The Clinical Value of FA in AHLRI Patients

Not Applicable

• Conditions: Lower Respiratory Tract Infection
• Interventions: Diagnostic Test: FilmArray Respiratory Panel

• Registration Number: NCT03391076
• Lead Sponsor: Bin Cao

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-21
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-05
• Primary Completion: 2018-09-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-07
• Last Update Posted: 2018-10-09
• Study Completion: 2018-10-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FilmArray group	FilmArray Respiratory Panel	Patients in this group will use FilmArray Respiratory Panel to test potential viral pathogens.

Primary Outcome Measures

Name	Time	Method
The length (days) of antibiotics therapy in hospital between two groups.	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Chian Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China