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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04835818
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Critical Illness Diagnostic Test: Provide the panel report to the primary care physician Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Clinical Impact on Point-of-Care Multiplex Polymerase Chain Reaction (PCR) Testing for Critically Ill Adult Patients With Community-acquired Pneumonia
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Intravenous antibiotic-free day within 14 days [ Time Frame: up to 14 days ]
    days without intravenous antibiotics within 14 days


Secondary Outcome Measures :
  1. ICU stay [ Time Frame: up to 21 days ]
    days of stay in ICU

  2. Antibiotic-free day within 21 days [ Time Frame: 21 days ]
    days without antibiotics within 21 days

  3. Intravenous antibiotic-free day within 21 days [ Time Frame: up to 21 days ]
    days without intravenous antibiotics within 21 days

  4. Ventilator-free day within 28 days [ Time Frame: up to 28 days ]
    days without intravenous antibiotics within 28 days


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04835818


Contacts
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Contact: Yu-Chung Chuang, MD. PhD 886-2-23123456 ext 65045 weischuang@gmail.com
Contact: Yu-Chung Chuang, MD. PhD 886-972652532

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yu-Chung Chuang, MD PhD    886-2-23123456 ext 65045    weischuang@gmail.com   
Sub-Investigator: Ying-Chun Chien, MD         
Sub-Investigator: Wang-Da Liu, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yu-Chung Chuang, MD. PhD National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04835818    
Other Study ID Numbers: 201901147RIND
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Community-acquired Pneumonia
Critical Illness
Point-of-care
Additional relevant MeSH terms:
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Pneumonia
Critical Illness
Respiratory Tract Infections
Infections
 Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes