Clinical trial NCT03391076: The Clinical Value of FA in AHLRI Patients
Official title: The Clinical Value of FilmArray Rapid Viral Testing in Acute Hospitalized Lower Respiratory Infection Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Respiratory Tract Infection
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: BioMérieux
First posted: 2018-01-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The length (days) of antibiotics therapy in hospital between two groups.
timeFrame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary outcomes:
measure: Antibiotics therapy cost
timeFrame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
measure: Length of hospital stay (LOS) and/or ICU stay
timeFrame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
measure: The correlation between the initial serum PCT level and clinical outcomes/mortality
timeFrame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
measure: The detection rate of viruses and atypical pathogens by FilmArray in LRTI patients
timeFrame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chian Japan Friendship Hospital
state: Beijing
Study officials:
References:
citation: Shengchen D, Gu X, Fan G, Sun R, Wang Y, Yu D, Li H, Zhou F, Xiong Z, Lu B, Zhu G, Cao B. Evaluation of a molecular point-of-care testing for viral and atypical pathogens on intravenous antibiotic duration in hospitalized adults with lower respiratory tract infection: a randomized clinical trial. Clin Microbiol Infect. 2019 Nov;25(11):1415-1421. doi: 10.1016/j.cmi.2019.06.012. Epub 2019 Jun 20.