快速分子血液检测对医院获得性脓毒症抗生素使用的影响：一项随机临床试验。
The effect of a rapid molecular blood test on the use of antibiotics for nosocomial sepsis: a randomized clinical trial.
作者信息
Rodrigues Cristhieni, Siciliano Rinaldo Focaccia, Filho Helio Caiaffa, Charbel Cecília Eugenia, de Carvalho Sarahyba da Silva Luciane, Baiardo Redaelli Martina, de Paula Rosa Passetti Ana Paula, Franco Maria Renata Gomes, Rossi Flávia, Zeigler Rogerio, De Backer Daniel, Franco Rafael Alves, de Almeida Juliano Pinheiro, Rizk Stéphanie Itala, Fukushima Julia Tizue, Landoni Giovanni, Uip David Everson, Hajjar Ludhmila Abrahão, Strabelli Tania Mara Varejão
机构信息
1Infectious Diseases Control, Heart Institute, University of Sao Paulo, São Paulo, Brazil.
2Molecular Biology Division - University of Sao Paulo, São Paulo, Brazil.
出版信息
J Intensive Care. 2019 Jul 22;7:37. doi: 10.1186/s40560-019-0391-3. eCollection 2019.
BACKGROUND
Appropriate use of antimicrobials is essential to improve outcomes in sepsis. The aim of this study was to determine whether the use of a rapid molecular blood test-Septi (SF) reduces the antibiotic consumption through early de-escalation in patients with nosocomial sepsis compared with conventional blood cultures (BCs).
METHODS
This was a prospective, randomized, superiority, controlled trial conducted at Sao Paulo Heart Institute in the period October 2012-May 2016. Adult patients admitted to the hospital for at least 48 h with a diagnosis of nosocomial sepsis underwent microorganism identification by both SF test and BCs. Patients randomized into the intervention group received antibiotic therapy adjustment according to the results of SF. Patients randomized into the control group received standard antibiotic adjustment according to the results of BCs. The primary endpoint was antimicrobial consumption during the first 14 days after randomization.
RESULTS
A total of 200 patients were included (100 in each group). The intention to treat analysis found no significant differences in median antibiotic consumption. In the subgroup of patients with positive SF and blood cultures (19 and 25 respectively), we found a statistically significant reduction in the median antimicrobial consumption which was 1429 (1071-2000) days of therapy (DOT)/1000 patients-day in the intervention group and 1889 (1357-2563) DOT/1000 patients-day in the control group ( = 0.017), in the median time of antimicrobial de-escalation (8 versus 54 h- < 0.001), in the duration of antimicrobial therapy ( = 0.039) and in anti-gram-positive antimicrobial costs ( = 0.002). Microorganism identification was possible in 24.5% of patients (45/184) by SF and 21.2% (39/184) by BC ( = 0.45).
CONCLUSION
This randomized clinical trial showed that the use of a rapid molecular-based pathogen identification test does not reduce the median antibiotic consumption in nosocomial sepsis. However, in patients with positive microbiological tests, the use of Septi reduced antimicrobial consumption through early de-escalation compared to conventional blood cultures. These results were driven by a reduction in the consumption of antimicrobials used for Gram-positive bacteria.
TRIAL REGISTRATION
The trial was registered at ClinicalTrials.gov (NCT01450358) on 12th October 2011.
背景
合理使用抗菌药物对于改善脓毒症的治疗效果至关重要。本研究的目的是确定与传统血培养（BC）相比，使用快速分子血液检测-Septi（SF）是否能通过早期降阶梯治疗减少医院获得性脓毒症患者的抗生素使用量。
方法
这是一项于2012年10月至2016年5月在圣保罗心脏研究所进行的前瞻性、随机、优效性、对照试验。因医院获得性脓毒症入院至少48小时的成年患者，通过SF检测和BC进行微生物鉴定。随机分为干预组的患者根据SF结果调整抗生素治疗。随机分为对照组的患者根据BC结果进行标准抗生素调整。主要终点是随机分组后前14天的抗菌药物使用量。
结果
共纳入200例患者（每组100例）。意向性分析发现中位抗生素使用量无显著差异。在SF和血培养均为阳性的患者亚组中（分别为19例和25例），我们发现干预组的中位抗菌药物使用量有统计学显著降低，为1429（1071 - 2000）治疗日（DOT）/1000患者日，对照组为1889（1357 - 2563）DOT/1000患者日（P = 0.017），抗菌药物降阶梯的中位时间（8小时对54小时 - P < 0.001）、抗菌药物治疗持续时间（P = 0.039）以及抗革兰氏阳性菌抗菌药物成本（P = 0.002）均有差异。通过SF能在24.5%的患者（45/184）中鉴定出微生物，通过BC能在21.2%（39/184）的患者中鉴定出微生物（P = 0.45）。
结论
这项随机临床试验表明，使用基于分子的快速病原体鉴定检测并不能降低医院获得性脓毒症的中位抗生素使用量。然而，在微生物检测呈阳性的患者中，与传统血培养相比，使用Septi通过早期降阶梯治疗减少了抗菌药物使用量。这些结果是由用于革兰氏阳性菌的抗菌药物使用量减少所驱动的。
试验注册
该试验于2011年10月12日在ClinicalTrials.gov（NCT01450358）注册。
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