NCT06782607

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Infectious Disease of Lung
• Molecular Diagnosis
• Pneumonia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-02-01
• Completion: 2027-10-01
• First posted: 2025-01-20
• Last updated: 2025-01-20

Locations

1 site across 1 country: Thailand