Status: Finalised First registered on: 03/02/2023
Last updated on: 28/03/2023
1. Study identification
EU PAS Register NumberEUPAS103381
Official titleDARWIN EU® - DUS of Antibiotics in the ‘Watch’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use
Study title acronym
Study typeObservational study
Brief description of the studyThis drug utilisation study aims to characterise the incidence of prescription of the 141 antibiotics in the ‘Watch’ list, including indication and treatment duration, for the period 2012-2021, stratified by year and country. For this study, databases from 5 European countries will be used namely IPCI (Nl), CPRD Gold (UK), SIDIAP (Spain), IQVIA DA (Germany), IMASIS (Spain) and CHUBX (France). Specific objectives of this study are the following: (i) To investigate the incidence and prevalence of use of antibiotics (from the WHO Watch list) stratified by calendar year, age, sex and country/database during the study period 2012-2021. (ii) To explore duration of antibiotic use as well as indication for antibiotic prescribing/dispensing.
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 nameDARWIN EU CC
Centre locationRotterdam, The Netherlands
Details of (Primary) lead investigator
Title Dr
Last name Verhamme
First name Katia
Is this study being carried out with the collaboration of a research network?
Yes

DARWIN EU CC
Other centres where this study is being conducted
Multiple centres

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

IDIAPJGol
Health Data Science
IQVIA
PSMAR, Spain
CHUBX, France
University of Oxford, UK
Countries in which this study is being conducted
International study

France
Germany
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed03/11/202203/11/2022
Start date of data collection01/12/202201/12/2021
Start date of data analysis02/01/202302/01/2023
Date of interim report, if expected
Date of final study report06/02/202315/02/2023
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 bodyEMA100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Verhamme
First name Katia
Address line 1Dr. Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands
Phone number (incl. country code)31107044129 
Alternative phone number 
Fax number (incl. country code) 
Email address k.verhamme@erasmusmc.nl
Public Enquiries
Title Dr 
Last name Verhamme 
First name Katia 
Address line 1Dr. Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands 
Phone number (incl. country code)31107044129 
Alternative phone number 
Fax number (incl. country code) 
Email address k.verhamme@erasmusmc.nl 
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