Status: Finalised First registered on: 22/10/2014
Last updated on: 20/03/2015
1. Study identification
EU PAS Register NumberEUPAS7730
Official titleThe risk of acute liver injury with the use of antibiotics. A replication study in the Utrecht Patient Oriented Database.
Study title acronym
Study typeObservational study
Brief description of the studyThe 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
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 belongsUtrecht University Pharmacoepidemiology Center
Department/Research groupDivision of Pharmacoepidemiology & Clinical Pharmacology
Organisation/affiliationUtrecht Institute for Pharmaceutical Sciences
Website/Homepagewww.uu.nl/pecp
Details of (Primary) lead investigator
Title Dr
Last name De Bruin
First name Marie L.
Is this study being carried out with the collaboration of a research network?
Yes

Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201201/01/2012
Start date of data collection02/04/201202/04/2012
Start date of data analysis01/07/2013
Date of interim report, if expected02/12/2013
Date of final study report30/06/201430/06/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeIMI-PROTECT100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name De Bruin
First name Marie L.
Address line 1Universiteitsweg 99
Address line 2PO Box 80082 
Address line 3 
CityUtrecht 
Postcode3508 TB 
CountryNetherlands
Phone number (incl. country code)31-6-20294612 
Alternative phone number 
Fax number (incl. country code)31-30-2539166 
Email address m.l.debruin@uu.nl
Public Enquiries
Title Dr 
Last name De Bruin 
First name Marie L. 
Address line 1Universiteitsweg 99 
Address line 2PO Box 80082 
Address line 3 
CityUtrecht 
Postcode3508 TB 
CountryNetherlands 
Phone number (incl. country code)31-6-20294612 
Alternative phone number 
Fax number (incl. country code)31-30-2539166 
Email address m.l.debruin@uu.nl 
Top