基于快速多重聚合酶链反应的血培养鉴定及药敏试验的随机试验
Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing.
作者信息
Banerjee Ritu, Teng Christine B, Cunningham Scott A, Ihde Sherry M, Steckelberg James M, Moriarty James P, Shah Nilay D, Mandrekar Jayawant N, Patel Robin
机构信息
Division of Pediatric Infectious Diseases, Mayo Clinic, Rochester, Minnesota.
Department of Pharmacy, National University of Singapore and Tan Tock Seng Hospital, Singapore.
出版信息
Clin Infect Dis. 2015 Oct 1;61(7):1071-80. doi: 10.1093/cid/civ447. Epub 2015 Jul 20.
BACKGROUND
The value of rapid, panel-based molecular diagnostics for positive blood culture bottles (BCBs) has not been rigorously assessed. We performed a prospective randomized controlled trial evaluating outcomes associated with rapid multiplex PCR (rmPCR) detection of bacteria, fungi, and resistance genes directly from positive BCBs.
METHODS
A total of 617 patients with positive BCBs underwent stratified randomization into 3 arms: standard BCB processing (control, n = 207), rmPCR reported with templated comments (rmPCR, n = 198), or rmPCR reported with templated comments and real-time audit and feedback of antimicrobial orders by an antimicrobial stewardship team (rmPCR/AS, n = 212). The primary outcome was antimicrobial therapy duration. Secondary outcomes were time to antimicrobial de-escalation or escalation, length of stay (LOS), mortality, and cost.
RESULTS
Time from BCB Gram stain to microorganism identification was shorter in the intervention group (1.3 hours) vs control (22.3 hours) (P < .001). Compared to the control group, both intervention groups had decreased broad-spectrum piperacillin-tazobactam (control 56 hours, rmPCR 44 hours, rmPCR/AS 45 hours; P = .01) and increased narrow-spectrum β-lactam (control 42 hours, rmPCR 71 hours, rmPCR/AS 85 hours; P = .04) use, and less treatment of contaminants (control 25%, rmPCR 11%, rmPCR/AS 8%; P = .015). Time from Gram stain to appropriate antimicrobial de-escalation or escalation was shortest in the rmPCR/AS group (de-escalation: rmPCR/AS 21 hours, control 34 hours, rmPCR 38 hours, P < .001; escalation: rmPCR/AS 5 hours, control 24 hours, rmPCR 6 hours, P = .04). Groups did not differ in mortality, LOS, or cost.
CONCLUSIONS
rmPCR reported with templated comments reduced treatment of contaminants and use of broad-spectrum antimicrobials. Addition of antimicrobial stewardship enhanced antimicrobial de-escalation.
CLINICAL TRIALS REGISTRATION
NCT01898208.
背景
基于快速检测板的分子诊断技术在阳性血培养瓶（BCB）中的应用价值尚未得到严格评估。我们进行了一项前瞻性随机对照试验，评估直接从阳性BCB中快速多重聚合酶链反应（rmPCR）检测细菌、真菌和耐药基因的相关结果。
方法
共有617例BCB阳性患者被分层随机分为3组：标准BCB处理组（对照组，n = 207）、报告有模板化注释的rmPCR组（rmPCR组，n = 198）或报告有模板化注释且由抗菌药物管理团队进行抗菌药物医嘱实时审核与反馈的rmPCR组（rmPCR/AS组，n = 212）。主要结局指标是抗菌治疗持续时间。次要结局指标是抗菌药物降阶梯或升阶梯的时间、住院时间（LOS）、死亡率和成本。
结果
干预组从BCB革兰氏染色到微生物鉴定的时间（1.3小时）比对照组（22.3小时）短（P <.001）。与对照组相比，两个干预组的广谱哌拉西林 - 他唑巴坦使用量均减少（对照组56小时，rmPCR组44小时，rmPCR/AS组45小时；P =.01），窄谱β - 内酰胺类药物使用量增加（对照组42小时，rmPCR组71小时，rmPCR/AS组85小时；P =.04），且对污染物的治疗减少（对照组25%，rmPCR组11%，rmPCR/AS组8%；P =.015）。从革兰氏染色到适当的抗菌药物降阶梯或升阶梯的时间在rmPCR/AS组最短（降阶梯：rmPCR/AS组21小时，对照组34小时，rmPCR组38小时，P <.001；升阶梯：rmPCR/AS组5小时，对照组24小时，rmPCR组6小时，P =.04）。各组在死亡率、LOS或成本方面无差异。
结论
报告有模板化注释的rmPCR减少了对污染物的治疗和广谱抗菌药物的使用。增加抗菌药物管理可增强抗菌药物降阶梯。
临床试验注册
NCT01898208。
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