DARWIN EU® Monitoring prescription of essential medicines administered in ICU

Study identification

• 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

Data Analysis and Real World Interrogation Network (DARWIN EU®)

Belgium

Croatia

Denmark

Estonia

Finland

France

Germany

Greece

Hungary

Italy

Netherlands

Norway

Portugal

Spain

Sweden

United Kingdom

Study timelines

Date when funding contract was signed

Planned:12/12/2023

Actual:12/12/2023

Study start date

Planned:01/01/2015

Actual:01/01/2015

Date of final study report

Planned:15/05/2024

Actual:13/12/2024

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