Status: Finalised First registered on: 27/01/2012
Last updated on: 07/03/2019
1. Study identification
EU PAS Register NumberEUPAS2353
Official titleThe risk of acute liver injury associated with the use of antibiotics. A methodological comparison across epidemiological data sources
Study title acronym
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCEIFE
Department/Research groupFundación Centro Español de Investigación Farmacoepidemiológica
Organisation/affiliationFundación CEIFE
Website/Homepagewww.ceife.es
Details of (Primary) lead investigator
Title Dr
Last name Ruigomez
First name Ana
Is this study being carried out with the collaboration of a research network?
Yes

PROTECT
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?6

Utrecht University Pharmacoepidemiology Center
LSHTM
CEIFE
AEMPS
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
Countries in which this study is being conducted
International study

Denmark
Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/08/200919/08/2009
Start date of data collection03/10/201103/10/2011
Start date of data analysis
Date of interim report, if expected
Date of final study report01/02/201301/07/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAmgen, AstraZeneca, Genzyme, GSK, MerckSerono, Novartis, Roche, Pfizer50
Charities
Government body
Research councils
EU funding schemeInnovative Medicines Initiative (IMI)50
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ruigomez
First name Ana
Address line 1Almirante 28
Address line 2 
Address line 3 
CityMadrid 
Postcode28004 
CountrySpain
Phone number (incl. country code)34915313404 
Alternative phone number 
Fax number (incl. country code)34915312871 
Email address aruigomez@ceife.es
Public Enquiries
Title Dr 
Last name Kurz 
First name Xavier 
Address line 1European Medicines Agency 
Address line 27 Westferry Circus 
Address line 3Canary Wharf 
CityLondon 
PostcodeE14 4HB 
CountryUnited Kingdom 
Phone number (incl. country code)442074188400 
Alternative phone number 
Fax number (incl. country code) 
Email address protect_support@ema.europa.eu 
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