Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000089

EU PAS number

EUPAS1000000089

Study ID

1000000089

Official title and acronym

DARWIN EU® Monitoring prescription of essential medicines administered in ICU

DARWIN EU® study

Yes

Study countries

France
Portugal
Spain

Study description

Research question:
What is the annual prescription rate of selected medicines of importance for public health emergencies, specifically used in Intensive Care Unit (ICU)?
Study objectives:
- To estimate annual rate of prescription of selected medicines in a cohort of patients being hospitalized, stratified by Intensive Care Unit (ICU) admission (yes/no).
- To characterize the two cohorts of hospitalized patients (ICU admission (yes/no)) who initiated treatment with drug of interest in terms of demographics, presence of COVID-19 infection (yes/no), and use of mechanical ventilation (yes/no).
- To determine dose at treatment initiation and duration of treatment with selected medications in the overall cohort of hospitalized patients being treated with the drug of interest as well as in groups stratified by admission to ICU and mechanical ventilation. Optionally, consumption of the specified drugs at hospital level may be provided.

Study status

Finalised
Research institutions and networks

Networks

Contact details

Dina Vojinovic

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

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

DARWIN_EU_D2.2.3_Protocol_P2-C1-014_DUS of medicines in ICU at risk of shortages_v2.1.pdf

English (861.84 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