Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamaseproducing Enterobacteriaceae in haematological patients with neutropaenia

A study protocol for a retrospective observational study (BICAR)

C. Gudiol, C. Royo-Cebrecos, C. Tebe, E. Abdala, M. Akova, R. Álvarez, G. Maestro-De La Calle, A. Cano, C. Cervera, W. T. Clemente, P. Martín-Dávila, Alison Gail Freifeld, L. Gómez, T. Gottlieb, M. Gurguí, F. Herrera, A. Manzur, G. Maschmeyer, Y. Meije, M. Montejo & 5 others M. Peghin, J. Rodríguez-Banõ, I. Ruiz-Camps, T. C. Sukiennik, J. Carratalà

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Introduction: Bloodstream infection (BSI) due to extended-spectrum â-lactamase-producing Gramnegative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although â-lactam/â-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 casefatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day casefatality 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).

Original languageEnglish (US)
Article numbere013268
JournalBMJ Open
Volume7
Issue number1
DOIs
StatePublished - Jan 1 2017

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Lactams
Enterobacteriaceae
Observational Studies
Retrospective Studies
Infection
Therapeutics
Carbapenems
Publications
Superinfection
Research Ethics Committees
Hematopoietic Stem Cells
Ethics
Sample Size
Bacillus
Population
Intensive Care Units
Sepsis
Research Personnel
Bacteria
Transplants

ASJC Scopus subject areas

  • Medicine(all)

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Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamaseproducing 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.; Álvarez, R.; Maestro-De La Calle, G.; Cano, A.; Cervera, C.; Clemente, W. T.; Martín-Dávila, P.; Freifeld, Alison Gail; Gómez, L.; Gottlieb, T.; Gurguí, M.; Herrera, F.; Manzur, A.; Maschmeyer, G.; Meije, Y.; Montejo, M.; Peghin, M.; Rodríguez-Banõ, J.; Ruiz-Camps, I.; Sukiennik, T. C.; Carratalà, J.

In: BMJ Open, Vol. 7, No. 1, e013268, 01.01.2017.

Research output: Contribution to journalArticle

Gudiol, C, Royo-Cebrecos, C, Tebe, C, Abdala, E, Akova, M, Álvarez, R, Maestro-De La Calle, G, Cano, A, Cervera, C, Clemente, WT, Martín-Dávila, P, Freifeld, AG, Gómez, L, Gottlieb, T, Gurguí, M, Herrera, F, Manzur, A, Maschmeyer, G, Meije, Y, Montejo, M, Peghin, M, Rodríguez-Banõ, J, Ruiz-Camps, I, Sukiennik, TC & Carratalà, J 2017, 'Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamaseproducing Enterobacteriaceae in haematological patients with neutropaenia: A study protocol for a retrospective observational study (BICAR)', BMJ Open, vol. 7, no. 1, e013268. https://doi.org/10.1136/bmjopen-2016-013268
Gudiol, C. ; Royo-Cebrecos, C. ; Tebe, C. ; Abdala, E. ; Akova, M. ; Álvarez, R. ; Maestro-De La Calle, G. ; Cano, A. ; Cervera, C. ; Clemente, W. T. ; Martín-Dávila, P. ; Freifeld, Alison Gail ; Gómez, L. ; Gottlieb, T. ; Gurguí, M. ; Herrera, F. ; Manzur, A. ; Maschmeyer, G. ; Meije, Y. ; Montejo, M. ; Peghin, M. ; Rodríguez-Banõ, J. ; Ruiz-Camps, I. ; Sukiennik, T. C. ; Carratalà, J. / Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamaseproducing Enterobacteriaceae in haematological patients with neutropaenia : A study protocol for a retrospective observational study (BICAR). In: BMJ Open. 2017 ; Vol. 7, No. 1.
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abstract = "Introduction: Bloodstream infection (BSI) due to extended-spectrum {\^a}-lactamase-producing Gramnegative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although {\^a}-lactam/{\^a}-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 casefatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day casefatality 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).",
author = "C. Gudiol and C. Royo-Cebrecos and C. Tebe and E. Abdala and M. Akova and R. {\'A}lvarez and {Maestro-De La Calle}, G. and A. Cano and C. Cervera and Clemente, {W. T.} and P. Mart{\'i}n-D{\'a}vila and Freifeld, {Alison Gail} and L. G{\'o}mez and T. Gottlieb and M. Gurgu{\'i} and F. Herrera and A. Manzur and G. Maschmeyer and Y. Meije and M. Montejo and M. Peghin and J. Rodr{\'i}guez-Ban{\~o} and I. Ruiz-Camps and Sukiennik, {T. C.} and J. Carratal{\`a}",
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T1 - Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamaseproducing Enterobacteriaceae in haematological patients with neutropaenia

T2 - A study protocol for a retrospective observational study (BICAR)

AU - Gudiol, C.

AU - Royo-Cebrecos, C.

AU - Tebe, C.

AU - Abdala, E.

AU - Akova, M.

AU - Álvarez, R.

AU - Maestro-De La Calle, G.

AU - Cano, A.

AU - Cervera, C.

AU - Clemente, W. T.

AU - Martín-Dávila, P.

AU - Freifeld, Alison Gail

AU - Gómez, L.

AU - Gottlieb, T.

AU - Gurguí, M.

AU - Herrera, F.

AU - Manzur, A.

AU - Maschmeyer, G.

AU - Meije, Y.

AU - Montejo, M.

AU - Peghin, M.

AU - Rodríguez-Banõ, J.

AU - Ruiz-Camps, I.

AU - Sukiennik, T. C.

AU - Carratalà, J.

PY - 2017/1/1

Y1 - 2017/1/1

N2 - Introduction: Bloodstream infection (BSI) due to extended-spectrum â-lactamase-producing Gramnegative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although â-lactam/â-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 casefatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day casefatality 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).

AB - Introduction: Bloodstream infection (BSI) due to extended-spectrum â-lactamase-producing Gramnegative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although â-lactam/â-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 casefatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day casefatality 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).

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