The Clinical Value of FA in AHLRI Patients (FALRI)

October 7, 2018 updated by: Bin Cao

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Chian Japan Friendship Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FilmArray group
Patients in this group will use FilmArray Respiratory Panel to test potential viral pathogens.
Diagnostic test: FilmArray Respiratory Panel
An Multi-PCR method which can detect 20 pathogens in 45 minutes.
No Intervention: Routine test group
Patients in this group will use clinical routine methods to test potential viral pathogens.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length (days) of antibiotics therapy in hospital between two groups.
Time Frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
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 Outcome Measures

Outcome Measure
Time Frame
Antibiotics therapy cost
Time Frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
From in-hospital to discharge or death, whichever came first, assessed up to 12 months
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
From 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/mortality
Time Frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
From 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 patients
Time Frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months
From in-hospital to discharge or death, whichever came first, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bin Cao

Collaborators

BioMérieux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Anticipated)

September 30, 2018

Study Completion (Anticipated)

October 23, 2018

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 7, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20170909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Respiratory Tract Infection

Clinical Trials on FilmArray Respiratory Panel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe