Study identification

PURI

https://redirect.ema.europa.eu/resource/103382

EU PAS number

EUPAS103381

Study ID

103382

Official title and acronym

DARWIN EU® DUS of Antibiotics in the ‘Watch’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use

DARWIN EU® study

Yes

Study countries

France
Germany
Netherlands
Spain
United Kingdom

Study description

This 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.

Study status

Finalised
Research institution and networks

Institutions

PSMAR Spain, CHUBX France, University of Oxford UK

Networks

Contact details

Katia Verhamme

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

D2.2.3_Darwin_EU_Study_Protocol_C1-003_v2.2

English (970.76 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable