European Prospective Cohort Study on Enterobacteriaceae Showing Resistance to Carbapenems (EURECA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02709408|
Recruitment Status : Unknown
Verified August 2017 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Recruitment status was: Recruiting
First Posted : March 16, 2016
Last Update Posted : August 2, 2017
|Condition or disease|
|Carbapenem Resistant Bacteria Infection|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1025 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||Prospective Observational Study to Assess the Risk Factors, Clinical Management and Outcomes of Hospitalized Patients With Serious Infections Caused by Carbapenem-resistant Enterobacteriaceae and Acinetobacter Baumannii|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||May 2018|
Patients with complicated intrabdominal infections, pneumonia, complicated urinary tract infection and bloodstream infection due to carbapenem-resistant Enterobacteriaceae
Carbapenem-resistant A. baumannii
Patients with bloodstream infections due to carbapenem-resistant Acinetobacter baumannii
Patients with complicated intrabdominal infections, pneumonia, complicated urinary tract infection and bloodstream infection due to carbapenem-susceptible Enterobacteriaceae matched to carbapenem-resistant ones by centre, type of ward, infection type, acquisition and previous duration of hospitalisation.
Admitted control patients
Patients without infection due to Enterobacteriaceae matched to carbapenem-resistant Enterobacteriaceae cases according to centre, ward and previous length of hospitalisation.
- Mortality [ Time Frame: 30 days ]Death by any caused
- Clinical response (failure vs cure or improvement) [ Time Frame: 21 days ]
Clinical failure: non-improvement or deterioration (clinical situation qualified as similar or worse in comparison to that at the diagnosis of bacteremia), death (death of the patient for whatever the reason) or relapse (reappearance of signs and symptoms related to the infection, after the end of treatment).
Clinical cure: resolution of all signs and symptoms related to the infection, and antibiotic therapy is no longer necessary.
Clinical improvement: resolution or partial improvement of signs or symptoms of the infection at the time of assessment but antibiotic therapy is still needed.
TOC was decided at day 21 because it is usually 7 days after the expected average duration of therapy, which is around 10-14 days for the infections included.
- Infection due to CRE [ Time Frame: 1 year ]Infection due to CRE (study 2)
- Length of hospital stay. [ Time Frame: 1 year ]Duration of hospitalisation (study 3)
- Microbiological response (microbiological eradication, failure or uncertain). [ Time Frame: 21 days ]
Microbiological eradication: follow-up cultures from the infection site are negative for the causative pathogen; if follow-up cultures were not performed for clinical reasons but there is clinical cure, the case is classified as "microbiological eradiation, presumptive".
Microbiological failure: follow-up cultures from the infection site are still positive for the causative pathogen.
Uncertain: follow-up cultures were not performed but there is no clinical cure.
- Mortality during hospitalisation. [ Time Frame: 1 year ]Death from any cause only during the hospitalisation of the patient.
- Infection-related mortality [ Time Frame: 30 days ]Death occurring in direct relation to the infection or its complications, and without any other alternative reasonable explanation, in opinion of the local investigator.
- Length of hospital stay after the infection (and ICU stay, mechanical ventilation if appropriate). [ Time Frame: After end of hospitalisation ]Duration of hospitalisation (and in ICU or of mechanical ventilation if appropriate).
- Duration of antibiotic treatment for the episode. [ Time Frame: 30 days ]Days of antibiotic therapy for the infection
- Recurrence [ Time Frame: 30 days ]Reappearance of infection by the same organism.
- Superinfection [ Time Frame: 30 days ]Occurrence of any infection by a different organism.
- Therapy-related adverse events. [ Time Frame: 30 days ]Moderate to severe adverse events related to treatment of the infection.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709408
|Contact: Belén Gutiérrez, MD, PhDemail@example.com|
|Contact: Jesús Sojo, MDfirstname.lastname@example.org|
|Study Chair:||Jesús Rodríguez Baño, MD, PhD||FISEVI (Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla|