Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing
Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing
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DOI：
10.1093/cid/civ447
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发表时间：
2015-10-01
影响因子：
11.8
通讯作者：
Patel, Robin
中科院分区：
文献类型：
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作者：
Banerjee, Ritu;Teng, Christine B.;Patel, Robin
背景。针对阳性血培养瓶 (BCB) 的快速、基于面板的分子诊断的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，评估与直接从阳性 BCB 中快速多重 PCR (rmPCR) 检测细菌、真菌和抗性基因相关的结果。方法。共有 617 名 BCB 呈阳性的患者接受分层随机分为 3 个组：标准 BCB 处理（对照，n = 207）、报告模板评论的 rmPCR（rmPCR，n = 198）或报告模板评论以及抗菌管理团队实时审核和反馈抗菌命令的 rmPCR（rmPCR/AS，n = 212）。主要结局是抗菌治疗持续时间。次要结局是抗菌药物降级或升级的时间、住院时间 (LOS)、死亡率和费用。结果。干预组（1.3 小时）与对照组（22.3 小时）相比，从 BCB 革兰氏染色到微生物鉴定的时间更短 (P < .001)。与对照组相比，两个干预组均减少了广谱哌拉西林-他唑巴坦（对照 56 小时，rmPCR 44 小时，rmPCR/AS 45 小时；P = .01），增加了窄谱 β-内酰胺（对照 42 小时，rmPCR 71 小时，rmPCR/AS 85 小时；P = .04）的使用，并减少了污染物处理（对照 25%，rmPCR） 11%，rmPCR/AS 8%；P = .015)。 rmPCR/AS 组从革兰氏染色到适当抗菌药物降级或升级的时间最短（降级：rmPCR/AS 21 小时，对照 34 小时，rmPCR 38 小时，P < .001；升级：rmPCR/AS 5 小时，对照 24 小时，rmPCR 6 小时，P = .04）。各组在死亡率、LOS 或成本方面没有差异。结论。 rmPCR 报告的模板评论减少了污染物的处理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的降级。
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 beta-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 broadspectrum antimicrobials. Addition of antimicrobial stewardship enhanced antimicrobial de-escalation.