Clinical Impact of Rapid Molecular Testing for Pathogens in Patients With Severe Acute Respiratory Illness : A Pragmatic Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Clinical Trial Center

About this trial

Community-acquired pneumonia (CAP) is among the most common reasons for emergency department (ED) visits. A clear understanding of the likely pathogens is essential for the rapid institution of adequate antimicrobial therapy. Due to the indistinguishable clinical symptoms between viral and bacterial pathogens, patients with viral respiratory infection are usually under-evaluated while unnecessary antibacterial agents are more likely to be administered. With the development of highly sensitive end-to-end point-of-care (POC) multiplex PCR system, rapid diagnosis of respiratory pathogens for CAP in the ED becomes possible. Our previous NTUH-VGH cooperative research project demonstrated POC respiratory viral testing' in conjunction with procalcitonin test can reduce the length of hospital stay and antibiotic consumption. However, viral testing alone cannot guide precision antimicrobial treatment. A complete pneumonia pathogen testing panel should include bacteria, virus, atypical pathogens, and resistant genes. In addition, such test need to be completed within about time at a reasonable cost. The difficult missing has been recently achieved. The BIOFIRE®FILMARRAY® Pneumonia Panel is the only FDA approved mPCR test that can test 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses in one test within 45 minutes. Currently, the world is eagerly to learn how this new diagnostic technology can transform the clinical management of pneumonia. With this in mind, the aim of this study is to evaluate the impact of POC pneumonia pathognome wide testing on the antimicrobial use and outcome of patients. We will perform an open label pragmatic parallel comparison between patients with/without the test. The results will inform the pneumonia guideline. Subsequent health economic analysis based on this study will be important to the reimbursement policy of the health insurance of Taiwan.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admitted to the ED

Age ≥18 years old

history of fever or measured fever of ≥ 38 C° and cough

with onset within the last 10 days.

Disqualifiers

Patients receiving palliative care

Patients who declined sample collection

Patients fail to provide written informed consent.

Patients highly suspected or diagnosed pulmonary non-infectious disease (tumor, immune disease, etc) without evidence of infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • The BIOFIRE®FILMARRAY® Pneumonia Panel

    Diagnostic test

    The BIOFIRE®FILMARRAY® Pneumonia Panel is the only FDA approved mPCR test that can test 18bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses in one test within 45 minutes. Using rapid diagnostic test to improve the proportion of antibiotics change, including escalation, de-escalation, discontinuation, or addition of antimicrobial medications in 24 hours within sample collection.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Pneumonia PanelExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The proportion of antibiotics change

The proportion of antibiotics change, including escalation, de-escalation, discontinuation, or addition of antimicrobial medications in 24 hours within sample collection.

Time frame
2 years

Secondary outcomes

1

Patients Prognosis

The proportion of patients re-admitted in 30 days, the average length of hospital stay, 30-day all-cause mortality, duration of intravenous antibiotics, duration of mechanical ventilator.

Time frame
2 years

Other outcomes

Sponsors and contacts

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National Taiwan University Clinical Trial Center

Lead sponsor

National Taiwan University Hospital

Sponsor institution

Taipei Veterans General Hospital, Taiwan

Collaborator

This trial is not recruiting at the moment. You can still explore other options: