Early-Onset Ventilator-Associated Pneumonia in Adults Randomized Clinical Trial: Comparison of 8 versus 15 Days of Antibiotic Treatment
Early-Onset Ventilator-Associated Pneumonia in Adults Randomized Clinical Trial: Comparison of 8 versus 15 Days of Antibiotic Treatment
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DOI：
10.1371/journal.pone.0041290
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发表时间：
2012-08-31
期刊：
影响因子：
3.7
通讯作者：
Papazian, Laurent
中科院分区：
文献类型：
--
作者：
Capellier, Gilles;Mockly, Helene;Papazian, Laurent
目的：呼吸机相关性肺炎的最佳治疗持续时间是基于一项处理迟发性疾病的研究。缩短抗生素治疗时间仍然是预防多重耐药菌出现的主要因素。目的：证明2种不同的抗生素治疗时间方法：1998年至2002年进行的随机、前瞻性、开放性、多中心试验。主要终点是第21天的临床治愈率。结果：共纳入13个中心的225例患者。191例（84.9%）患者治愈：15天队列中109例中的92例（84.4%）和8天队列中116例中的99例（85.3%）（差异= 0.9%，比值比= 0.929）。差异和比值比的95%双侧置信区间分别为[28.4%~ 10.3%]和[0.448 ~ 1.928]。考虑到等效性限度（差异为10%，比值比为2.25），达到了证明2种治疗持续时间之间等效性的目的。尽管8天队列的继发感染率高于15天队列，但8天队列的抗生素治疗天数仍较低。两组患者第21 ~ 90天的死亡率无差异。结论：抗生素8 d疗程治疗气管插管患者早发呼吸机相关性肺炎是安全的。
Purpose: The optimal treatment duration for ventilator-associated pneumonia is based on one study dealing with late-onset of the condition. Shortening the length of antibiotic treatment remains a major prevention factor for the emergence of multiresistant bacteria.Objective: To demonstrate that 2 different antibiotic treatment durations (8 versus 15 days) are equivalent in terms of clinical cure for early-onset ventilator-associated pneumonia.Methods: Randomized, prospective, open, multicenter trial carried out from 1998 to 2002.Measurements: The primary endpoint was the clinical cure rate at day 21. The mortality rate was evaluated on days 21 and 90.Results: 225 patients were included in 13 centers. 191 (84.9%) patients were cured: 92 out of 109 (84.4%) in the 15 day cohort and 99 out of 116 (85.3%) in the 8 day cohort (difference = 0.9%, odds ratio = 0.929). 95% two-sided confidence intervals for difference and odds ratio were [28.4% to 10.3%] and [0.448 to 1.928] respectively. Taking into account the limits of equivalence (10% for difference and 2.25 for odds ratio), the objective of demonstrative equivalence between the 2 treatment durations was fulfilled. Although the rate of secondary infection was greater in the 8 day than the 15 day cohort, the number of days of antibiotic treatment remained lower in the 8 day cohort. There was no difference in mortality rate between the 2 groups on days 21 and 90.Conclusion: Our results suggest that an 8-day course of antibiotic therapy is safe for early-onset ventilator-associated pneumonia in intubated patients.