NCT02127528Unknown不适用
Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care: Pharmacodynamic Evaluation and Impact.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- adequate antibiotics
研究概览
简要总结
this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact of these pharmacodynamic parameters on the clinical and microbiological VAP will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use of mechanical ventilation for more than 48 hours
- •Clinical suspicion of ventilation-acquired pneumonia (VAP) defined by new radiological persisting infiltrate (or ARDS) AND one of the following features:
- •purulent tracheal aspirates OR temperature ≥ 38.3°C OR leukocytosis> 10 giga/L
- •High risk of multidrug-resistant bacteria, defined as either at least 6 days of mechanical ventilation OR antibiotic treatment in the previous 15 days
- •Implementation of a prior distal respiratory sample for microbiological diagnosis by bronchoalveolar lavage (BAL) OR distal sampling by protected catheter (PDP)
- •Age ≥ 18 years
- •Implementing a medical examination
- •Obtain the written consent of the patient, one of its relatives or trusted person previously designated or emergency clause.
排除标准
- •Pregnant woman
- •Expected death within 72 hours of diagnosis of VAP patient
- •No affiliation to a social security scheme (beneficiary or legal)
- •Contraindication to one of classes of molecules used antibiotics (β-lactam / Fluoroquinolones / Aminoglycosides), contained in the Summary of Product Characteristics for authorization on the market.
结局指标
主要结局
adequate antibiotics
时间窗: 28 days
proportion of patients for whom the pharmacodynamic target defined a priori according to data from the literature is reached for each antibiotic anti Gram-negative bacillus used empirically activity (including β-lactams, fluoroquinolones and aminoglycosides)
次要结局
- Bacterial species(28 days)
- Number of days alive without mechanical ventilation(28 days)
- Clinical recovery(28 days)
- Score of organ failure (SOFA)(8 days)
- Death(28 days)
- Distribution of the main pharmacodynamic parameters(28 days)
- Eradication of gram negative bacilli responsible for VAP(28 days)
研究者
研究点 (1)
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