The Clinical Value of FA in AHLRI Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Clinical Value of FilmArray Rapid Viral Testing in Acute Hospitalized Lower Respiratory Infection Patients: A Randomized Controlled Study

Conditions
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Lower Respiratory Tract Infection

Intervention / Treatment
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* Diagnostic Test: FilmArray Respiratory Panel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FilmArray group<br>Patients in this group will use FilmArray Respiratory Panel to test potential viral pathogens. | Diagnostic Test: FilmArray Respiratory Panel<br>* An Multi-PCR method which can detect 20 pathogens in 45 minutes.<br>|
| No Intervention: Routine test group<br>Patients in this group will use clinical routine methods to test potential viral pathogens. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length (days) of antibiotics therapy in hospital between two groups. | The duration of antibiotics used is defined as days of intravenous antibiotic therapy in which any doses of antibiotics are administered. | From in-hospital to discharge or death, whichever came first, assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |