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

Sponsor
Mahidol University
Study ID
NCT06782607
Status
Not Yet Recruiting

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Conditions

  • Infectious Disease of Lung
  • Molecular Diagnosis
  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pneumonia Panel by FilmArray — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

First listed
Jan 20, 2025
Start date
Feb 1, 2025
Status verified
Jan 2025
Primary completion
Feb 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: Pneumonia panel group
    Pneumonia panel measurement and changing of antimicrobials according to the result of pneumonia panel
  • No Intervention: No Intervention: Standard of care
    Standard practice

Primary Outcome Measure

Therapeutic decision [Time Frame: 24 hours following the FilmArray results] [ Time Frame: 24 hours following the FilmArray results ]

Central Contacts

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