The Clinical Value of FA in AHLRI Patients

Lower Respiratory Tract Infection Clinical Trial

— FALRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391076
• Other study ID #: 20170909
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: October 23, 2018

Study information

• Verified date: October 2018
• Source: Capital Medical University
• Contact: Shengchen DUAN, doctor
• Phone: 13488779977
• Email: doctordsc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 23, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Lower Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• FilmArray Respiratory Panel
An Multi-PCR method which can detect 20 pathogens in 45 minutes.

Locations

Country	Name	City	State
China	Chian Japan Friendship Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Bin Cao	BioMérieux

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antibiotics therapy cost		From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary	Length of hospital stay (LOS) and/or ICU stay		From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary	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
Secondary	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