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)
Por:
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
Publicada:
1 ene 2017
Resumen:
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).
Filiaciones:
Gudiol, C:
Univ Barcelona, Bellvitge Univ Hosp, Dept Infect Dis, IDIBELL, Barcelona, Spain
Duran & Reynals Hosp, ICO, Barcelona, Spain
Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain
Royo-Cebrecos, C:
Univ Barcelona, Bellvitge Univ Hosp, Dept Infect Dis, IDIBELL, Barcelona, Spain
Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain
Tebe, C:
Univ Rovira & Virgili, Inst Biomed Res Bellvitge, Stat Advisory Serv, Barcelona, Spain
Abdala, E:
Univ Sao Paulo, Inst Canc Estado Sao Paulo, Fac Med, Sao Paulo, Brazil
Akova, M:
Hacettepe Univ, Sch Med, Ankara, Turkey
Alvarez, R:
Univ Seville, Inst Biomed Seville IBiS, Infect Dis Res Grp,Univ Hosp Virgen del Rocio, Clin Unit Infect Dis Microbiol & Prevent Med,CSIC, Seville, Spain
Univ Seville, Inst Biomed Seville IBiS, Infect Dis Res Grp,Univ Hosp Virgen Macarena, Clin Unit Infect Dis Microbiol & Prevent Med,CSIC, Seville, Spain
Maestro-de la Calle, G:
Univ Complutense, 12 Octubre Univ Hosp, Sch Med, Infect Dis Unit,Inst Invest Hosp 12 Octubre i 12, Madrid, Spain
Cano, A:
Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain
Reina Sofia Univ Hosp IMIBIC UCO, Cordoba, Spain
Cervera, C:
Univ Hosp Alberta, Edmonton, AB, Canada
Clemente, WT:
Univ Fed Minas Gerais, Hosp Clin, Digest Transplant Serv, Belo Horizonte, MG, Brazil
Martin-Davila, P:
Hosp Ramon & Cajal, Dept Infect Dis, Madrid, Spain
Freifeld, A:
Univ Nebraska Med Ctr, Dept Internal Med, Infect Dis Sect, Omaha, NE USA
Gomez, L:
Univ Hosp Mutua de Terrassa, Dept Internal Med, Barcelona, Spain
Gottlieb, T:
Concord Hosp, Dept Microbiol & Infect Dis, Concord, NSW, Australia
Gurgui, M:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Infect Dis Unit, Barcelona, Spain
Univ Autonoma Barcelona, Inst Invest Biomed St Pau, Barcelona, Spain
Herrera, F:
CEMIC, Infect Dis Sect, Dept Med, Buenos Aires, DF, Argentina
Manzur, A:
Hosp Rawson, Infect Dis, San Juan, Argentina
Maschmeyer, G:
Charite, Klinikum Ernst von Bergmann, Acad Teaching Hosp, Dept Hematol Oncol & Palliat Care,Med Sch, Berlin, Germany
Meije, Y:
Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain
Barcelona Hosp, Dept Internal Med, Infect Dis Unit, SCIAS, Barcelona, Spain
Montejo, M:
Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain
Cruces Univ Hosp, Infect Dis Unit, Bilbao, Spain
Peghin, M:
Santa Maria Misericordia Univ Hosp, Div Infect Dis, Udine, Italy
Rodriguez-Bano, J:
Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain
Univ Seville, Univ Hosp Virgen Macarena & Virgen del Rocio IBiS, Dept Med, Clin Unit Infect Dis Microbiol & Prevent Med, Seville, Spain
Ruiz-Camps, I:
Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain
Vall dHebron Univ Hosp, Dept Infect Dis, Barcelona, Spain
Sukiennik, TC:
Hosp Santa Casa Misericordia Porto Alegre, Porto Alegre, RS, Brazil
Carratala, J:
Univ Barcelona, Bellvitge Univ Hosp, Dept Infect Dis, IDIBELL, Barcelona, Spain
Inst Salud Carlos III, REIPI Spanish Network Res Infect Dis, Madrid, Spain
Gold, Green Published
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