Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)

Gudiol, C; Royo-Cebrecos, C; Tebe, C; Abdala, E; Akova, M; Alvarez, R; Maestro-de la Calle, G; Cano, A; Cervera, C; Clemente, WT; Martin-Davila, P; Freifeld, A; Gomez, L; Gottlieb, T; Gurgui, M; Herrera, F; Manzur, A; Maschmeyer, G; Meije, Y; Montejo, M; Peghin, M; Rodriguez-Bano, J; Ruiz-Camps, I; Sukiennik, TC; Carratala, J

Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)

Introduction Bloodstream infection (BSI) due to extended-spectrum -lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although -lactam/-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BS...

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Autores:	Gudiol, C, Royo-Cebrecos, C, Tebe, C, Abdala, E, Akova, M, Alvarez, R, Maestro-de la Calle, G, Cano, A, Cervera, C, Clemente, WT, Martin-Davila, P, Freifeld, A, Gomez, L, Gottlieb, T, Gurgui, M, Herrera, F, Manzur, A, Maschmeyer, G, Meije, Y, Montejo, M, Peghin, M, Rodriguez-Bano, J, Ruiz-Camps, I, Sukiennik, TC, Carratala, J
Tipo de recurso:	artículo
Estado:	Versión publicada
Fecha de publicación:	2017
País:	España
Institución:	Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:	r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:	oai:iibsantpau.fundanetsuite.com:p6720
Acceso en línea:	https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=6720
Access Level:	acceso abierto
Palabra clave:	ESBLs Bacteraemia Neutropenia beta-lactam beta-lactamase inhibitors haematologic stem cell transplant

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spelling	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)Gudiol, CRoyo-Cebrecos, CTebe, CAbdala, EAkova, MAlvarez, RMaestro-de la Calle, GCano, ACervera, CClemente, WTMartin-Davila, PFreifeld, AGomez, LGottlieb, TGurgui, MHerrera, FManzur, AMaschmeyer, GMeije, YMontejo, MPeghin, MRodriguez-Bano, JRuiz-Camps, ISukiennik, TCCarratala, JESBLsBacteraemiaNeutropeniabeta-lactambeta-lactamase inhibitorshaematologic stem cell transplantIntroduction Bloodstream infection (BSI) due to extended-spectrum -lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although -lactam/-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BSI due to these resistant organisms in the general population, their usefulness for the treatment of BSI due to ESBL-GNB in haematological patients with neutropaenia is yet to be elucidated. The aim of the BICAR study is to compare the efficacy of BLBLI combinations with that of carbapenems for the treatment of BSI due to an ESBL-GNB in this population. Methods and analysis A multinational, multicentre, observational retrospective study. Episodes of BSI due to ESBL-GNB occurring in haematological patients and haematopoietic stem cell transplant recipients with neutropaenia from 1 January 2006 to 31 March 2015 will be analysed. The primary end point will be case-fatality rate within 30days of onset of BSI. The secondary end points will be 7-day and 14-day case-fatality rates, microbiological failure, colonisation/infection by resistant bacteria, superinfection, intensive care unit admission and development of adverse events. Sample size The number of expected episodes of BSI due to ESBL-GNB in the participant centres will be 260 with a ratio of control to experimental participants of 2. Ethics and dissemination The protocol of the study was approved at the first site by the Research Ethics Committee (REC) of Hospital Universitari de Bellvitge. Approval will be also sought from all relevant RECs. Any formal presentation or publication of data from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). The study has been endorsed by the European Study Group for Bloodstream Infection and Sepsis (ESGBIS) and the European Study Group for Infections in Compromised Hosts (ESGICH).BMJ PUBLISHING GROUP2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=6720BMJ OpenISSN: 20446055reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p67202026-06-14T12:41:47Z
dc.title.none.fl_str_mv	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)
title	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)
spellingShingle	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR) Gudiol, C ESBLs Bacteraemia Neutropenia beta-lactam beta-lactamase inhibitors haematologic stem cell transplant
title_short	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)
title_full	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)
title_fullStr	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)
title_full_unstemmed	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)
title_sort	Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)
dc.creator.none.fl_str_mv	Gudiol, C Royo-Cebrecos, C Tebe, C Abdala, E Akova, M Alvarez, R Maestro-de la Calle, G Cano, A Cervera, C Clemente, WT Martin-Davila, P Freifeld, A Gomez, L Gottlieb, T Gurgui, M Herrera, F Manzur, A Maschmeyer, G Meije, Y Montejo, M Peghin, M Rodriguez-Bano, J Ruiz-Camps, I Sukiennik, TC Carratala, J
author	Gudiol, C
author_facet	Gudiol, C Royo-Cebrecos, C Tebe, C Abdala, E Akova, M Alvarez, R Maestro-de la Calle, G Cano, A Cervera, C Clemente, WT Martin-Davila, P Freifeld, A Gomez, L Gottlieb, T Gurgui, M Herrera, F Manzur, A Maschmeyer, G Meije, Y Montejo, M Peghin, M Rodriguez-Bano, J Ruiz-Camps, I Sukiennik, TC Carratala, J
author_role	author
author2	Royo-Cebrecos, C Tebe, C Abdala, E Akova, M Alvarez, R Maestro-de la Calle, G Cano, A Cervera, C Clemente, WT Martin-Davila, P Freifeld, A Gomez, L Gottlieb, T Gurgui, M Herrera, F Manzur, A Maschmeyer, G Meije, Y Montejo, M Peghin, M Rodriguez-Bano, J Ruiz-Camps, I Sukiennik, TC Carratala, J
author2_role	author author author author author author author author author author author author author author author author author author author author author author author author
dc.subject.none.fl_str_mv	ESBLs Bacteraemia Neutropenia beta-lactam beta-lactamase inhibitors haematologic stem cell transplant
topic	ESBLs Bacteraemia Neutropenia beta-lactam beta-lactamase inhibitors haematologic stem cell transplant
description	Introduction Bloodstream infection (BSI) due to extended-spectrum -lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although -lactam/-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BSI due to these resistant organisms in the general population, their usefulness for the treatment of BSI due to ESBL-GNB in haematological patients with neutropaenia is yet to be elucidated. The aim of the BICAR study is to compare the efficacy of BLBLI combinations with that of carbapenems for the treatment of BSI due to an ESBL-GNB in this population. Methods and analysis A multinational, multicentre, observational retrospective study. Episodes of BSI due to ESBL-GNB occurring in haematological patients and haematopoietic stem cell transplant recipients with neutropaenia from 1 January 2006 to 31 March 2015 will be analysed. The primary end point will be case-fatality rate within 30days of onset of BSI. The secondary end points will be 7-day and 14-day case-fatality rates, microbiological failure, colonisation/infection by resistant bacteria, superinfection, intensive care unit admission and development of adverse events. Sample size The number of expected episodes of BSI due to ESBL-GNB in the participant centres will be 260 with a ratio of control to experimental participants of 2. Ethics and dissemination The protocol of the study was approved at the first site by the Research Ethics Committee (REC) of Hospital Universitari de Bellvitge. Approval will be also sought from all relevant RECs. Any formal presentation or publication of data from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). The study has been endorsed by the European Study Group for Bloodstream Infection and Sepsis (ESGBIS) and the European Study Group for Infections in Compromised Hosts (ESGICH).
publishDate	2017
dc.date.none.fl_str_mv	2017
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dc.language.none.fl_str_mv	Inglés
language_invalid_str_mv	Inglés
dc.rights.none.fl_str_mv	info:eu-repo/semantics/openAccess
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dc.publisher.none.fl_str_mv	BMJ PUBLISHING GROUP
publisher.none.fl_str_mv	BMJ PUBLISHING GROUP
dc.source.none.fl_str_mv	BMJ Open ISSN: 20446055 reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
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Clinical efficacy of beta-lactam/beta-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum beta-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR)

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