Clinical Impact of a Multiplex Rapid Diagnostic Pneumonia Panel Testing in Critically-ill Patients with Severe Hospital-acquired Pneumonia, Ventilator-associated Pneumonia and Community-acquired Pneumonia with High Risk of Multidrug Resistant Pathogen

The objective of the research is to ascertain the influence of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalised in the ICU for severe respiratory disease.

The diagnostic process for pneumonia has become significantly more intricate over the past decade due to the interference of the biological, radiological, and clinical criteria of patients hospitalised in the intensive care unit with the conventional criteria for the diagnosis of severe respiratory diseases. Additionally, patients who are hospitalised in the ICU are at a heightened risk of contracting other associated infections. Consequently, patients are frequently administered antibiotics, whether or not they are effective, as it is challenging to promptly determine the aetiology of their symptoms using conventional methods.

To enhance the diagnostic and therapeutic aspects of their treatment, we implemented a novel syndromic molecular test in our laboratories. This test is designed to expedite and enhance the management of pneumonia and the stewardship of antibiotics. This research will include 80 to 100 adult patients hospitalized in ICU between Feb 2025 and Feb 2027. It will take place within the Siriraj Hospital, Bangkok, Thailand.

Study Overview

• Status: Not yet recruiting
• Conditions: Pneumonia; Molecular Diagnosis; Infectious Disease of Lung
• Intervention / Treatment: Diagnostic test: Pneumonia Panel by FilmArray

Detailed Description

Not provided

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adhiratha Boonyasiri, MD, MSc, PhD; Phone Number: +664192688; Email: adhiratha.bon@mahidol.ac.th

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Faculty of medicine Siriraj hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients who have received complete information about the research and who have not objected to the use of its data
• Patients with suspected pneumonia infection

Exclusion Criteria: Patients with following conditions;

• Active immediate life-threatening cardiac arrhythmia, defined as ventricular tachycardia and ventricular fibrillation
• Acute cerebral vascular event, including both acute ischemic stroke or intracranial hemorrhage Acute coronary syndrome
• Cardiogenic shock
• Life-threatening gastrointestinal hemorrhage
• Drug overdose
• Advanced-stage cancer with predicted survival less than 1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Pneumonia panel group; Pneumonia panel measurement and changing of antimicrobials according to the result of pneumonia panel	Diagnostic test: Pneumonia Panel by FilmArray; The Pneumonia Panel comprehensively identifies 33 potential pathogen targets from sputum-like (including endotracheal aspirate) and bronchoalveolar lavage (BAL)-like (including mini-BAL) samples. For 15 of the bacteria, the Pneumonia Panel provides semi-quantitative results, which may help determine whether an organism is a colonizer or a pathogen.
No Intervention: No Intervention: Standard of care; Standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic decision [Time Frame: 24 hours following the FilmArray results]	Antibiotic prescription modification following the FilmArray results as: No prescription No change in antibiotic utilization Antibiotic initiation Antibiotic escalation Antibiotic de-escalation Antibiotic discontinuation	24 hours following the FilmArray results

Collaborators and Investigators

• Sponsor: Mahidol University

Publications and helpful links

General Publications

• 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.
• Stafylaki D, Maraki S, Vaporidi K, Georgopoulos D, Kontoyiannis DP, Kofteridis DP, Chamilos G. Impact of Molecular Syndromic Diagnosis of Severe Pneumonia in the Management of Critically Ill Patients. Microbiol Spectr. 2022 Oct 26;10(5):e0161622. doi: 10.1128/spectrum.01616-22. Epub 2022 Sep 26.
• High J, Enne VI, Barber JA, Brealey D, Turner DA, Horne R, Peters M, Dhesi Z, Wagner AP, Pandolfo AM, Stirling S, Russell C, O'Grady J, Swart AM, Gant V, Livermore DM; INHALE Study Group. INHALE: the impact of using FilmArray Pneumonia Panel molecular diagnostics for hospital-acquired and ventilator-associated pneumonia on antimicrobial stewardship and patient outcomes in UK Critical Care-study protocol for a multicentre randomised controlled trial. Trials. 2021 Oct 7;22(1):680. doi: 10.1186/s13063-021-05618-6.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Infections; Communicable Diseases; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 010/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No