Status: Finalised First registered on: 26/10/2017
Last updated on: 03/05/2021
1. Study identification
EU PAS Register NumberEUPAS21359
Official titleAnti-microbial resistance: choice of therapeutic interventions and outcomes for the treatment of infections caused by MDR Gram-negative pathogens
Study title acronym
Study typeObservational study
Brief description of the studyA systematic literature review of all available treatment guidelines and recommendations and the evidence behind them, and a European cross-sectional six-country survey of antibiotic prescribing patterns and algorithms used in clinical practice. As added values, we will include an MDR treatment outcome analysis using existing Danish data and, if accessible, other European individual-level hospital data.
Was this study requested by a regulator?Yes: EMA
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 belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupDepartment of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Details of (Primary) lead investigator
Title Professor
Last name Sørensen
First name Henrik Toft
Is this study being carried out with the collaboration of a research network?
Aarhus University Consortium (ad hoc)
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

3. Study timelines: initial administrative steps, progress reports and final report
Date when funding contract was signed17/03/201717/03/2017
Start date of data collection17/06/201717/06/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report17/11/201812/10/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Government body
Research councils
EU funding schemeEuropean Medicines Agency100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Ehrenstein
First name Vera
Address line 1Department of Clinical Epidemiology
Address line 2Aarhus University Hospital 
Address line 3 
Phone number (incl. country code)45-87168063 
Alternative phone number 
Fax number (incl. country code) 
Email address
Public Enquiries
Title Professor 
Last name Sørensen 
First name Henrik Toft 
Address line 1Olof Palmes Allé 43-45 
Address line 2 
Address line 3 
CityAarhus N 
Phone number (incl. country code)45-87168063 
Alternative phone number 
Fax number (incl. country code)45-87167215 
Email address