The Clinical Value of FA in AHLRI Patients

NCT ID: NCT03391076

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-21

Study Completion Date

2018-10-23

Brief Summary

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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.

Detailed Description

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Conditions

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Lower Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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FilmArray group

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

Group Type EXPERIMENTAL

FilmArray Respiratory Panel

Intervention Type DIAGNOSTIC_TEST

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

Routine test group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FilmArray Respiratory Panel

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioMérieux

INDUSTRY

Sponsor Role collaborator

Bin Cao

OTHER

Sponsor Role lead

Responsible Party

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Bin Cao

Head of Respiratory Department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chian Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shengchen DUAN, doctor

Role: CONTACT

13488779977

Facility Contacts

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Shengchen DUAN, doctor

Role: primary

13488779977

References

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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.

Reference Type DERIVED
PMID: 31229593 (View on PubMed)

Other Identifiers

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20170909

Identifier Type: -

Identifier Source: org_study_id

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