ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 2
- 主要终点
- A 20% reduction of the duration of clinical symptoms of exacerbation is expected
研究概览
简要总结
Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial of mortality in such patients. Although bacterial and or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The absence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.
The primary objective of the essay is to evaluate the effectiveness of the precocious antibiotic therapy on the length of the respiratory symptoms with the admitted patients in polyvalent medical intensive care of chronic obstructive lung disease ( COLD )
详细描述
This is a multicenter, randomised, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ.
排除标准
- •Patients recently hospitalised, having received antibiotics since more than 24h, or on long-term steroids will not be included
研究组 & 干预措施
1
Amoxicillin-clavulanic
干预措施: Amoxicillin-clavulanic (Drug)
结局指标
主要结局
A 20% reduction of the duration of clinical symptoms of exacerbation is expected
时间窗: during de study
A 20% reduction of the duration of clinical symptoms of exacerbation is expected
次要结局
- The incidence of documented infection, antibiotic use, the proportion of patients having infection with resistant bacteria(during the study)