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The Clinical Value of FA in AHLRI Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03391076
Acronym
FALRI
Enrollment
800
Registered
2018-01-05
Start date
2017-09-21
Completion date
2018-10-23
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Respiratory Tract Infection

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.

Interventions

DIAGNOSTIC_TESTFilmArray Respiratory Panel

An Multi-PCR method which can detect 20 pathogens in 45 minutes.

Sponsors

BioMérieux
CollaboratorINDUSTRY
Bin Cao
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsThe duration of antibiotics used is defined as days of intravenous antibiotic therapy in which any doses of antibiotics are administered.

Secondary

MeasureTime frame
Antibiotics therapy costFrom in-hospital to discharge or death, whichever came first, assessed up to 12 months
Length of hospital stay (LOS) and/or ICU stayFrom 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/mortalityFrom 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 patientsFrom in-hospital to discharge or death, whichever came first, assessed up to 12 months

Countries

China

Contacts

Primary ContactShengchen DUAN, doctor
doctordsc@163.com13488779977

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026