DNA-based Testing in BAL of Lung Transplant Recipients With Suspected Non-viral Lower Respiratory Tract Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 主要终点
- Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection
研究概览
简要总结
Lung transplantation (LTx) , DNA-based testing.
Performance of DNA-based testing of bacterial and fungal pathogens in comparison to standard testing.
Experimental intervention: DNA-based testing of BAL fluid.
详细描述
Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection.
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
- •patients after lung transplantation (single, double or combined)
- •suspicion of non-viral lower respiratory tract infection as defined by at least 2 out of
- •new onset of malaise
- •new or progressive pulmonary infiltrate
- •hypoxemia (SpO2/SaO2 <92% or need for oxygen)
- •temperature of 38 o C or above within 7 days
- •purulent (yellow or greenish) sputum
- •CRP of 30 mg/l or above
- •PCT of 0,5 µg/l or above
排除标准
- •no informed consent
结局指标
主要结局
Cohen's kappa of any pathogen isolation by DNA-based testing vs. standard cultures in comparison to the final diagnosis of non-viral lower respiratory tract infection
时间窗: 6 month
Cohen's kappa measures the agreement between methods and the final clinical diagnosis. Both methods (DNA-based testing and standard cultures) will result in isolation of a non-viral pathogen or no isolation of a pathogen. A final clinical diagnosis will classify patients clinically in two categories as non-viral lower respiratory tract infection or no non-viral lower respiratory tract infection usually made 48-72 hours made after sampling. Cohen's kappa will be compared between the two methods.
次要结局
未报告次要终点
研究者
Thomas Fuehner
PD Dr. med. Thomas Fühner
Hannover Medical School