The Clinical Value of FA in AHLRI Patients (FALRI)

Bin Cao

Status: Unknown

Conditions: Lower Respiratory Tract Infection

Treatments: Diagnostic Test: FilmArray Respiratory Panel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03391076

20170909

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

800 participants in 2 patient groups

FilmArray group

Experimental group

Description:

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

Treatment:

Diagnostic Test: FilmArray Respiratory Panel

Routine test group

No Intervention group

Description:

Patients in this group will use clinical routine methods to test potential viral pathogens.