NCT03391076

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Bin Cao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lower Respiratory Tract Infection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FilmArray Respiratory Panel	An Multi-PCR method which can detect 20 pathogens in 45 minutes.

Timeline

• Start date: 2017-09-21
• Primary completion: 2018-09-30
• Completion: 2018-10-23
• First posted: 2018-01-05
• Last updated: 2018-10-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study