Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia : a study protocol for a retrospective observational study (BICAR)
Gudiol, Carlota (Instituto de Salud Carlos III)
Royo-Cebrecos, Cristina (Instituto de Salud Carlos III)
Tebé, Cristian (Institut d'Investigació Biomèdica de Bellvitge)
Abdala, Edson (University of São Paulo)
Akova, Murat (Hacettepe University School of Medicine)
Álvarez Marín, Rocío (Universidad de Sevilla)
Maestro-de la Calle, Guillermo (Hospital Universitario 12 de Octubre (Madrid))
Cano, Angela (Hospital Universitario Reina Sofía (Còrdova, Espanya))
Cervera, Carlos (University Hospital of Alberta)
Clemente, Wanessa T. (Universidade Federal. Hospital das Clínicas)
Martín-Dávila, Pilar (Hospital Universitario Ramón y Cajal (Madrid))
Freifeld, Alison (University of Nebraska Medical Center)
Gómez, Lucia (Hospital Universitari MútuaTerrassa (Terrassa, Catalunya))
Gottlieb, Thomas (Concord Hospital)
Gurguí, Mercè (Institut d'Investigació Biomèdica Sant Pau)
Herrera, Fabián (Centro de Educación Médica e Investigaciones Clínicas (CEMIC))
Manzur, Adriana (Hospital Rawson)
Maschmeyer, Georg (Academic Teaching Hospital of Charité University Medical School)
Meije, Yolanda (Hospital de Barcelona, SCIAS)
Montejo, Miguel (Hospital Universitario de Cruces (Barakaldo, País Basc))
Peghin, Maddalena (Santa Maria Misericordia University Hospital)
Rodríguez-Baño, Jesús (Instituto de Biomedicina de Sevilla)
Ruiz-Camps, Isabel (Hospital Universitari Vall d'Hebron)
Sukiennik, Teresa Cristina (Hospital Santa Casa de Misericórdia de Porto Alegre)
Carratalà, Jordi (Instituto de Salud Carlos III)
Universitat Autònoma de Barcelona

Date:	2017
Abstract:	Bloodstream infection (BSI) due to extended-spectrum β-lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although β-lactam/β-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. 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 30 days 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. 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. 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).
Grants:	Ministerio de Economía, Industria y Competitividad RD12/0015
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	ESBLs ; Bacteraemia ; Neutropenia ; Beta-lactam/beta-lactamase inhibitors ; Haematologic stem cell transplant
Published in:	BMJ open, Vol. 7 (january 2017) , ISSN 2044-6055

DOI: 10.1136/bmjopen-2016-013268
PMID: 28115333

6 p, 603.3 KB

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