Anaesthesiology and Critical Care Medicine, Bichat-Claude Bernard University Hospital, HUPNSV, AP-HP, INSERM, UMR 1152, Paris Diderot Sorbonne Cite University, Paris, France.
Département d'Anesthésie-Réanimation, CHU Bichat Claude Bernard, 48 rue Henri Huchard, 75018, Paris, France.
Intensive Care Med. 2018 Mar;44(3):300-310. doi: 10.1007/s00134-018-5088-x. Epub 2018 Feb 26.
Shortening the duration of antibiotic therapy (ABT) is a key measure in antimicrobial stewardship. The optimal duration of ABT for treatment of postoperative intra-abdominal infections (PIAI) in critically ill patients is unknown.
A multicentre prospective randomised trial conducted in 21 French intensive care units (ICU) between May 2011 and February 2015 compared the efficacy and safety of 8-day versus 15-day antibiotic therapy in critically ill patients with PIAI. Among 410 eligible patients (adequate source control and ABT on day 0), 249 patients were randomly assigned on day 8 to either stop ABT immediately (n = 126) or to continue ABT until day 15 (n = 123). The primary endpoint was the number of antibiotic-free days between randomisation (day 8) and day 28. Secondary outcomes were death, ICU and hospital length of stay, emergence of multidrug-resistant (MDR) bacteria and reoperation rate, with 45-day follow-up.
Patients treated for 8 days had a higher median number of antibiotic-free days than those treated for 15 days (15 [6-20] vs 12 [6-13] days, respectively; P < 0.0001) (Wilcoxon rank difference 4.99 days [95% CI 2.99-6.00; P < 0.0001). Equivalence was established in terms of 45-day mortality (rate difference 0.038, 95% CI - 0.013 to 0.061). Treatments did not differ in terms of ICU and hospital length of stay, emergence of MDR bacteria or reoperation rate, while subsequent drainages between day 8 and day 45 were observed following short-course ABT (P = 0.041).
Short-course antibiotic therapy in critically ill ICU patients with PIAI reduces antibiotic exposure. Continuation of treatment until day 15 is not associated with any clinical benefit. CLINICALTRIALS.
NCT01311765.
缩短抗生素治疗（ABT）的疗程是抗菌药物管理的关键措施。危重患者术后腹腔内感染（PIAI）的最佳 ABT 疗程尚不清楚。
2011 年 5 月至 2015 年 2 月，在 21 家法国重症监护病房（ICU）进行了一项多中心前瞻性随机试验，比较了危重患者 PIAI 中 8 天与 15 天抗生素治疗的疗效和安全性。在 410 名符合条件的患者（充分的源头控制和 ABT 在第 0 天）中，249 名患者在第 8 天随机分为两组，一组立即停止 ABT（n=126），另一组继续 ABT 至第 15 天（n=123）。主要终点是随机分组（第 8 天）至第 28 天之间的无抗生素天数。次要结局包括死亡、ICU 和住院时间、出现多重耐药（MDR）细菌和再手术率，随访 45 天。
接受 8 天治疗的患者比接受 15 天治疗的患者中位无抗生素天数更多（分别为 15 [6-20] 天和 12 [6-13] 天；P<0.0001）（Wilcoxon 秩和检验 4.99 天[95%CI 2.99-6.00；P<0.0001）。在 45 天死亡率方面，等效性成立（率差 0.038，95%CI -0.013 至 0.061）。在 ICU 和住院时间、MDR 细菌出现或再手术率方面，两种治疗方法无差异，而在短疗程 ABT 后（P=0.041），第 8 天至第 45 天之间仍有后续引流。
在危重 ICU 患者中，对 PIAI 采用短疗程抗生素治疗可减少抗生素暴露。延长至第 15 天的治疗与任何临床获益无关。临床试验.gov 标识符：NCT01311765。
