Study identification

EU PAS number

EUPAS1000000664

Study ID

1000000664

Official title and acronym

DARWIN EU® - Drug Utilisation Study on Antibiotics in the ‘Reserve’ category of the WHO AWaRe classification of antibiotics for evaluation and monitoring of use

DARWIN EU® study

Yes

Study countries

Denmark
France
Greece
Hungary
Italy
Portugal
Spain

Study description

The WHO 2023 ‎AWaRe classification‎ (who.int) of antibiotics for evaluation and monitoring of use classifies 258 antibiotics into 3 categories (Access/Watch/Reserve) according to their impact on antimicrobial resistance.
The Reserve category comprises critically important antibiotics that serve as last-resort options for treating confirmed or suspected infections caused by multidrug-resistant organisms. These antibiotics are recommended only when all alternative treatments have failed, due to their importance in combating life-threatening infections such as those caused by carbapenem-resistant Enterobacteriaceae and other extended-spectrum beta-lactamase producing bacteria. As of the 2023 update, the Reserve category includes 27 antibiotics, reflecting the WHO’s strategic effort to curb antimicrobial resistance (AMR) by promoting their strict and judicious use in both inpatient and outpatient settings. The inclusion of antibiotics in this group aims to preserve their efficacy by reducing overuse and misuse, particularly in low-resource settings where AMR surveillance may be limited.
The DARWIN EU® P1-C1-003 study focused on the Watch category but there is now interest in including also the other category (Reserve) to characterise the use of most antibiotics, and increased focus on the indication for use.
This study will improve the understanding of the use of WHO AWaRe ‘Reserve’ category antibiotics in routine health care delivery, including indication, treatment duration and trends over time. The results will contribute to the EU efforts to monitor use of antibiotics as part of the global fight against antimicrobial resistance.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Marzyeh Amini

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable