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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06782607
Enrollment
80
Registered
2025-01-20
Start date
2025-02-01
Completion date
2027-10-01
Last updated
2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease of Lung, Molecular Diagnosis, Pneumonia

Brief summary

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.

Detailed description

Not provided

Interventions

DIAGNOSTIC_TESTPneumonia 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.

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Thailand

Contacts

Primary ContactAdhiratha Boonyasiri, MD, MSc, PhD
adhiratha.bon@mahidol.ac.th+664192688

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026