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

NCT ID: NCT04835818

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2022-05-31

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.

Conditions

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Community-acquired Pneumonia Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Reporting

check point-of-care Multiplex PCR for pneumonia pathogens and report results to primary care physician

Group Type EXPERIMENTAL

Provide the panel report to the primary care physician

Intervention Type DIAGNOSTIC_TEST

Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Provide the panel report to the primary care physician

Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Chung Chuang, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Chung Chuang, MD. PhD

Role: CONTACT

886-2-23123456 ext. 65045

Yu-Chung Chuang, MD. PhD

Role: CONTACT

886-972652532

Facility Contacts

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Yu-Chung Chuang, MD PhD

Role: primary

886-2-23123456 ext. 65045

Other Identifiers

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201901147RIND

Identifier Type: -

Identifier Source: org_study_id