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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835818
• Other study ID #: 201901147RIND
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: May 2022

Study information

• Verified date: October 2021
• Source: National Taiwan University Hospital
• Contact: Yu-Chung Chuang, MD. PhD
• Phone: 886-2-23123456
• Email: weischuang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Critical Illness
• Pneumonia

Intervention

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)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intravenous antibiotic-free day within 14 days	days without intravenous antibiotics within 14 days	up to 14 days
Secondary	ICU stay	days of stay in ICU	up to 21 days
Secondary	Antibiotic-free day within 21 days	days without antibiotics within 21 days	21 days
Secondary	Intravenous antibiotic-free day within 21 days	days without intravenous antibiotics within 21 days	up to 21 days
Secondary	Ventilator-free day within 28 days	days without intravenous antibiotics within 28 days	up to 28 days