ClinicalTrials.gg
Status unknownNCT03391076FALRIUpdated Oct 9, 2018

The Clinical Value of FA in AHLRI Patients

An interventional study of FilmArray Respiratory Panel in Lower Respiratory Tract Infection, sponsored by Bin Cao. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Bin Cao · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lower Respiratory Tract Infection
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In context

Lead sponsor

Bin Cao is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults age >= 18 years old
  • Community acquired Pneumonia, acute exacerbation of [AECOPD], acute exacerbation of bronchiectasis.
  • Hospitalization required
  • Form signed

Exclusion criteria

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
  • Form not signed
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
800 participants (estimated)

Study arms

  • Experimental
    FilmArray group

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

    Diagnostic Test: FilmArray Respiratory Panel

  • No intervention
    Routine test group

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

Interventions

  • Diagnostic testFilmArray Respiratory Panel

    An Multi-PCR method which can detect 20 pathogens in 45 minutes.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months

Secondary outcomes

  1. Antibiotics therapy cost

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: From in-hospital to discharge or death, whichever came first, assessed up to 12 months

07

Study locations

1 of 1 sites recruiting
  • Chian Japan Friendship Hospital
    Beijing, Beijing, China
    Recruiting
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References and documents

Publications

  • 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. PubMed 31229593 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03391076
Lead sponsor
Bin Cao
Collaborators
BioMérieux
Responsible party
Bin Cao (Head of Respiratory Department, Capital Medical University) — Sponsor-investigator
First posted
Jan 5, 2018
Start date
Sep 21, 2017
Primary completion
Sep 30, 2018 (estimated)
Completion
Oct 23, 2018 (estimated)
Last update
Oct 9, 2018

Study contacts

Shengchen DUAN, doctor
Contact
doctordsc@163.com
13488779977

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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