Bouglé Adrien, Foucrier Arnaud, Dupont Hervé, Montravers Philippe, Ouattara Alexandre, Kalfon Pierre, Squara Pierre, Simon Tabassome, Amour Julien
Department of Anesthesiology and Critical Care, CHU La Pitié-Salpêtrière, Assistance Publique - Hôpitaux de Paris (APHP), Paris, France.
Department of Anesthesiology and Critical Care, Hôpital Beaujon, APHP, Paris, France.
Trials. 2017 Jan 23;18(1):37. doi: 10.1186/s13063-017-1780-3.
Ventilator-associated pneumonia (VAP) accounts for 25% of infections in intensive care units. Compared to a long duration (LD) of antibiotic therapy, a short duration (SD) has a comparable clinical efficacy with less antibiotic use and less multidrug-resistant (MDR) pathogen emergence, with the exception of documented VAP of non-fermenting Gram-negative bacilli (NF-GNB), including Pseudomonas aeruginosa (PA). These results have led the American Thoracic Society to recommend SD therapy for VAP, except for PA-VAP. Thus the beneficial effect of SD therapy in PA-VAP is still a matter of debate. We aimed to assess the non-inferiority of a short duration of antibiotics (8 days) versus prolonged antibiotic therapy (15 days) in PA-VAP.
METHODS/DESIGN: The impact of the duration of antibiotics on clinical events in patients with Pseudomonas aeruginosa ventilator-associated pneumonia (iDIAPASON) trial is a randomized, open-labeled non-inferiority controlled trial, conducted in 34 French intensive care units (ICUs), comparing two groups of patients with PA-VAP according to the duration (8 days or 15 days) of effective antibiotic therapy against PA. The primary outcome is a composite endpoint combining day 90 mortality and PA-VAP recurrence rate during hospitalization in the ICU. Furthermore, durations of mechanical ventilation and hospitalization, as well as number and types of extrapulmonary infections or acquisition of MDR pathogens during the hospitalization in the ICU will be recorded. Recurrence with predefined criteria (clinical suspicion of VAP associated with a positive quantitative culture of a respiratory sample) will be evaluated by two independent experts.
Demonstrating that an SD (8 days) versus LD (15 days) therapy strategy in PA-VAP treatment is safe and not associated with an increased mortality or recurrence rate could lead to a change in practices and guidelines in the management of antibiotic therapy of this frequent ICU complication. This strategy could lead to decreased antibiotic exposure during hospitalization in the ICU and in turn reduce the acquisition and the spread of MDR pathogens.
ClinicalTrials.gov: NCT02634411 . Registered on 19 November 2015.
呼吸机相关性肺炎（VAP）占重症监护病房感染的25%。与长时间（LD）抗生素治疗相比，短时间（SD）治疗具有相当的临床疗效，且抗生素使用量更少，多重耐药（MDR）病原体出现的情况也更少，但已确诊的非发酵革兰氏阴性杆菌（NF-GNB）引起的VAP除外，其中包括铜绿假单胞菌（PA）。这些结果促使美国胸科学会建议对VAP采用短疗程治疗，但PA-VAP除外。因此，短疗程治疗在PA-VAP中的有益效果仍存在争议。我们旨在评估短疗程抗生素（8天）与延长抗生素治疗（15天）在PA-VAP治疗中的非劣效性。
方法/设计：抗生素疗程对铜绿假单胞菌呼吸机相关性肺炎患者临床事件的影响（iDIAPASON）试验是一项随机、开放标签的非劣效性对照试验，在34个法国重症监护病房（ICU）进行，根据针对PA的有效抗生素治疗疗程（8天或15天）将两组PA-VAP患者进行比较。主要结局是一个综合终点，包括第90天死亡率和ICU住院期间PA-VAP复发率。此外，还将记录机械通气和住院时间，以及ICU住院期间肺外感染的数量和类型或MDR病原体的获得情况。两名独立专家将根据预定义标准（临床怀疑VAP且呼吸道样本定量培养呈阳性）评估复发情况。
证明PA-VAP治疗中短疗程（8天）与长疗程（15天）治疗策略是安全的，且与死亡率或复发率增加无关，可能会导致这种常见ICU并发症抗生素治疗管理的实践和指南发生变化。该策略可能会减少ICU住院期间的抗生素暴露，进而减少MDR病原体的获得和传播。
ClinicalTrials.gov：NCT02634411。于2015年11月19日注册。
