The Clinical Value of FilmArray Rapid Viral Testing in Acute Hospitalized Lower Respiratory Infection Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- The length (days) of antibiotics therapy in hospital between two groups.
研究概览
简要总结
LRTI (Lower respiratory tract infection) is a severe disease in China. The fast and accurate diagnosis of pathogens, bacteria or viruses that cause the infection is critical for the therapy. In this study, investigators assume that the use of FilmArray Respiratory Panel will provide more rapid and comprehensive evidences to physicians to diagnose LRTI which is caused by viruses or atypical pathogens and then reduce the length of antibiotics use by 0.5-1.0 days as well as other hospital resources (length of hospital/ICU stay, take-away oral antibiotics, etc.). Secondly, investigators assume that in LRTI patients with viral infection and a low serum PCT level, fewer length of antibiotics use can be expected. Thirdly, the use of FilmArray Respiratory Panel will provide clearer epidemiology data of virus and atypical pathogens in hospitalized LRTI patients.
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
- Single (Participant)
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
- •Adults age >= 18 years old
- •Community acquired Pneumonia, acute exacerbation of chronic obstructive pulmonary disease [AECOPD], acute exacerbation of bronchiectasis.
- •Hospitalization required
- •Informed Consent Form signed
排除标准
- •Age < 18 years old
- •Hospital acquired Pneumonia
- •Patients with lung tuberculosis
- •Pregnant women
- •Patients with immunodeficiency
- •Any conditions which may increase PCT levels
- •Informed Consent Form not signed
研究组 & 干预措施
FilmArray group
Patients in this group will use FilmArray Respiratory Panel to test potential viral pathogens.
干预措施: FilmArray Respiratory Panel (Diagnostic Test)
Routine test group
Patients in this group will use clinical routine methods to test potential viral pathogens.
结局指标
主要结局
The length (days) of antibiotics therapy in hospital between two groups.
时间窗: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
The duration of antibiotics used is defined as days of intravenous antibiotic therapy in which any doses of antibiotics are administered.
次要结局
- Antibiotics therapy cost(From in-hospital to discharge or death, whichever came first, assessed up to 12 months)
- Length of hospital stay (LOS) and/or ICU stay(From in-hospital to discharge or death, whichever came first, assessed up to 12 months)
- The correlation between the initial serum PCT level and clinical outcomes/mortality(From in-hospital to discharge or death, whichever came first, assessed up to 12 months)
- The detection rate of viruses and atypical pathogens by FilmArray in LRTI patients(From in-hospital to discharge or death, whichever came first, assessed up to 12 months)
研究者
Bin Cao
Head of Respiratory Department
Capital Medical University