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

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
First published:
26/06/2013
Network
ENCePP partner

Contact details

Ana Ruigomez

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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
English (483.48 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable