Álvarez-Moreno Carlos Arturo, Nocua-Báez Laura Cristina, Ortiz Guillermo, Torres Juan Carlos, Montenegro Gabriel, Cervera Williams, Zuluaga Luis Fernando, Gómez Alonso
Department of Internal Medicine, Infectious Diseases, Universidad Nacional de Colombia, Bogotá 111321, Colombia.
Santa Clara Hospital, Bogotá 111711, Colombia.
Antibiotics (Basel). 2024 Feb 29;13(3):229. doi: 10.3390/antibiotics13030229.
The objective of this study was to compare the continuous infusion of cefepime with the intermittent infusion in patients with sepsis caused by Gram-negative bacilli (GNB).
Randomized 1:1 multicenter double-blinded placebo-controlled study with allocation concealment; multicenter study in the intensive care units of Colombia. Patients with sepsis, severe sepsis or septic shock, and GNB-suspected bacteremia. Cefepime was administered for 7 to 14 days over 30 m intermittently every 8 h over 24 h plus continuous saline solution (0.9%) (G1) or 3 g administered continuously plus saline solution every 8 h (0.9%) (G2). The percentage of clinical response at 3, 7, and 14 days, relapse at 28 days, and mortality at discharge were measured.
The recruitment was stopped at the suggestion of the Institutional Review Board (IRB) following an FDA alert about cefepime. Thirty-two patients were randomized; 25 received the intervention, and GNB bacteremia was confirmed in 16 (9 G1 and 7 G2). Favorable clinical response in days 3, 7, and 14 was 88.8%, 88.8%, and 77.8% (G1) and was similar for G2 (85.7%). There were no relapses or deaths in G2, while in G1, one relapse and two deaths were observed.
The results of this study support the use of cefepime for the treatment of Gram-negative infections in critically ill patients, but we could not demonstrate differences between continuous or intermittent administration because of the small sample size, given the early suspension of the study.
本研究的目的是比较头孢吡肟持续输注与间歇输注在革兰氏阴性杆菌（GNB）所致脓毒症患者中的疗效。
采用1:1随机多中心双盲安慰剂对照研究，实施分配隐藏；在哥伦比亚的重症监护病房进行多中心研究。纳入脓毒症、严重脓毒症或脓毒性休克且怀疑GNB菌血症的患者。头孢吡肟给药7至14天，G1组为每24小时每8小时间歇输注30分钟共3克，加持续生理盐水（0.9%）；G2组为持续输注3克，每8小时加生理盐水（0.9%）。测定第3、7和14天的临床反应百分比、第28天的复发率和出院时的死亡率。
在美国食品药品监督管理局（FDA）对头孢吡肟发出警报后，根据机构审查委员会（IRB）的建议停止招募。32例患者被随机分组；25例接受干预，16例确诊为GNB菌血症（9例G1组和7例G2组）。G1组第3、7和14天的良好临床反应率分别为88.8%、88.8%和77.8%，G2组相似（85.7%）。G2组无复发或死亡，而G1组观察到1例复发和2例死亡。
本研究结果支持使用头孢吡肟治疗重症患者的革兰氏阴性感染，但由于样本量小且研究提前中止，我们未能证明持续给药或间歇给药之间的差异。
