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FALRI: The Clinical Value of FA in AHLRI Patients

Sponsor
Bin Cao (Other)
Overall Status
Unknown status
CT.gov ID
NCT03391076
Collaborator
BioMérieux (Industry)
800
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
61.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: FilmArray Respiratory Panel
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
The Clinical Value of FilmArray Rapid Viral Testing in Acute Hospitalized Lower Respiratory Infection Patients: A Randomized Controlled Study
Actual Study Start Date :
Sep 21, 2017
Anticipated Primary Completion Date :
Sep 30, 2018
Anticipated Study Completion Date :
Oct 23, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 months]

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

Secondary Outcome Measures

  1. Antibiotics therapy cost [From in-hospital to discharge or death, whichever came first, assessed up to 12 months]

  2. Length of hospital stay (LOS) and/or ICU stay [From in-hospital to discharge or death, whichever came first, assessed up to 12 months]

  3. The correlation between the initial serum PCT level and clinical outcomes/mortality [From in-hospital to discharge or death, whichever came first, assessed up to 12 months]

  4. The detection rate of viruses and atypical pathogens by FilmArray in LRTI patients [From in-hospital to discharge or death, whichever came first, assessed up to 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chian Japan Friendship Hospital Beijing Beijing China

Sponsors and Collaborators

  • Bin Cao
  • BioMérieux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bin Cao, Head of Respiratory Department, Capital Medical University
ClinicalTrials.gov Identifier:
NCT03391076
Other Study ID Numbers:
  • 20170909
First Posted:
Jan 5, 2018
Last Update Posted:
Oct 9, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Infections
Respiratory Tract Infections

Study Results

No Results Posted as of Oct 9, 2018