European prospective cohort study on Enterobacteriaceae Showing resistance to carbapenems
EURECA is a prospective observational study on cohorts of patients with serious carbapenem-resistant Gram-negative bacterial infections. It aims to learn how patients across Europe are infected and currently treated. And which subgroups of patients respond well to which treatments.
CRE and CRAB
This study will first obtain high‐quality, observational data about the clinical management, best-available therapy, outcome predictors, mortality and safety of the antibiotics used. Secondary objectives are specific questions regarding the impact of carbapenem minimal inhibitory concentration, or specific mechanisms of resistance (e.g. carbapenemase types) or phenotypes (e.g. colistin resistance). The risk factors, impact on mortality, and cost of infections caused by CRE will also be studied.
Ultimately, EURECA will lead the way towards better management of patients with complicated intra-abdominal infections (cIAI), healthcare-associated pneumonia (HCAP), complicated urinary tract infections (cUTI), and bloodstream infections (BSI). All due to carbapenem-resistant Enterobacteriaceae (CRE) and Acinetobacter baumannii (CRAB).
EURECA will focus in particular on building capacity in clinical sites in south-eastern Europe, where growing CRE infection rates have been reported in recent years. Some 50 hospitals are participating: in Spain, Italy, Greece, Turkey, Serbia, Croatia, Bosnia, Herzegovina, Albania, Macedonia, Kosovo, Bulgaria, and Romania. The patient cohorts include newborns and children, as well as adults, with one of the infections listed above.
All cohort data is collected in such a way that scientists will be able to use the patients as historical controls in future clinical trials. For example, patients are followed as they are seen by the assessing physician and data will be collected at time intervals that will be most relevant when applied to new treatment regimens. In doing so, EURECA is aiming to limit the number of patients that need to be enrolled in future trials, which will significantly speed up product development and approval.
Study team members
Almudena de la Serna
Project Management Office / Academic / Hospital Universitario Virgen Macarena
Academic / Hospital Universitario Virgen Macarena
Research physician / Academic / Hospital Universitario Virgen Macarena
Study level information
- Study NO NCT02709408
- Study Name EURECA
- Study Type Observational
- Study Status Active Recruiting
- Enrollment Period 05/16 - 04/18
- Total subjects planned 2000
- Total subjects screened 1161
- Total subjects enrolled 1657
- Total subjects completed 0
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- Preparation phase
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- Trial period
Country level information