NCT00308659Unknown不适用
Diagnostic Strategy Evaluation Study of Two Diagnostic Strategies for the Treatment of SCAP : Noninvasive Strategy and Semiinvasive Strategy Including FOB Distal Samplings
适应症
试验速览
- 阶段
- 不适用
- 试验地点
- 2
研究概览
简要总结
Main hypothesis: microbiological diagnossis off severe community acquired pneumonia can be performed by non invasive or semi invasive microbiological tools, semi invasive tools including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB). A microbiological diagnosis could improve antibiotic therapy efficacy and improve patient's outcome.
These Two strategies have never been prospectivally evauated.
- Aim of the study: To evaluate 2 diagnostic strategies: non invasive or semi invasive including protected distal bronchial samplings by the mean of Fiber optic bronchoscopy (FOB)for the care of patients admitted in intensive care for severe community acquired pneumonia and receiving an empirical antibiotic therapy as recommanded by 2001 American thoracic guidelines
- Type of study randomized multicentric controlled open study
详细描述
Type of study randomized multicentric controlled open study
Number of patients: 200 patients (100 patients in each group)admitted in ICU for SCAP
- Number of center : 5
- Clinical strategies under evaluation :
- Group A: semi-invasive strategy: FOB within 24 hours after ICU admission
- Group B: non-invasive strategy: no FOB within 24 hours after ICU admission
- Evaluation criteria:
Main criteria: Changes in initial empirical antibiotic treatment according to microbiological results obtained in each group.
others
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •New radiological infiltrate SCAP clinical diagnosis admitted in ICU Admitted in hospital for less than 24 hours Aged 18 or older Signed informed consent
排除标准
- •Pregnancy Muribond patients Previuos hospitalisation within One month Neutropenia None HIV status
研究者
研究点 (2)
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