Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia
Clinical Impact on Point-of-Care Multiplex Polymerase Chain Reaction (PCR) Testing for Critically Ill Adult Patients With Community-acquired Pneumonia
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2019
CompletedFirst Submitted
Initial submission to the registry
April 5, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedOctober 13, 2021
October 1, 2021
3 years
April 5, 2021
October 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intravenous antibiotic-free day within 14 days
days without intravenous antibiotics within 14 days
up to 14 days
Secondary Outcomes (4)
ICU stay
up to 21 days
Antibiotic-free day within 21 days
21 days
Intravenous antibiotic-free day within 21 days
up to 21 days
Ventilator-free day within 28 days
up to 28 days
Study Arms (2)
Reporting
EXPERIMENTALcheck point-of-care Multiplex PCR for pneumonia pathogens and report results to primary care physician
Usual Care
NO INTERVENTIONcheck 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
Interventions
Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)
Eligibility Criteria
You may qualify if:
- Adult patients (age \>20 y/o)
- ICU admission for acute respiratory failure due to community-acquired pneumonia by clinical diagnosis
- Treatment with endotracheal Intubation
You may not qualify if:
- Aspiration pneumonia (including witnessed aspiration and chronic bedridden status)
- Nosocomial infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu-Chung Chuang, MD. PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2021
First Posted
April 8, 2021
Study Start
May 2, 2019
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
October 13, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share