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临床试验/NCT01266863
NCT01266863已完成不适用

E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.

Université Victor Segalen Bordeaux 22 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Major error defined as the MIC(s) classified as R or I by E test method and S by referent method

研究概览

简要总结

To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • all patients with suspected HAP undergoing BAL will be eligible

排除标准

  • contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.

结局指标

主要结局

Major error defined as the MIC(s) classified as R or I by E test method and S by referent method

时间窗: 2 days

次要结局

  • Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method(2 days)

研究者

发起方
Université Victor Segalen Bordeaux 2
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Boyer

Medical doctor

Université Victor Segalen Bordeaux 2

研究点 (2)

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