Levitt Joseph E, Festic Emir, Desai Manisha, Hedlin Haley, Mahaffey Kenneth W, Rogers Angela J, Gajic Ognjen, Matthay Michael A
Division of Pulmonary, Allergy and Critical Care Medicine.
Division of Pulmonary Medicine and.
Ann Am Thorac Soc. 2021 Apr;18(4):698-708. doi: 10.1513/AnnalsATS.202009-1115SD.
Patients hospitalized for pneumonia are at high risk for mortality. Effective therapies are therefore needed. Recent randomized clinical trials suggest that systemic steroids can reduce the length of hospital stays among patients hospitalized for pneumonia. Furthermore, preliminary findings from a feasibility study demonstrated that early treatment with a combination of an inhaled corticosteroid and a bronchodilator can improve oxygenation and reduce risk of respiratory failure in patients at risk of acute respiratory distress syndrome. Whether such a combination administered early is effective in reducing acute respiratory failure (ARF) among patients hospitalized with pneumonia is unknown. Here we describe the ARREST Pneumonia (Arrest Respiratory Failure due to Pneumonia) trial designed to address this question. ARREST Pneumonia is a two-arm, randomized, double-blinded, placebo-controlled trial designed to test the efficacy of a combination of an inhaled corticosteroid and a β-agonist compared with placebo for the prevention of ARF in hospitalized participants with severe pneumonia. The primary outcome is ARF within 7 days of randomization, defined as a composite endpoint of intubation and mechanical ventilation; need for high-flow nasal cannula oxygen therapy or noninvasive ventilation for >36 hours (each alone or combined); or death within 36 hours of being placed on respiratory support. The planned enrollment is 600 adult participants at 10 academic medical centers. In addition, we will measure selected plasma biomarkers to better understand mechanisms of action. The trial is funded by the U.S. National Heart Lung and Blood Institute.Clinical trial registered with www.clinicaltrials.gov (NCT04193878).
因肺炎住院的患者死亡风险很高。因此需要有效的治疗方法。最近的随机临床试验表明，全身用类固醇可以缩短因肺炎住院患者的住院时间。此外，一项可行性研究的初步结果表明，吸入性皮质类固醇和支气管扩张剂联合早期治疗可改善急性呼吸窘迫综合征高危患者的氧合情况并降低呼吸衰竭风险。这种联合早期给药对降低肺炎住院患者的急性呼吸衰竭（ARF）是否有效尚不清楚。在此，我们描述了旨在解决这一问题的ARREST肺炎（因肺炎导致的呼吸衰竭）试验。ARREST肺炎试验是一项双臂、随机、双盲、安慰剂对照试验，旨在测试吸入性皮质类固醇和β受体激动剂联合使用与安慰剂相比，对预防重症肺炎住院参与者发生ARF的疗效。主要结局是随机分组后7天内的ARF，定义为插管和机械通气的复合终点；需要高流量鼻导管吸氧治疗或无创通气超过36小时（单独或联合使用）；或在接受呼吸支持后36小时内死亡。计划在10个学术医学中心招募600名成年参与者。此外，我们将测量选定的血浆生物标志物，以更好地了解作用机制。该试验由美国国立心肺血液研究所资助。临床试验已在www.clinicaltrials.gov注册（NCT04193878）。
