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Current status: Recruitment Completed
combacte-care

EURECA

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 first obtained high‐quality, observational data about the clinical management, best-available therapy, outcome predictors, mortality and safety of the antibiotics used. Secondary objectives were 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 were also 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).

All cohort data was collected in such a way that scientists will be able to use the patients as historical controls in future clinical trials. For example, patients were followed as they are seen by the assessing physician and data were 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 information

EURECA focused 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 participated: in Spain, Italy, Greece, Turkey, Serbia, Croatia, Bosnia, Herzegovina, Albania, Macedonia, Kosovo, Bulgaria, and Romania. The patient cohorts included newborns and children, as well as adults, with one of the infections listed above.

Study team members

  • Almudena de la Serna

    Project Management Office / Academic / Hospital Universitario Virgen Macarena

  • Alvaro Pascual

    Academic / Hospital Universitario Virgen Macarena

  • Belén Gutierrez

    Research physician / Academic / Hospital Universitario Virgen Macarena

Study level information

General information
  • Study NO NCT02709408
  • Study Name EURECA
  • Study Type Observational
  • Study Status Recruitment Complete
  • Enrollment Period 05/16 - 04/18
Enrollment
  • Total subjects planned 2000
  • Total subjects screened 2266
  • Total subjects enrolled 2266
  • Total subjects completed 1522

Study timeline

Light blue
Preparation phase
Dark blue
Trial period

Country level information

Filter
Sites planned 1
Sites activated 1
Albania
Subjects
planned
14
Subjects
enrolled
3
Subjects
completed
1
Subjects completed
33.3%
Sites planned 1
Sites activated 1
Croatia
Subjects
planned
28
Subjects
enrolled
8
Subjects
completed
8
Subjects completed
53.3%
Sites planned 11
Sites activated 11
Greece
Subjects
planned
644
Subjects
enrolled
611
Subjects
completed
439
Subjects completed
82.8%
Sites planned 9
Sites activated 10
Italy
Subjects
planned
693
Subjects
enrolled
204
Subjects
completed
117
Subjects completed
63.6%
Sites planned 1
Sites activated 1
Kosovo
Subjects
planned
32
Subjects
enrolled
32
Subjects
completed
32
Subjects completed
100.0%
Sites planned 1
Sites activated 1
Montenegro
Subjects
planned
28
Subjects
enrolled
17
Subjects
completed
17
Subjects completed
100.0%
Sites planned 7
Sites activated 7
Romania
Subjects
planned
153
Subjects
enrolled
102
Subjects
completed
62
Subjects completed
65.3%
Sites planned 5
Sites activated 6
Serbia
Subjects
planned
138
Subjects
enrolled
423
Subjects
completed
311
Subjects completed
92.8%
Sites planned 8
Sites activated 8
Spain
Subjects
planned
267
Subjects
enrolled
905
Subjects
completed
578
Subjects completed
104.0%
Sites planned 5
Sites activated 5
Turkey
Subjects
planned
115
Subjects
enrolled
164
Subjects
completed
35
Subjects completed
40.2%
10/09/2020

First Subject First Visit

08/09/2020

EURECA Finalizes Database Lock