Bergin Stephen P, Calvert Sara B, Farley John, Sun Jie-Lena, Chiswell Karen, Dieperink Willem, Kluytmans Jan, Lopez-Delgado Juan Carlos, Leon-Lopez Rafael, Zervos Marcus J, Kollef Marin H, Sims Matthew, Kabchi Badih A, Rubin Daniel, Santiago Jonas, Natarajan Mukil, Tenaerts Pamela, Fowler Vance G, Holland Thomas L, Bonten Marc J, Hullegie Sebastiaan J
Duke University, Durham, North Carolina, USA.
Clinical Trials Transformation Initiative, Durham, North Carolina, USA.
Open Forum Infect Dis. 2022 May 9;9(7):ofac231. doi: 10.1093/ofid/ofac231. eCollection 2022 Jul.
The prospective identification of patients at high risk for hospital-acquired/ventilator-associated bacterial pneumonia may improve clinical trial feasibility and foster antibacterial development. In a prior study conducted in the United States, clinical criteria were used to prospectively identify these patients; however, these criteria have not been applied in a European population.
Adults considered high risk for pneumonia (treatment with ventilation or high levels of supplemental oxygen) in the intensive care units of 7 European hospitals were prospectively enrolled from June 12 to December 27, 2017. We estimated the proportion of high-risk patients developing pneumonia according to US Food and Drug Administration guidance and a subset potentially eligible for antibacterial trial enrollment. We compared patient characteristics, treatment exposures, and pneumonia incidence in a European cohort and a previously described US cohort.
Of 888 high-risk patients, 211/888 (24%) were treated for possible pneumonia, and 150/888 (17%) met the Food and Drug Administration definition for hospital-acquired/ventilator-associated bacterial pneumonia. A higher proportion of European patients treated for possible pneumonia met the pneumonia definition (150/211 [71%] vs 537/1464 [37%]; < .001). Among patients developing pneumonia, a higher proportion of European patients met antibacterial trial eligibility criteria (124/150 [83%] vs 371/537 [69%]; < .001).
Clinical criteria prospectively identified high-risk patients with high rates of pneumonia in the European cohort. Despite higher rates of established risk factors and incident pneumonia, European patients were significantly less likely to receive antibiotics for possible pneumonia than US patients. Different treatment practices may contribute to lower rates of antibacterial trial enrollment in the United States.
前瞻性识别医院获得性/呼吸机相关性细菌性肺炎的高危患者可能会提高临床试验的可行性，并促进抗菌药物的研发。在美国进行的一项先前研究中，使用临床标准前瞻性地识别这些患者；然而，这些标准尚未应用于欧洲人群。
2017年6月12日至12月27日，对欧洲7家医院重症监护病房中被认为有肺炎高危风险（接受通气治疗或高浓度补充氧气）的成人进行前瞻性纳入研究。我们根据美国食品药品监督管理局的指南，估计了发生肺炎的高危患者比例以及一部分可能符合抗菌药物试验纳入标准的患者。我们比较了欧洲队列和先前描述的美国队列中的患者特征、治疗暴露情况和肺炎发病率。
在888例高危患者中，211/888（24%）接受了可能肺炎的治疗，150/888（17%）符合美国食品药品监督管理局关于医院获得性/呼吸机相关性细菌性肺炎的定义。接受可能肺炎治疗的欧洲患者中，符合肺炎定义的比例更高（150/211 [71%] 对537/1464 [37%]；P<0.001）。在发生肺炎的患者中，欧洲患者符合抗菌药物试验纳入标准的比例更高（124/150 [83%] 对371/537 [69%]；P<0.001）。
临床标准前瞻性地识别出欧洲队列中肺炎发生率较高的高危患者。尽管既定风险因素和肺炎发病率较高，但欧洲患者因可能肺炎接受抗生素治疗的可能性明显低于美国患者。不同的治疗方式可能导致美国抗菌药物试验纳入率较低。
