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 A, Gómez L, Gottlieb T, Gurguí M, Herrera F, Manzur A, Maschmeyer G, Meije Y, Montejo M, Peghin M, Rodríguez-Baño J, Ruiz-Camps I, Sukiennik T C, Carratalà J
Infectious Diseases Department, Bellvitge University Hospital, IDIBELL, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.
Duran i Reynals Hospital, ICO, L'Hospitalet de Llobregat, Barcelona, Spain.
BMJ Open. 2017 Jan 23;7(1):e013268. doi: 10.1136/bmjopen-2016-013268.
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).
由产超广谱β-内酰胺酶革兰氏阴性杆菌（ESBL-GNB）引起的血流感染（BSI）在全球范围内正以惊人的速度增加。尽管对于普通人群中由这些耐药菌引起的BSI，β-内酰胺/β-内酰胺酶抑制剂（BLBLI）联合用药已被建议作为碳青霉烯类药物的替代治疗方案，但其对血液系统中性粒细胞减少患者中由ESBL-GNB引起的BSI的治疗效果仍有待阐明。BICAR研究的目的是比较BLBLI联合用药与碳青霉烯类药物对该人群中由ESBL-GNB引起的BSI的治疗效果。
一项跨国、多中心、观察性回顾性研究。将分析2006年1月1日至2015年3月31日期间血液系统患者和造血干细胞移植受者中发生的由ESBL-GNB引起的BSI病例。主要终点将是BSI发病后30天内的病死率。次要终点将包括7天和14天病死率、微生物学治疗失败、耐药菌定植/感染、二重感染、入住重症监护病房及不良事件的发生情况。
参与中心预计由ESBL-GNB引起的BSI病例数为260例，对照与试验参与者的比例为2。
该研究方案已在首个研究地点获得贝尔维特大学医院研究伦理委员会（REC）的批准。也将寻求所有相关REC的批准。本研究任何正式的数据展示或发表都将被视为参与研究的调查人员的联合发表，并将遵循国际医学期刊编辑委员会（ICMJE）的建议。该研究已得到欧洲血流感染与脓毒症研究组（ESGBIS）和欧洲免疫低下宿主感染研究组（ESGICH）的认可。
