dc.contributor.editor | Pascual Hernández, Álvaro | es |
dc.creator | Gutiérrez Gutiérrez, Belén | es |
dc.creator | Sojo Dorado, Jesús | es |
dc.creator | Bravo Ferrer, José | es |
dc.creator | Rodríguez-Baño, Jesús | es |
dc.date.accessioned | 2020-03-31T09:03:53Z | |
dc.date.available | 2020-03-31T09:03:53Z | |
dc.date.issued | 2017-02-07 | |
dc.identifier.citation | Gutiérrez Gutiérrez, B., Sojo Dorado, J., Bravo Ferrer, J. y Rodriguez Baño, J. (2017). EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA): a protocol of a European multicentre observational study. BMJ Open., 7 (4), 1-11. | |
dc.identifier.issn | 2044-6055 | es |
dc.identifier.uri | https://hdl.handle.net/11441/94720 | |
dc.description.abstract | Introduction: The rapid worldwide spread of
carbapenem-resistant Enterobacteriaceae (CRE)
constitutes a major challenge. The aim of the EUropean
prospective cohort study on Enterobacteriaceae
showing REsistance to CArbapenems (EURECA), which
is part of the Innovative Medicines Initiative Joint
Undertaking (IMI JU) funded COMBACTE-CARE project,
is to investigate risk factors for and outcome
determinants of CRE infections to inform randomised
clinical trial designs and to provide a historical cohort
that could eventually be used for future comparisons
with new drugs targeting CRE.
Methods: A multicentre (50 sites), multinational
(11 European countries), analytical observational
project was designed, comprising 3 studies. The aims
of study 1 (a prospective cohort study) include
characterising the features, clinical management and
outcomes of hospitalised patients with intra-abdominal
infection, pneumonia, complicated urinary tract
infections and bloodstream infections caused by CRE
(202 patients in each group). The main outcomes will
be 30-day all-cause mortality and clinical response.
Study 2 (a nested case–control study) will identify
the risk factors for target infections caused by CRE;
248 selected patients from study 1 will be matched
with patients with carbapenem-susceptible
Enterobacteriaceae (1:1) and with hospitalised patients
(1:3) and will provide a historical cohort of patients
with CRE infections. Study 3 (a matched cohort study)
will follow patients in study 2 in order to assess
mortality, length of stay and hospital costs associated
with CRE. All patients will be followed for 30 days.
Different, up-to-date statistical methods will be applied
to come to unbiased estimates for all 3 studies.
Ethics and dissemination: Before-study sites will be
initiated, approval will be sought from appropriate
regulatory agencies and local Ethics Committees of
Research or Institutional Review Boards (IRBs) to
conduct the study in accordance with regulatory requirements. This is an observational study and
therefore no intervention in the diagnosis, management
or treatment of the patients will be required on behalf
of the investigation. Any formal presentation or
publication of data collected from this study will be
considered as a joint publication by the participating
physician(s) and will follow the recommendations of
the International Committee of Medical Journal Editors
(ICMJE) for authorship. | es |
dc.description.sponsorship | Innovative Medicine Initiative (IMI) | es |
dc.description.sponsorship | European Union's Seventh Framework Programme (FP7) | es |
dc.description.sponsorship | Spanish Network for Research in Infectious Diseases [REIPI RD12/0015, RD16/2016] | es |
dc.format | application/pdf | es |
dc.format.extent | 11 | es |
dc.language.iso | eng | es |
dc.relation.ispartof | BMJ Open., 7 (4), 1-11. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | EURECA. | es |
dc.subject | Enterobacteriaceae showing REsistance to CArbapenems. | es |
dc.subject | Ethics Committees of Research. | es |
dc.subject | BAT. | es |
dc.title | EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA): a protocol of a European multicentre observational study | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Instituto de Biomedicina de Sevilla. Grupo de Resistencia microbiana e infecciones complejas. | es |
dc.relation.publisherversion | https://bmjopen.bmj.com/content/7/4/e015365 | es |
dc.identifier.doi | 10.1136/bmjopen-2016-015365 | es |
dc.journaltitle | BMJ Open. | es |
dc.publication.volumen | 7 | es |
dc.publication.issue | 4 | es |
dc.publication.initialPage | 1 | es |
dc.publication.endPage | 11 | es |