NCT03391076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

December 7, 2017

Last Update Submit

October 7, 2018

Conditions

Lower Respiratory Tract Infection

Outcome Measures

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.

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

Secondary Outcomes (4)

  • Antibiotics therapy cost

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

  • Length of hospital stay (LOS) and/or ICU stay

    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

    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

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

Study Arms (2)

FilmArray group

EXPERIMENTAL

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

Diagnostic Test: FilmArray Respiratory Panel

Routine test group

NO INTERVENTION

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

Interventions

FilmArray Respiratory PanelDIAGNOSTIC_TEST

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

FilmArray group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chian Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 31229593DERIVED

Central Study Contacts

Shengchen DUAN, doctor

CONTACT

13488779977doctordsc@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Respiratory Department

Study Record Dates

First Submitted

December 7, 2017

First Posted

January 5, 2018

Study Start

September 21, 2017

Primary Completion

September 30, 2018

Study Completion

October 23, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations

CN(1)