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

October 11, 2021 updated by: National Taiwan University Hospital

Clinical Impact on Point-of-Care Multiplex Polymerase Chain Reaction (PCR) Testing for Critically Ill Adult Patients With Community-acquired Pneumonia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yu-Chung Chuang, MD. PhD
  • Phone Number: 886-972652532

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Sub-Investigator:
          • Ying-Chun Chien, MD
        • Sub-Investigator:
          • Wang-Da Liu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reporting
check point-of-care Multiplex PCR for pneumonia pathogens and report results to primary care physician
Diagnostic test: Provide the panel report to the primary care physician
Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)
No Intervention: Usual Care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intravenous antibiotic-free day within 14 days
Time Frame: up to 14 days
days without intravenous antibiotics within 14 days
up to 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU stay
Time Frame: up to 21 days
days of stay in ICU
up to 21 days
Antibiotic-free day within 21 days
Time Frame: 21 days
days without antibiotics within 21 days
21 days
Intravenous antibiotic-free day within 21 days
Time Frame: up to 21 days
days without intravenous antibiotics within 21 days
up to 21 days
Ventilator-free day within 28 days
Time Frame: up to 28 days
days without intravenous antibiotics within 28 days
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yu-Chung Chuang, MD. PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2019

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 5, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 11, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201901147RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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