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The Clinical Value of FA in AHLRI Patients (FALRI)

Primary Purpose

Lower Respiratory Tract Infection

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FilmArray Respiratory Panel
Sponsored by
Bin Cao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Respiratory Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chian Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

FilmArray group

Routine test group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Antibiotics therapy cost
Length of hospital stay (LOS) and/or ICU stay
The correlation between the initial serum PCT level and clinical outcomes/mortality
The detection rate of viruses and atypical pathogens by FilmArray in LRTI patients

Full Information

First Posted
December 7, 2017
Last Updated
October 7, 2018
Sponsor
Bin Cao
Collaborators
BioMérieux
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1. Study Identification

Unique Protocol Identification Number
NCT03391076
Brief Title
The Clinical Value of FA in AHLRI Patients
Acronym
FALRI
Official Title
The Clinical Value of FilmArray Rapid Viral Testing in Acute Hospitalized Lower Respiratory Infection Patients: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
September 30, 2018 (Anticipated)
Study Completion Date
October 23, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bin Cao
Collaborators
BioMérieux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Respiratory Tract Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FilmArray group
Arm Type
Experimental
Arm Description
Patients in this group will use FilmArray Respiratory Panel to test potential viral pathogens.
Arm Title
Routine test group
Arm Type
No Intervention
Arm Description
Patients in this group will use clinical routine methods to test potential viral pathogens.
Intervention Type
Diagnostic Test
Intervention Name(s)
FilmArray Respiratory Panel
Intervention Description
An Multi-PCR method which can detect 20 pathogens in 45 minutes.
Primary Outcome Measure Information:
Title
The length (days) of antibiotics therapy in hospital between two groups.
Description
The duration of antibiotics used is defined as days of intravenous antibiotic therapy in which any doses of antibiotics are administered.
Time Frame
From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Secondary Outcome Measure Information:
Title
Antibiotics therapy cost
Time Frame
From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Title
Length of hospital stay (LOS) and/or ICU stay
Time Frame
From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Title
The correlation between the initial serum PCT level and clinical outcomes/mortality
Time Frame
From in-hospital to discharge or death, whichever came first, assessed up to 12 months
Title
The detection rate of viruses and atypical pathogens by FilmArray in LRTI patients
Time Frame
From in-hospital to discharge or death, whichever came first, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengchen DUAN, doctor
Phone
13488779977
Email
doctordsc@163.com
Facility Information:
Facility Name
Chian Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengchen DUAN, doctor
Phone
13488779977
Email
doctordsc@163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31229593
Citation
Shengchen D, Gu X, Fan G, Sun R, Wang Y, Yu D, Li H, Zhou F, Xiong Z, Lu B, Zhu G, Cao B. Evaluation of a molecular point-of-care testing for viral and atypical pathogens on intravenous antibiotic duration in hospitalized adults with lower respiratory tract infection: a randomized clinical trial. Clin Microbiol Infect. 2019 Nov;25(11):1415-1421. doi: 10.1016/j.cmi.2019.06.012. Epub 2019 Jun 20.
Results Reference
derived

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The Clinical Value of FA in AHLRI Patients

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