The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/28775
• EU PAS number:
  EUPAS2353
• Study ID:
  28775
• Official title and acronym:
  The risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Netherlands

  Spain

  United Kingdom
• Study description:
  The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work Package 2 and Working Group 1. The primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on 5 key Drug / adverse events (D-AEs) pairs performed in different databases will be evaluated. The Use of antibiotics associated with the risk of acute liver injury is one of the key D-Ae pair of interest. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of studying the association under investigation.
• Study status:
  Finalised

Research institution and networks

Institutions

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Pharmacoepidemiology Group, London School of Hygiene & Tropical Medicine (LSHTM)

United Kingdom

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

Netherlands

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Pharmacoepidemiology and Pharmacovigilance department, Spanish Agency of medicines and medical devices (AEMPS)

Spain

Agencia Espanola de Medicamentos y Productos Sanitarios (AEMPS) Spain, Lægemiddelstyrelsen (DKMA) Denmark, Ludwig-Maximilians-Universität-München (LMU Muenchen) Germany, European Medicines Agency (EMA) United Kingdom, Amgen United Kingdom, LSHTM United Kingdom

Networks

PROTECT

Belgium

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

United Kingdom

Contact details

Ana Ruigomez

Study contact

[e-mail]

Ana Ruigomez

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 19/08/2009

Actual: 19/08/2009

Data collection

Planned: 03/10/2011

Actual: 03/10/2011

Date of final study report

Planned: 01/02/2013

Actual: 01/07/2013

Sources of funding

EU institutional research programme

Pharmaceutical company and other private sector 

More details on funding

Amgen, AstraZeneca, Genzyme, GSK, MerckSerono, Novartis, Roche, Pfizer, Innovative Medicines Initiative (IMI)

Study protocol

Initial protocol

PROTECT_WP2Final Protocol_AntibLiver_Amend2_July2012

Regulatory

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