评价一种针对病毒和非典型病原体的分子即时检测技术对住院下呼吸道感染成年患者静脉用抗生素疗程的影响：一项随机临床试验。
Evaluation of a molecular point-of-care testing for viral and atypical pathogens on intravenous antibiotic duration in hospitalized adults with lower respiratory tract infection: a randomized clinical trial.
机构信息
Xuanwu Hospital of Capital Medical University, Beijing, China; Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China; Department of Pulmonary and Critical Care Medicine, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
Department of Institute of Clinical Medical Sciences, China-Japan Friendship Hospital, Beijing, China; Institute of Respiratory Medicine, Chinese Academy of Medical Science, Beijing, China; National Clinical Research Centre of Respiratory Diseases, Beijing, China.
出版信息
Clin Microbiol Infect. 2019 Nov;25(11):1415-1421. doi: 10.1016/j.cmi.2019.06.012. Epub 2019 Jun 20.
OBJECTIVES
The primary objective was to evaluate whether a molecular point-of-care test (POCT) for viral and atypical pathogens added to routine real-time PCR could reduce duration of intravenous antibiotics in hospitalized patients with lower respiratory tract infection (LRTI) compared with routine real-time PCR.
METHODS
In this single-centre, open-label, randomized controlled study, we enrolled hospitalized adults diagnosed with LRTI. Patients were randomized to an intervention group (POCT FilmArray Panel for 20 viruses, atypical pathogens and bacteria plus routine real-time PCR) or a control group (routine real-time PCR for ten pathogens). The primary outcome was duration of intravenous antibiotics during hospitalization. The secondary outcomes included length of stay, cost of hospitalization and de-escalation within 72 hours and between 72 hours and 7 days. Intention-to-treat analysis was used.
RESULTS
Between October 2017 and July 2018, we enrolled 800 eligible patients (398 in the intervention group and 402 in the control group). Duration of intravenous antibiotics in the intervention group was shorter than in the control (7.0 days (interquartile range (IQR) 5.0-9.0) versus 8.0 days (IQR 6.0-11.0); p <0.001). Length of hospital stay in the intervention group was significantly shorter (8.0 days (IQR 7.0-11.0) versus 9.0 days (IQR 7.0-12.0; p <0.001) and the cost of hospitalization in the intervention group was significantly lower ($1804.7 (IQR 1298.4-2633.8) versus $2042.5 (IQR 1427.4-2926.2); p 0.002) than control group. More patients in the intervention group achieved de-escalation within 72 hours (7.9%, 29/367 versus 3.2%, 12/377; p 0.005) and between 72 hours and 7 days (29.7%, 109/367 versus 22.0%, 83/377; p 0.024).
CONCLUSIONS
Use of molecular POCT testing for respiratory viruses and atypical pathogens might help to reduce intravenous antibiotic use in hospitalized LRTI patients.
CLINICAL TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT03391076.
目的
本研究旨在评估与常规实时聚合酶链反应（PCR）相比，用于病毒和非典型病原体的分子即时检测（POCT）是否可以减少住院下呼吸道感染（LRTI）患者的静脉用抗生素治疗时间。
方法
这是一项单中心、开放标签、随机对照研究，纳入了诊断为 LRTI 的住院成人患者。患者被随机分为干预组（POCT FilmArray Panel 用于检测 20 种病毒、非典型病原体和细菌，加常规实时 PCR）或对照组（常规实时 PCR 用于检测 10 种病原体）。主要结局是住院期间静脉用抗生素的持续时间。次要结局包括住院时间、住院费用、72 小时内和 72 小时至 7 天内的降级情况。采用意向治疗分析。
结果
在 2017 年 10 月至 2018 年 7 月期间，我们共纳入了 800 名符合条件的患者（干预组 398 例，对照组 402 例）。干预组的静脉用抗生素治疗时间短于对照组（7.0 天（四分位距 5.0-9.0）与 8.0 天（四分位距 6.0-11.0）；p<0.001）。干预组的住院时间明显缩短（8.0 天（四分位距 7.0-11.0）与 9.0 天（四分位距 7.0-12.0；p<0.001），且住院费用明显降低（1804.7 美元（四分位距 1298.4-2633.8）与 2042.5 美元（四分位距 1427.4-2926.2）；p<0.001）。干预组在 72 小时内（7.9%，29/367 与 3.2%，12/377；p=0.005）和 72 小时至 7 天内（29.7%，109/367 与 22.0%，83/377；p=0.024）实现降级的患者比例明显高于对照组。
结论
使用呼吸道病毒和非典型病原体的分子 POCT 检测可能有助于减少住院 LRTI 患者的静脉用抗生素治疗。
临床试验注册
clinicaltrials.gov 标识符：NCT03391076。
Zotero 插件