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Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia

Primary Purpose

Community-acquired Pneumonia, Critical Illness

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Provide the panel report to the primary care physician
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Community-acquired Pneumonia focused on measuring Community-acquired Pneumonia, Critical Illness, Point-of-care

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (age >20 y/o)
  • ICU admission for acute respiratory failure due to community-acquired pneumonia by clinical diagnosis
  • Treatment with endotracheal Intubation

Exclusion Criteria:

  • Aspiration pneumonia (including witnessed aspiration and chronic bedridden status)
  • Nosocomial infection

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reporting

Usual Care

Arm Description

check point-of-care Multiplex PCR for pneumonia pathogens and report results to primary care physician

check point-of-care Multiplex PCR for pneumonia pathogens but do NOT report results to primary care physician. Let primary care physician provide usual standard care

Outcomes

Primary Outcome Measures

Intravenous antibiotic-free day within 14 days
days without intravenous antibiotics within 14 days

Secondary Outcome Measures

ICU stay
days of stay in ICU
Antibiotic-free day within 21 days
days without antibiotics within 21 days
Intravenous antibiotic-free day within 21 days
days without intravenous antibiotics within 21 days
Ventilator-free day within 28 days
days without intravenous antibiotics within 28 days

Full Information

First Posted
April 5, 2021
Last Updated
October 11, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04835818
Brief Title
Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia
Official Title
Clinical Impact on Point-of-Care Multiplex Polymerase Chain Reaction (PCR) Testing for Critically Ill Adult Patients With Community-acquired Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Clinical Impact on Point-of-Care Multiplex PCR Testing for Critically Ill Adult Patients With Community-acquired Pneumonia - A cluster randomization study in ICU units within one medical center.
Detailed Description
Point-of-Care Multiplex PCR Testing could narrow down the pathogens causing severe community-acquired pneumonia(CAP). Our hypothesis is that the result of Point-of-Care Multiplex PCR Testing could help primary physician to reduce antibiotics use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia, Critical Illness
Keywords
Community-acquired Pneumonia, Critical Illness, Point-of-care

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reporting
Arm Type
Experimental
Arm Description
check point-of-care Multiplex PCR for pneumonia pathogens and report results to primary care physician
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
check point-of-care Multiplex PCR for pneumonia pathogens but do NOT report results to primary care physician. Let primary care physician provide usual standard care
Intervention Type
Diagnostic Test
Intervention Name(s)
Provide the panel report to the primary care physician
Intervention Description
Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)
Primary Outcome Measure Information:
Title
Intravenous antibiotic-free day within 14 days
Description
days without intravenous antibiotics within 14 days
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
ICU stay
Description
days of stay in ICU
Time Frame
up to 21 days
Title
Antibiotic-free day within 21 days
Description
days without antibiotics within 21 days
Time Frame
21 days
Title
Intravenous antibiotic-free day within 21 days
Description
days without intravenous antibiotics within 21 days
Time Frame
up to 21 days
Title
Ventilator-free day within 28 days
Description
days without intravenous antibiotics within 28 days
Time Frame
up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (age >20 y/o) ICU admission for acute respiratory failure due to community-acquired pneumonia by clinical diagnosis Treatment with endotracheal Intubation Exclusion Criteria: Aspiration pneumonia (including witnessed aspiration and chronic bedridden status) Nosocomial infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chung Chuang, MD. PhD
Phone
886-2-23123456
Ext
65045
Email
weischuang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chung Chuang, MD. PhD
Phone
886-972652532
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chung Chuang, MD. PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Chung Chuang, MD PhD
Phone
886-2-23123456
Ext
65045
Email
weischuang@gmail.com
First Name & Middle Initial & Last Name & Degree
Ying-Chun Chien, MD
First Name & Middle Initial & Last Name & Degree
Wang-Da Liu, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia

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