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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04835818

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

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

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

Primary Outcome Measures

Intravenous antibiotic-free day within 14 days [up to 14 days]
days without intravenous antibiotics within 14 days

Secondary Outcome Measures

ICU stay [up to 21 days]
days of stay in ICU
Antibiotic-free day within 21 days [21 days]
days without antibiotics within 21 days
Intravenous antibiotic-free day within 21 days [up to 21 days]
days without intravenous antibiotics within 21 days
Ventilator-free day within 28 days [up to 28 days]
days without intravenous antibiotics within 28 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT04835818

Other Study ID Numbers:

201901147RIND

First Posted:

Apr 8, 2021

Last Update Posted:

Oct 13, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

Community-acquired Pneumonia

Critical Illness

Point-of-care

Additional relevant MeSH terms:

Pneumonia

Critical Illness

Study Results

No Results Posted as of Oct 13, 2021