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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Community-acquired Pneumonia, Critical Illness

Intervention / Treatment
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* Diagnostic Test: Provide the panel report to the primary care physician


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reporting<br>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<br>* Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)<br>|
| No Intervention: Usual Care<br>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?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Illness, Point-of-care, Community-acquired Pneumonia