随机试验评估革兰氏阴性菌血培养快速鉴定和药敏检测的临床影响：RAPIDS-GN。
Randomized Trial Evaluating Clinical Impact of RAPid IDentification and Susceptibility Testing for Gram-negative Bacteremia: RAPIDS-GN.
机构信息
Division of Pediatric Infectious Diseases, Vanderbilt University, Nashville, Tennessee, USA.
Biostatistics Center, George Washington University, Rockville, Maryland, USA.
出版信息
Clin Infect Dis. 2021 Jul 1;73(1):e39-e46. doi: 10.1093/cid/ciaa528.
BACKGROUND
Rapid blood culture diagnostics are of unclear benefit for patients with gram-negative bacilli (GNB) bloodstream infections (BSIs). We conducted a multicenter, randomized, controlled trial comparing outcomes of patients with GNB BSIs who had blood culture testing with standard-of-care (SOC) culture and antimicrobial susceptibility testing (AST) vs rapid organism identification (ID) and phenotypic AST using the Accelerate Pheno System (RAPID).
METHODS
Patients with positive blood cultures with Gram stains showing GNB were randomized to SOC testing with antimicrobial stewardship (AS) review or RAPID with AS. The primary outcome was time to first antibiotic modification within 72 hours of randomization.
RESULTS
Of 500 randomized patients, 448 were included (226 SOC, 222 RAPID). Mean (standard deviation) time to results was faster for RAPID than SOC for organism ID (2.7 [1.2] vs 11.7 [10.5] hours; P < .001) and AST (13.5 [56] vs 44.9 [12.1] hours; P < .001). Median (interquartile range [IQR]) time to first antibiotic modification was faster in the RAPID arm vs the SOC arm for overall antibiotics (8.6 [2.6-27.6] vs 14.9 [3.3-41.1] hours; P = .02) and gram-negative antibiotics (17.3 [4.9-72] vs 42.1 [10.1-72] hours; P < .001). Median (IQR) time to antibiotic escalation was faster in the RAPID arm vs the SOC arm for antimicrobial-resistant BSIs (18.4 [5.8-72] vs 61.7 [30.4-72] hours; P = .01). There were no differences between the arms in patient outcomes.
CONCLUSIONS
Rapid organism ID and phenotypic AST led to faster changes in antibiotic therapy for gram-negative BSIs.
CLINICAL TRIALS REGISTRATION
NCT03218397.
背景
革兰氏阴性菌（GNB）血流感染（BSI）患者进行快速血培养诊断的获益尚不清楚。我们进行了一项多中心、随机、对照试验，比较了革兰氏染色显示 GNB 阳性血培养患者进行标准护理（SOC）培养和抗菌药物敏感性检测（AST）与使用 Accelerate Pheno 系统（RAPID）进行快速病原体鉴定（ID）和表型 AST 的治疗结局。
方法
革兰氏染色显示 GNB 阳性的血培养阳性患者被随机分配接受 SOC 检测和抗菌药物管理（AS）审查或 RAPID 检测和 AS。主要结局是随机分组后 72 小时内首次抗生素调整的时间。
结果
在 500 名随机患者中，448 名患者纳入分析（SOC 组 226 例，RAPID 组 222 例）。与 SOC 相比，RAPID 用于病原体 ID（2.7[1.2] 小时 vs 11.7[10.5] 小时；P<0.001）和 AST（13.5[56] 小时 vs 44.9[12.1] 小时；P<0.001）的结果更快。RAPID 组与 SOC 组相比，总体抗生素（8.6[2.6-27.6] 小时 vs 14.9[3.3-41.1] 小时；P=0.02）和革兰氏阴性抗生素（17.3[4.9-72] 小时 vs 42.1[10.1-72] 小时；P<0.001）首次抗生素调整的中位（四分位距[IQR]）时间更快。在耐药性 BSI 中，RAPID 组与 SOC 组相比，抗生素升级的中位（IQR）时间更快（18.4[5.8-72] 小时 vs 61.7[30.4-72] 小时；P=0.01）。两组患者结局无差异。
结论
快速病原体 ID 和表型 AST 导致革兰氏阴性 BSI 抗生素治疗的更快改变。
临床试验注册
NCT03218397。
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