Evaluation of the Incidence of Invasive Pulmonary Aspergillosis in Patients With Suspected Ventilator-associated Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP
研究概览
简要总结
Mechanically ventilated patients are at risk of developing ventilator-associated pneumonia (VAP). Invasive pulmonary aspergillosis (IPA), the diagnosis of which motivates the implementation of specific treatments, is one of the causes of VAP. The hypothesis of the study is that the incidence of IPA is 12.4%. For each patient presenting with a suspicion of VAP and requiring a bronchoalveolar lavage (BAL), the diagnosis of API will be evaluated by biological examinations performed on blood and BAL. Medical and surgical history as well as clinical and biological data will be collected for 28 days or until discharge from the ICU.
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
- •Adult patient (age ≥ 18 years),
- •On invasive ventilation for more than 48 hours,
- •Suspected VAP, defined by the appearance or worsening of a radiological pulmonary infiltrate, associated with 2 of the following clinical criteria:
- •Fever ≥ 38° C or hypothermia ≤ 36.5° C
- •Leukocytes > 12x109 or < 4x109/L
- •Purulent tracheal secretions
排除标准
- •Neutropenic patients (neutrophils < 0.5G/L),
- •Previous diagnosis of IPA,
- •Minor patients.
结局指标
主要结局
Incidence of probable or proven IPA according to the Verweij criteria in patients with suspected VAP
时间窗: On the 1 day of inclusion
次要结局
- Incidence of IPA according to the Blot criteria(On the 1 day of inclusion)
- Incidence of Aspergillus tracheobronchitis associated with IPA according to the Verweij criteria(On the 1 day of inclusion)
- Incidence of IPA according to the Verweij criteria in the subgroup without risk factors.(On the 1 day of inclusion)
- Mortality(at 28 days)
- Length of stay in intensive care unit(Until discharge from the ICU, an average 28 days)
- Duration of mechanical ventilation(Until discharge from the ICU, an average 28 days)