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

NCT06605352 | Not Yet Recruiting FDA Device

• 1 other identifier: 201908092RIND, 2024-09-008B
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Community-Acquired Pneumonia (CAP); Pneumonia

Keywords

Community-acquired pneumonia (CAP); multiplex PCR; emergency department (ED); Pneumonia; Procalcitonin(PCT); antimicrobial resistance

Outcome Measures

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.

  2 years

Secondary Outcomes (1)

• Patients Prognosis

  2 years

Study Arms (2)

Pneumonia Panel

EXPERIMENTAL

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.

Diagnostic Test: The BIOFIRE®FILMARRAY® Pneumonia Panel

Control group

NO INTERVENTION

Using current methods (empirical antibiotics) to treat patents with suspected bacterial infections.

Interventions

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.

Pneumonia Panel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the ED
• Age ≥18 years old
• Diagnosis of SARI -modified from the World Health Organization definition:
• history of fever or measured fever of ≥ 38 C° and cough
• with onset within the last 10 days.
• requires hospitalization.
• with SpO2 on presentation less than 95% or respiratory rate more than 20 per minute, or requirement of intubation and mechanical ventilation.

You may not qualify if:

• 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.
• Patients diagnosed with COVID-19 within last 3 months.
• HIV-infected patients.
• Off work hour collected samples will be excluded from the study.
• Patients who died or being transitioned to comfort care within 48 hours of enrollment.
• Sampling Method: random sampling

Sponsors & Collaborators

• National Taiwan University Clinical Trial Center: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng Dist, 100, Taiwan

Location

Related Publications (5)

• Lee SH, Ruan SY, Pan SC, Lee TF, Chien JY, Hsueh PR. Performance of a multiplex PCR pneumonia panel for the identification of respiratory pathogens and the main determinants of resistance from the lower respiratory tract specimens of adult patients in intensive care units. J Microbiol Immunol Infect. 2019 Dec;52(6):920-928. doi: 10.1016/j.jmii.2019.10.009. Epub 2019 Nov 23.

  PMID: 31806539 BACKGROUND

• Murphy CN, Fowler R, Balada-Llasat JM, Carroll A, Stone H, Akerele O, Buchan B, Windham S, Hopp A, Ronen S, Relich RF, Buckner R, Warren DA, Humphries R, Campeau S, Huse H, Chandrasekaran S, Leber A, Everhart K, Harrington A, Kwong C, Bonwit A, Dien Bard J, Naccache S, Zimmerman C, Jones B, Rindlisbacher C, Buccambuso M, Clark A, Rogatcheva M, Graue C, Bourzac KM. Multicenter Evaluation of the BioFire FilmArray Pneumonia/Pneumonia Plus Panel for Detection and Quantification of Agents of Lower Respiratory Tract Infection. J Clin Microbiol. 2020 Jun 24;58(7):e00128-20. doi: 10.1128/JCM.00128-20. Print 2020 Jun 24.

  PMID: 32350043 BACKGROUND

• Kosai K, Akamatsu N, Ota K, Mitsumoto-Kaseida F, Sakamoto K, Hasegawa H, Izumikawa K, Mukae H, Yanagihara K. BioFire FilmArray Pneumonia Panel enhances detection of pathogens and antimicrobial resistance in lower respiratory tract specimens. Ann Clin Microbiol Antimicrob. 2022 Jun 4;21(1):24. doi: 10.1186/s12941-022-00512-8.

  PMID: 35659683 BACKGROUND

• Buchan BW, Windham S, Balada-Llasat JM, Leber A, Harrington A, Relich R, Murphy C, Dien Bard J, Naccache S, Ronen S, Hopp A, Mahmutoglu D, Faron ML, Ledeboer NA, Carroll A, Stone H, Akerele O, Everhart K, Bonwit A, Kwong C, Buckner R, Warren D, Fowler R, Chandrasekaran S, Huse H, Campeau S, Humphries R, Graue C, Huang A. Practical Comparison of the BioFire FilmArray Pneumonia Panel to Routine Diagnostic Methods and Potential Impact on Antimicrobial Stewardship in Adult Hospitalized Patients with Lower Respiratory Tract Infections. J Clin Microbiol. 2020 Jun 24;58(7):e00135-20. doi: 10.1128/JCM.00135-20. Print 2020 Jun 24.

  PMID: 32350045 BACKGROUND

• Jitmuang A, Puttinad S, Hemvimol S, Pansasiri S, Horthongkham N. A multiplex pneumonia panel for diagnosis of hospital-acquired and ventilator-associated pneumonia in the era of emerging antimicrobial resistance. Front Cell Infect Microbiol. 2022 Oct 12;12:977320. doi: 10.3389/fcimb.2022.977320. eCollection 2022.

  PMID: 36310855 BACKGROUND

Related Links

• BioFire pneumonia panel website

MeSH Terms

Conditions

Community-Acquired Pneumonia; Pneumonia; Emergencies

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chien-Chang Lee, Doctor of Science

CONTACT

+886-972-651-951; cclee100@gmail.com

Yi-Tzu Lee, doctor

CONTACT

+886-920-610-054; s851009@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: National Taiwan University Hospital

Model Details: 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

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)