
  9017
• Official title and acronym:
  The risk of acute liver injury with the use of antibiotics. A replication study in the Utrecht Patient Oriented Database
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  The study described in this protocol is performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium). The specific aims of this study are:• 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, • to study the impact of case validation on the effect estimate for the association between antibiotic exposure and acute liver injury.Of the selected drug-adverse event pairs selected in PROTECT, this study will concentrate on the association between antibiotic use and acute liver injury. On this topic, two sub-studies are performed: a descriptive/outcome validation study and an association study. The descriptive/outcome validation study has been conducted within the Utrecht Patient Oriented Database (UPOD). Cases of acute liver injury have been identified using hospital discharge diagnoses and/or abnormal laboratory test results related to liver injury. The proposed association study will be performed using UPOD and GP databases.
• Study status:
  Finalised

Research institution and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Networks

PROTECT

Belgium

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 01/01/2012

Actual: 01/01/2012

Study start date

Planned: 02/04/2012

Actual: 02/04/2012

Data analysis start date

Planned: 01/07/2013

Date of interim report, if expected

Planned: 02/12/2013

Date of final study report

Planned: 30/06/2014

Actual: 30/06/2014

Sources of funding

EU institutional research programme

More details on funding

IMI-PROTECT

Study protocol

Initial protocol

WP6_SAP_UPOD2 PROTECT_AB-ALI_11-7-2013

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable