多重PCR与血清降钙素原联合使用以减少社区获得性肺炎重症患者的抗生素暴露：MULTI-CAP随机对照试验
Combined use of a multiplex PCR and serum procalcitonin to reduce antibiotic exposure in critically ill patients with community-acquired pneumonia: the MULTI-CAP randomized controlled trial.
作者信息
Voiriot Guillaume, Argaud Laurent, Cohen Yves, Tuffet Sophie, Chauvelot Louis, Souweine Bertrand, Klouche Kada, Reignier Jean, Schwebel Carole, Rouzé Anahita, Mekontso Dessap Armand, Bohé Julien, Megarbane Bruno, Carvelli Julien, Navellou Jean-Christophe, Gibot Sébastien, Maury Éric, Dellamonica Jean, Dequin Pierre-François, Dessajan Julien, Armand-Lefèvre Laurence, Vandenesch Francois, Verdet Charlotte, Durand Zaleski Isabelle, Bérard Laurence, Rousseau Alexandra, Tabassome Simon, Fartoukh Muriel, Timsit Jean-François
机构信息
Sorbonne Université, Assistance Publique - Hôpitaux de Paris, Service de Médecine Intensive Réanimation, Hôpital Tenon, GRC SoLID, INSERM Centre de Recherche Saint-Antoine UMRS_938 Team 5PMed, Paris, France.
Service de Médecine Intensive-Réanimation, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France.
出版信息
Intensive Care Med. 2025 Jul 15. doi: 10.1007/s00134-025-08014-9.
PURPOSE
Multiplex polymerase chain reaction (mPCR) testing has the potential to rapidly and accurately identify causative microorganisms in patients with community-acquired pneumonia (CAP). Its use in a management strategy, along with biomarkers, may reduce antibiotic exposure and improve clinical outcomes.
METHODS
The MULTI-CAP trial was a multicenter (n = 20), parallel-group, superiority, open-label, randomized trial. Subjects were non-immunocompromised adult patients (≥ 18 years) admitted to the intensive care unit (ICU) for CAP and randomly assigned in a 1:1 ratio. In the intervention group, the microbiological diagnosis combined a broad-spectrum respiratory mPCR and conventional microbiological investigations. An algorithm for early discontinuation or de-escalation of antibiotics was applied, based on mPCR results and serum procalcitonin. In the control group, only conventional microbiological investigations were performed. In both groups, antibiotic discontinuation was considered on Day 3 and day after day until Day 7, based on procalcitonin values and kinetics. The primary endpoint was defined as the number of days alive without any antibiotic from the time of enrollment to Day 28.
RESULTS
From October 4, 2018, to March 3, 2022, 406 patients were randomized, and 385 were evaluable in the intention-to-treat analysis. The median number of days alive without antibiotics on Day 28 was 19.0 (0.0; 24.0) days in the intervention group and 19.0 (7.0; 22.0) days in the control group (difference, 0.0 (95% CI, - 4.0 to 4.0). However, the antibiotic cumulative duration on day 28 was 3 days shorter (95% CI, - 5.1 to - 0.9) in the intervention group. Serious adverse events did not differ between groups.
CONCLUSION
In ICU patients with CAP, a management strategy combining a mPCR and serum procalcitonin failed to reduce antibiotic exposure or improve outcomes on Day 28, compared to usual care.
TRIAL REGISTRATION NUMBER
NCT03452826 (March 2018), EudraCT 2017-A01615-48.
目的
多重聚合酶链反应（mPCR）检测有潜力快速、准确地识别社区获得性肺炎（CAP）患者的致病微生物。将其与生物标志物一起用于管理策略中，可能会减少抗生素暴露并改善临床结局。
方法
MULTI-CAP试验是一项多中心（n = 20）、平行组、优效性、开放标签的随机试验。受试者为因CAP入住重症监护病房（ICU）的非免疫功能低下成年患者（≥18岁），按1:1比例随机分配。在干预组中，微生物学诊断结合了广谱呼吸道mPCR和传统微生物学检查。基于mPCR结果和血清降钙素原，应用了抗生素早期停用或降阶梯算法。在对照组中，仅进行传统微生物学检查。在两组中，根据降钙素原值和动力学，在第3天及之后直至第7天考虑停用抗生素。主要终点定义为从入组到第28天无任何抗生素使用的存活天数。
结果
从2018年10月4日至2022年3月3日，406例患者被随机分组，385例可纳入意向性分析。在第28天，干预组无抗生素使用的存活天数中位数为19.0（0.0；24.0）天，对照组为19.0（7.0；22.0）天（差异为0.0（95%CI，-4.0至4.0））。然而，干预组在第28天的抗生素累积使用时长缩短了3天（95%CI，-5.1至-0.9）。两组间严重不良事件无差异。
结论
在ICU的CAP患者中，与常规治疗相比，结合mPCR和血清降钙素原的管理策略未能在第28天减少抗生素暴露或改善结局。
试验注册号
NCT03452826（2018年3月），EudraCT 2017-A01615-48。
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